Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.
Regulatory requirements for drug approval unit3Aman chourasia
New Drug Application (NDA) is an application submitted to the individual regulatory authority for authorization to market a new drug i.e. innovative product. To gain this permission a sponsor submits preclinical and clinical test data for analyzing the drug information, description of manufacturing trials.
This document provides guidance on IND (Investigational New Drug) regulations for initial Phase 1 clinical trials. It clarifies that Phase 1 IND submissions require basic information to ensure safety rather than detailed development plans. For protocols, manufacturing information, and other sections, flexibility is allowed to adapt to early study results. The focus should be on safety aspects like monitoring and dose adjustments rather than predetermined experimental designs. This guidance aims to help sponsors provide sufficient information without being overly burdensome for early phase trials.
Where are you in your drug development journey? Find out how to expedite your drug development program. View our drug development journey map. Download the document to zoom in and view details.
The document provides an overview of the New Drug Application (NDA) process. It discusses that an NDA is required for approval to market a new drug in the US. The goals of an NDA are to demonstrate a drug's safety, efficacy, appropriate labeling, and quality manufacturing. An NDA contains extensive data from non-clinical and clinical trials. It follows a common technical document format and is reviewed by the FDA to determine if the drug's benefits outweigh the risks for approval.
Importance of guidelines in regulatory toxicity testingChander K Negi
Importance of Guidelines in Regulatory Toxicity studies
Guidelines are the consensus document accepted by a regulatory body
Prevent duplication of clinical trials in humans
Ensure SAFETY, EFFICACY and QUALITY of medicines
Minimize the use of animal testing without compromising safety and effectiveness
IMPACT OF REGULATIONS ON MEDICAL DEVICES IN CONTEXT OF INNOVATIONSJAYA PRAKASH VELUCHURI
The document discusses the impact of regulations on innovation in the medical devices sector. It provides background on regulations in the United States and European Union, which classify devices based on risk and require clinical trials and quality standards. Regulations influence the entire innovation cycle from design to post-market surveillance. While regulations aim to ensure safety, they can also introduce barriers and uncertainty that slow innovation. Emerging technologies like nanomaterials and 3D bioprinting further complicate classification and evaluation. The document argues for collaboration between developers and regulators to streamline processes while encouraging innovation and access to new treatments.
Challenges in regulatory filing of generic products in Europe and Malyasia.rkreddy98666
The document discusses the challenges and processes for regulatory filing of generic products in Europe and Malaysia. It provides definitions of key terms like generic products and innovator products. The major differences between innovator and generic products are described. The generic drug development process and requirements are outlined. The various procedures for marketing authorization of generics in Europe like centralized, decentralized, national and mutual recognition procedures are summarized. The document also provides an overview of the ASEAN Common Technical Document (ACTD) format and lists the typical documents required for a generic drug filing in Malaysia.
Regulatory requirements for drug approval unit3Aman chourasia
New Drug Application (NDA) is an application submitted to the individual regulatory authority for authorization to market a new drug i.e. innovative product. To gain this permission a sponsor submits preclinical and clinical test data for analyzing the drug information, description of manufacturing trials.
This document provides guidance on IND (Investigational New Drug) regulations for initial Phase 1 clinical trials. It clarifies that Phase 1 IND submissions require basic information to ensure safety rather than detailed development plans. For protocols, manufacturing information, and other sections, flexibility is allowed to adapt to early study results. The focus should be on safety aspects like monitoring and dose adjustments rather than predetermined experimental designs. This guidance aims to help sponsors provide sufficient information without being overly burdensome for early phase trials.
Where are you in your drug development journey? Find out how to expedite your drug development program. View our drug development journey map. Download the document to zoom in and view details.
The document provides an overview of the New Drug Application (NDA) process. It discusses that an NDA is required for approval to market a new drug in the US. The goals of an NDA are to demonstrate a drug's safety, efficacy, appropriate labeling, and quality manufacturing. An NDA contains extensive data from non-clinical and clinical trials. It follows a common technical document format and is reviewed by the FDA to determine if the drug's benefits outweigh the risks for approval.
Importance of guidelines in regulatory toxicity testingChander K Negi
Importance of Guidelines in Regulatory Toxicity studies
Guidelines are the consensus document accepted by a regulatory body
Prevent duplication of clinical trials in humans
Ensure SAFETY, EFFICACY and QUALITY of medicines
Minimize the use of animal testing without compromising safety and effectiveness
IMPACT OF REGULATIONS ON MEDICAL DEVICES IN CONTEXT OF INNOVATIONSJAYA PRAKASH VELUCHURI
The document discusses the impact of regulations on innovation in the medical devices sector. It provides background on regulations in the United States and European Union, which classify devices based on risk and require clinical trials and quality standards. Regulations influence the entire innovation cycle from design to post-market surveillance. While regulations aim to ensure safety, they can also introduce barriers and uncertainty that slow innovation. Emerging technologies like nanomaterials and 3D bioprinting further complicate classification and evaluation. The document argues for collaboration between developers and regulators to streamline processes while encouraging innovation and access to new treatments.
Challenges in regulatory filing of generic products in Europe and Malyasia.rkreddy98666
The document discusses the challenges and processes for regulatory filing of generic products in Europe and Malaysia. It provides definitions of key terms like generic products and innovator products. The major differences between innovator and generic products are described. The generic drug development process and requirements are outlined. The various procedures for marketing authorization of generics in Europe like centralized, decentralized, national and mutual recognition procedures are summarized. The document also provides an overview of the ASEAN Common Technical Document (ACTD) format and lists the typical documents required for a generic drug filing in Malaysia.
This document discusses Good Laboratory Practice (GLP) regulations, which were established in the 1970s in response to malpractice in research and development. GLP regulations set standards for properly managing and organizing studies to generate regulatory data. The key points of GLP include ensuring adequate resources, characterizing test materials, following study plans and procedures, maintaining raw data and final reports, and implementing quality assurance programs. The Organization for Economic Cooperation and Development (OECD) later published GLP Principles that were adopted by its member states.
This document provides guidance on the Investigator's Brochure (IB), which compiles clinical and nonclinical data on investigational products relevant for human subject studies. The IB aims to inform investigators and others about the product's dose, administration, and safety monitoring. It also helps clinicians independently assess the risks and benefits of a proposed trial. The IB includes a summary of nonclinical pharmacology, toxicology, and human effects studies. It provides guidance to investigators on understanding the potential risks, adverse reactions, and precautions needed for safe clinical trial conduct.
The document discusses an Investigational New Drug Application (IND), which is a submission to the FDA requesting permission to study an experimental drug in clinical trials. An IND provides safety data from animal studies and details of the proposed clinical trials. It includes information on the drug's chemistry, manufacturing, pharmacology and any previous human experience. The IND process allows a drug to move through preclinical and clinical testing in humans while being monitored by the FDA to ensure the protection of clinical trial subjects.
Clinical trials and new drug developmentRahul Bhati
- The drug development process involves several phases of clinical trials and regulatory approval before a new drug can be approved and marketed. Key phases include pre-clinical testing in animals, followed by Phase I-III clinical trials in humans to test safety, efficacy, and proper dosing.
- After successful Phase III trials, companies submit a New Drug Application to regulators like the FDA with all clinical trial data. If approved, the drug is monitored in Phase IV post-marketing trials and surveillance.
- The overall process takes an average of 8-12 years and costs $500-600 million, with only about 20% of candidate drugs ultimately being approved due to rigorous testing requirements.
This document outlines the key components and structure of clinical research protocols. It discusses that protocols provide a written description and scientific rationale for research involving human subjects. Protocols ensure sufficient information is gathered on safety and receive approval from health authorities and ethics committees. The document then lists and describes the typical parts of a protocol, including the title page, objectives, study design, safety considerations, statistical analysis plan, and informed consent section. It emphasizes protocols clarify the research question, existing knowledge, objectives, study design, and provide guidelines for the research team.
Regulatory framework for new drug developmentDr. Mohit Kulmi
The regulatory framework for new drug development involves a lengthy multi-step process including drug discovery, pre-clinical research, and clinical trials on humans to test safety and efficacy. Key aspects of the framework include guidelines from the International Conference on Harmonisation (ICH) to harmonize technical requirements globally, oversight of clinical trials by institutional review boards, and Good Clinical Practice (GCP) standards to ensure trials are scientifically sound and respect participants. The overall goal is to develop new medications efficiently and ethically while protecting human subjects.
regulatory requirements for drug approval ( IP-2 / UNIT -3 )JAYACHANDRA AKUTHOTA
The document discusses regulatory requirements for drug approval. It covers the drug development process including non-clinical and clinical development teams. The non-clinical team conducts pre-clinical studies in animals to evaluate efficacy, safety, and viability of manufacturing. Clinical trials have multiple phases to test drugs on humans. A New Drug Application is submitted to regulatory authorities for marketing approval and includes preclinical and clinical data. The drug development process takes 10-12 years and involves interactions between scientific disciplines.
The document discusses the International Conference on Harmonisation (ICH), which aims to harmonize technical requirements for pharmaceutical registration across regions to ensure safe, effective, and high quality medicines. It outlines ICH's objectives, organizational structure including working groups and guidelines, and harmonization process. ICH has produced over 50 guidelines on quality, safety, efficacy, and multidisciplinary topics to eliminate duplication in drug development.
The document discusses the requirements and guidance for Investigational Medicinal Product Dossiers (IMPDs) and Investigator Brochures (IBs) for clinical trials conducted in the European Union. It provides an overview of the key elements that must be included in an IMPD when applying for clinical trial authorization, such as quality, manufacturing, and non-clinical and clinical study summaries. It also summarizes the sections and information that should be contained in an IB, including physical/chemical properties, non-clinical pharmacology and toxicology results, known human effects, and guidance for investigators.
HUMAN CHALLENGE STUDIES TO ACCELERATE CORONA VIRUS VACCINE LICENSUREJAYA PRAKASH VELUCHURI
This document proposes conducting human challenge studies to accelerate the development and licensure of coronavirus vaccines. It outlines a proposed study design where volunteers would be exposed to SARS-CoV-2 after receiving a candidate vaccine or placebo. If efficacy was shown, an expanded safety study of 3000+ people would be conducted. Together, these could potentially cut 1-1.5 years off the standard development timeline and save thousands or millions of lives. Appropriate precautions and oversight would be needed given the risks of exposing volunteers to the virus.
Regulatory requirements for drug approval Namdeo Shinde
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICESArunpandiyan59
This document provides an overview of regulations for combination products and medical devices in the United States and India. It discusses what combination products are, examples of combination products, and the roles of the US FDA Office of Combination Products in classifying and assigning combination products for review. It also summarizes the regulatory requirements for medical devices in the US, including establishment registration, medical device listing, premarket notification, premarket approval, and quality system regulations. The latest developments in medical device regulation in India are also briefly outlined.
The document provides an overview of ICH-GCP (Good Clinical Practice) guidelines, which are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The summary discusses the key sections and principles of ICH-GCP, which aim to protect trial subjects and ensure valid clinical trial data. It outlines the historical background and development of GCP standards from the Nuremberg Code to the ICH-GCP guidelines of 1996. The document reviews responsibilities of ethics committees, sponsors, investigators, clinical trial protocols, and informed consent processes.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
This document provides an overview of Abbreviated New Drug Applications (ANDAs) in 3 sentences or less:
The document introduces ANDAs as applications submitted to FDA to review and approve generic drug products once approved, allowing manufacturers to market safe and effective low-cost alternatives, and discusses various topics related to ANDA guidelines, requirements, review process, and regulations. It is dedicated to the author's son and aims to provide information to both academia and industry through free websites and articles to support millions of readers.
Drug development involves rigorous pre-clinical and clinical testing to prove a drug is safe and effective. Pre-clinical testing involves laboratory and animal studies. Clinical trials in humans have four phases, with each subsequent phase involving more subjects to further evaluate safety, efficacy, and optimal dosage. After Phase III trials demonstrate a drug's benefits outweigh its risks, a New Drug Application is submitted to regulators for review. If approved, Phase IV trials continue monitoring the drug's long-term safety profile after market approval. The entire process from discovery to market approval takes an average of 8-12 years and costs $800-900 million.
The document provides an overview of the regulatory process for bringing a new drug to market, beginning with pre-clinical studies and submission of an Investigational New Drug (IND) application to the FDA. If approved, the IND allows clinical trials to be conducted in three phases to evaluate safety and efficacy. If phase 3 trials demonstrate a drug is safe and effective, a New Drug Application or Biologics License Application can be submitted for approval to market the drug. Ongoing monitoring of safety continues even after approval.
The document discusses drug design and the drug development process. It describes the two main types of drug design: ligand-based drug design, which relies on knowledge of molecules that bind to the biological target, and structure-based drug design, which models the 3D structure of a protein target. The drug development process involves six main stages: hit identification, pre-clinical studies, manufacturing, clinical trials, regulatory evaluation, and marketing. Overall, drug discovery and development is a complex, expensive process that can take 15 years from initial screening to FDA approval and market launch.
This document provides information about an investigational drug project submitted by Tashi Choezom for her B.Pharmacy degree. It discusses the various phases of drug development including drug discovery, characterization of investigational drugs, formulation, pharmacokinetics, preclinical toxicity studies, the Investigational New Drug application process, bioanalytical and clinical trials. The project is supervised by Kriti Bhadoria and submitted to Veer Madho Singh Bhandari Uttarakhand Technical University.
This document discusses Good Laboratory Practice (GLP) regulations, which were established in the 1970s in response to malpractice in research and development. GLP regulations set standards for properly managing and organizing studies to generate regulatory data. The key points of GLP include ensuring adequate resources, characterizing test materials, following study plans and procedures, maintaining raw data and final reports, and implementing quality assurance programs. The Organization for Economic Cooperation and Development (OECD) later published GLP Principles that were adopted by its member states.
This document provides guidance on the Investigator's Brochure (IB), which compiles clinical and nonclinical data on investigational products relevant for human subject studies. The IB aims to inform investigators and others about the product's dose, administration, and safety monitoring. It also helps clinicians independently assess the risks and benefits of a proposed trial. The IB includes a summary of nonclinical pharmacology, toxicology, and human effects studies. It provides guidance to investigators on understanding the potential risks, adverse reactions, and precautions needed for safe clinical trial conduct.
The document discusses an Investigational New Drug Application (IND), which is a submission to the FDA requesting permission to study an experimental drug in clinical trials. An IND provides safety data from animal studies and details of the proposed clinical trials. It includes information on the drug's chemistry, manufacturing, pharmacology and any previous human experience. The IND process allows a drug to move through preclinical and clinical testing in humans while being monitored by the FDA to ensure the protection of clinical trial subjects.
Clinical trials and new drug developmentRahul Bhati
- The drug development process involves several phases of clinical trials and regulatory approval before a new drug can be approved and marketed. Key phases include pre-clinical testing in animals, followed by Phase I-III clinical trials in humans to test safety, efficacy, and proper dosing.
- After successful Phase III trials, companies submit a New Drug Application to regulators like the FDA with all clinical trial data. If approved, the drug is monitored in Phase IV post-marketing trials and surveillance.
- The overall process takes an average of 8-12 years and costs $500-600 million, with only about 20% of candidate drugs ultimately being approved due to rigorous testing requirements.
This document outlines the key components and structure of clinical research protocols. It discusses that protocols provide a written description and scientific rationale for research involving human subjects. Protocols ensure sufficient information is gathered on safety and receive approval from health authorities and ethics committees. The document then lists and describes the typical parts of a protocol, including the title page, objectives, study design, safety considerations, statistical analysis plan, and informed consent section. It emphasizes protocols clarify the research question, existing knowledge, objectives, study design, and provide guidelines for the research team.
Regulatory framework for new drug developmentDr. Mohit Kulmi
The regulatory framework for new drug development involves a lengthy multi-step process including drug discovery, pre-clinical research, and clinical trials on humans to test safety and efficacy. Key aspects of the framework include guidelines from the International Conference on Harmonisation (ICH) to harmonize technical requirements globally, oversight of clinical trials by institutional review boards, and Good Clinical Practice (GCP) standards to ensure trials are scientifically sound and respect participants. The overall goal is to develop new medications efficiently and ethically while protecting human subjects.
regulatory requirements for drug approval ( IP-2 / UNIT -3 )JAYACHANDRA AKUTHOTA
The document discusses regulatory requirements for drug approval. It covers the drug development process including non-clinical and clinical development teams. The non-clinical team conducts pre-clinical studies in animals to evaluate efficacy, safety, and viability of manufacturing. Clinical trials have multiple phases to test drugs on humans. A New Drug Application is submitted to regulatory authorities for marketing approval and includes preclinical and clinical data. The drug development process takes 10-12 years and involves interactions between scientific disciplines.
The document discusses the International Conference on Harmonisation (ICH), which aims to harmonize technical requirements for pharmaceutical registration across regions to ensure safe, effective, and high quality medicines. It outlines ICH's objectives, organizational structure including working groups and guidelines, and harmonization process. ICH has produced over 50 guidelines on quality, safety, efficacy, and multidisciplinary topics to eliminate duplication in drug development.
The document discusses the requirements and guidance for Investigational Medicinal Product Dossiers (IMPDs) and Investigator Brochures (IBs) for clinical trials conducted in the European Union. It provides an overview of the key elements that must be included in an IMPD when applying for clinical trial authorization, such as quality, manufacturing, and non-clinical and clinical study summaries. It also summarizes the sections and information that should be contained in an IB, including physical/chemical properties, non-clinical pharmacology and toxicology results, known human effects, and guidance for investigators.
HUMAN CHALLENGE STUDIES TO ACCELERATE CORONA VIRUS VACCINE LICENSUREJAYA PRAKASH VELUCHURI
This document proposes conducting human challenge studies to accelerate the development and licensure of coronavirus vaccines. It outlines a proposed study design where volunteers would be exposed to SARS-CoV-2 after receiving a candidate vaccine or placebo. If efficacy was shown, an expanded safety study of 3000+ people would be conducted. Together, these could potentially cut 1-1.5 years off the standard development timeline and save thousands or millions of lives. Appropriate precautions and oversight would be needed given the risks of exposing volunteers to the virus.
Regulatory requirements for drug approval Namdeo Shinde
1. Regulatory requirements for drug approval were introduced after tragic incidents led to deaths, to ensure safety and efficacy of new drugs. Countries have different regulatory agencies that new drugs must be approved by before marketing.
2. The drug development process takes 10-12 years and involves multiple scientific disciplines working together. Non-clinical and clinical trials are conducted to characterize the drug candidate and determine safety and dosing in humans.
3. A New Drug Application contains clinical and manufacturing data submitted to regulatory agencies for review and potential approval to market a new drug. Bioequivalence studies ensure generic drugs have consistent quality, efficacy and safety compared to brand name drugs.
REGULATIONS FOR COMBINATION PRODUCTS AND MEDICAL DEVICESArunpandiyan59
This document provides an overview of regulations for combination products and medical devices in the United States and India. It discusses what combination products are, examples of combination products, and the roles of the US FDA Office of Combination Products in classifying and assigning combination products for review. It also summarizes the regulatory requirements for medical devices in the US, including establishment registration, medical device listing, premarket notification, premarket approval, and quality system regulations. The latest developments in medical device regulation in India are also briefly outlined.
The document provides an overview of ICH-GCP (Good Clinical Practice) guidelines, which are international ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. The summary discusses the key sections and principles of ICH-GCP, which aim to protect trial subjects and ensure valid clinical trial data. It outlines the historical background and development of GCP standards from the Nuremberg Code to the ICH-GCP guidelines of 1996. The document reviews responsibilities of ethics committees, sponsors, investigators, clinical trial protocols, and informed consent processes.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
This document provides an overview of Abbreviated New Drug Applications (ANDAs) in 3 sentences or less:
The document introduces ANDAs as applications submitted to FDA to review and approve generic drug products once approved, allowing manufacturers to market safe and effective low-cost alternatives, and discusses various topics related to ANDA guidelines, requirements, review process, and regulations. It is dedicated to the author's son and aims to provide information to both academia and industry through free websites and articles to support millions of readers.
Drug development involves rigorous pre-clinical and clinical testing to prove a drug is safe and effective. Pre-clinical testing involves laboratory and animal studies. Clinical trials in humans have four phases, with each subsequent phase involving more subjects to further evaluate safety, efficacy, and optimal dosage. After Phase III trials demonstrate a drug's benefits outweigh its risks, a New Drug Application is submitted to regulators for review. If approved, Phase IV trials continue monitoring the drug's long-term safety profile after market approval. The entire process from discovery to market approval takes an average of 8-12 years and costs $800-900 million.
The document provides an overview of the regulatory process for bringing a new drug to market, beginning with pre-clinical studies and submission of an Investigational New Drug (IND) application to the FDA. If approved, the IND allows clinical trials to be conducted in three phases to evaluate safety and efficacy. If phase 3 trials demonstrate a drug is safe and effective, a New Drug Application or Biologics License Application can be submitted for approval to market the drug. Ongoing monitoring of safety continues even after approval.
The document discusses drug design and the drug development process. It describes the two main types of drug design: ligand-based drug design, which relies on knowledge of molecules that bind to the biological target, and structure-based drug design, which models the 3D structure of a protein target. The drug development process involves six main stages: hit identification, pre-clinical studies, manufacturing, clinical trials, regulatory evaluation, and marketing. Overall, drug discovery and development is a complex, expensive process that can take 15 years from initial screening to FDA approval and market launch.
This document provides information about an investigational drug project submitted by Tashi Choezom for her B.Pharmacy degree. It discusses the various phases of drug development including drug discovery, characterization of investigational drugs, formulation, pharmacokinetics, preclinical toxicity studies, the Investigational New Drug application process, bioanalytical and clinical trials. The project is supervised by Kriti Bhadoria and submitted to Veer Madho Singh Bhandari Uttarakhand Technical University.
This document provides an overview of the scope of pharmacology. It discusses the history and evolution of pharmacology from materia medica and early pharmacy to its modern academic, industrial and research applications. Key areas of pharmacology discussed include drug development process, clinical pharmacology, special domains like pharmacovigilance, pharmacoeconomics and emerging areas like pharmacogenomics. The document outlines the past, present and future scope of pharmacology and how it aims to advance human health through rational and safe use of medicines.
Application of bio-pharmaceutics in new drug development .MD SAYDUR RAHMAN
Md. Saydur Rahman presented on the application of biopharmaceutics in new drug development. Biopharmaceutics studies the chemical and physical properties of drugs and their biological effects. Developing new drugs is a long, expensive process involving discovery, pre-clinical testing, clinical trials, and post-approval surveillance. Biopharmaceutics is important throughout this process to understand a drug's absorption, distribution, metabolism, and excretion. Early stages involve finding lead compounds through target identification and validation. Pre-clinical testing assesses toxicity, kinetics, and carcinogenicity in vitro and in vivo before human trials. Clinical trials have three phases to evaluate safety, efficacy, and side effects. Post-marketing surveillance monitors drugs after approval.
This primer is intended for the non-clinician. After reading it, hopefully you will have a slightly better understanding of the complexities of clinical trials.
Discovery of Drug and Introduction to Clinical Trial__Katalyst HLSKatalyst HLS
This document provides an overview of the drug discovery and clinical trials process. It discusses the goals of drug discovery which include identifying new chemical entities and developing medicines to address unmet medical needs. The drug discovery process involves target identification, validation, lead generation, and optimization. Pre-clinical testing is then conducted to evaluate safety and effects. If successful, an investigational new drug application is filed with the FDA prior to beginning clinical trials. Clinical trials involve 4 phases to test safety and efficacy in humans. Upon completion, a new drug application can be filed for FDA review and potential approval.
Discovery of Drug and Introduction to Clinical Trial_Katalyst HLSKatalyst HLS
Introduction to Discovery of Drug and Introduction to Clinical Trials in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
The document provides an overview of the new drug development process, outlining the key steps from discovery and preclinical testing to clinical trials and regulatory approval. It begins with identifying a target and potential drug candidates, then progresses through preclinical screening and safety testing, IND submission, and formal clinical trials in three phases with increasing numbers of participants. The goal is to demonstrate a drug's safety, efficacy, and appropriate dosage before seeking final regulatory review and approval to market the new drug. The entire process from discovery to approval typically takes 10-12 years and costs over $250 million.
Applications of bio-pharmaceutics in new drug deliveryAkshata shettar
Biopharmaceutics plays an integral role in new drug development from discovery through post-approval stages. The development process takes 10-15 years and costs $800 million to $1 billion, involving testing 5000-10000 molecules to find 1 approved drug. Biopharmaceutics evaluates drug properties like absorption, distribution, metabolism, and excretion during discovery and preclinical testing in animals. If successful, drugs then undergo three phases of clinical trials in humans to test for safety, efficacy, and dosage before potential approval and post-marketing surveillance. Biopharmaceutics aims to develop drug formulations and delivery systems that allow for optimal dosing intervals based on a drug's pharmacokinetic profile.
The document discusses regulatory requirements for non-clinical drug development, including guidelines from the European Medicines Agency. It describes the types of non-clinical studies done in silico, in vitro, and in vivo to determine efficacy, safety, delivery methods, and manufacturing viability before clinical trials. Key submissions to regulators include the Investigational New Drug Application, New Drug Application, and Abbreviated New Drug Application.
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
In silico Drug Design: Prospective for Drug Lead Discoveryinventionjournals
International Journal of Engineering and Science Invention (IJESI) is an international journal intended for professionals and researchers in all fields of computer science and electronics. IJESI publishes research articles and reviews within the whole field Engineering Science and Technology, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Pharmaceutical product development and its associated quality system 01Abdirizak Mohammed
Drug development is a long, expensive, and risky process taking 10-15 years. It involves extensive testing of drug candidates in vitro and in animal models to establish safety and efficacy before clinical trials in humans. Clinical trials have three phases - phase I tests safety in healthy volunteers, phase II assesses efficacy and dosing in patients, and phase III confirms safety and efficacy in large patient populations. Only about 1 in 10 drugs that enter clinical trials will be approved due to the high failure rate of drug candidates. Getting a new drug approved is a significant challenge that involves demonstrating safety and efficacy to global regulatory standards.
Drug development - Background informationXplore Health
This guide provides background information on the drug development process including the different phases and the ethical, legal and social aspects associated.
Importance of clinical trials in drug developmentDevanshKarnani2
The pharmaceutical industry is constantly going through rapid growth and progress in creation of new medication and drugs to combat the pandemic and its effects. The pharmaceutical industry is undergoing drastic changes in their methods of production with more and more organisations realising the sheer importance of clinical trials and research and how much it aides them in the development of drugs for disease.
Post marketing surveilance, outsourcing BA and BE to CROJahnabi Sarmah
This document discusses post-marketing surveillance, outsourcing bioavailability and bioequivalence studies to contract research organizations. It provides an introduction to post-marketing surveillance, describing its role in monitoring drug safety after market approval. A brief history is given of pivotal drug safety issues that led to the establishment of formal post-marketing surveillance systems. Common sources of post-marketing information are also outlined. The document defines outsourcing, bioavailability, bioequivalence, and contract research organizations. It explains how outsourcing is used to reduce costs and improve efficiency through utilizing external partners for certain studies and services.
Slides presented by me at the Korean-American Professional Association in Life Sciences (KAPAL) 5th Annual Meeting in Rockville, MD. Slides discuss the recent reorganization of the Center for Drug Evaluation and Research at the FDA
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines
Regulatory authority and organizations are responsible for effective drug regulation required to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public.
Discovery/development Team
Nonclinical pharmacology and toxicology Team
Clinical research Team
Regulatory affairs Team
Marketing Team
Legal Team
Management Team
After the successful completion of clinical research, if the drug candidate proven satisfactory to be safe and effective for its intended use, then drug sponsor can submit New Drug Application (NDA) to respective regulatory authority in order to get marketing license and start commercial production.
Regulatory Affairs is a profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements In-process quality control tests are simply routine checks that are performed during production. They are those tests carried out before manufacturing process is completed to ensure that established product quality is met before they are approved for consumption and marketing.
The function of in-process quality control is monitoring and if necessary adaptation of the manufacturing processes to ensure that the product conforms to its specifications. This may include control of equipment and environment also.
Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are copyrights, patents, trademarks, and trade secrets. The modern concept of intellectual property developed in England in the 17th and 18th centuries. The term "intellectual property began to be used in the 19th century, though it was not until the late 20th century that intellectual property became commonplace in the majority of the world's legal systems. The main purpose of intellectual property law is to encourage the creation of a wide variety of intellectual goods. To achieve this, the law gives people and businesses property rights to the information and intellectual goods they create, usually for a limited period of time. This gives economic incentive for their creation, because it allows people to benefit from the information and intellectual goods they create, and allows them to protect their ideas and prevent copying. These economic incentives are expected to stimulate innovation and contribute to the technological progress of countries, which depends on the extent of protection granted to innovators.
drug industry location and design is considered while designing facility and premises for manufacturing of drug as per the GMP and CGMP regulations. many environmental factores affects safety efficacy and quality of drugs those factores are considerd while designing the manufacturing industry
This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical
Development) section of a regulatory submission in the ICH M4 Common Technical
Document (CTD) format. The Pharmaceutical Development section provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management (for definition, see ICH Q9) to the development of a product and its
manufacturing process. It is first produced for the original marketing application and
can be updated to support new knowledge gained over the lifecycle of a product. The
Pharmaceutical Development section is intended to provide a comprehensive understanding of the product and manufacturing process for reviewers and inspectors. The guideline also indicates areas where the demonstration of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. The degree of regulatory flexibility is predicated on the level of relevant scientific knowledge provided.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. e ICH Q1A guideline and defines the
stability data package for a new drug substance or drug product that is sufficient for
a registration application within the three regions of the EC, Japan, and the United States. It does not seek necessarily to cover the testing for registration in or export to other areas of the world. The guideline seeks to exemplify the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative
approaches can be used when there are scientifically justifiable reasons.
The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records
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NABL is a constituent board of Quality Council of India which is an autonomous body setup under Department for Promotion of Industry and Internal Trade (DPIIT), Ministry of Commerce and Industry, Government of India.
Potentiometry is one of the methods of electroanalytical chemistry. It is usually employed to find the concentration of a solute in solution. In potentiometric measurements, the potential between two electrodes is measured using a high impedance voltmeter An ion-selective electrode (ISE), also known as a specific ion electrode (SIE), is a transducer (or sensor) that converts the activity of a specific ion dissolved in a solution into an electrical potential. There are four main types of ion-selective membrane used in ion-selective electrodes (ISEs): glass, solid state, liquid based, and compound electrode.
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Clinical Research.pptx
1. Principles Of Drug Discovery &
Development
MANSI NARENDRASINH CHAUHAN
M.Pharm
2. Product Development & Technology Transfer
Topic: Principles Of Drug Discovery & Development
Guided by
Dr. Sachin Narkhede &
Mrs. Neha Vadgama
Presented By
MANSI NARENDRASINH CHAUHAN
M.Pharm
Pharmaceutical Quality Assurance
Smt. BNB Swaminarayan Pharmacy College Salvav-Vapi
3. History
• Prior to the 20th century, the discovery of drug substances for the
treatment of human diseases was primarily a matter of “hit or miss”
use in humans, based on folklore and anecdotal reports. Many, if not
most, of our earliest therapeutic remedies were derived from plants
or plant extracts that had been administered to sick humans.
• Pioneers in the field of medicinal chemistry such as Paul Ehrlich,
were instrumental in initiating the transition from the study of plants
or their extracts with purported therapeutic activities to the deliberate
synthesis, in the laboratory, of a specific drug substance.
• Certainly, the discovery of the sulfa drugs in the 1930s added great
momentum to this concept, since they provided one of the earliest
examples of a class of pure chemical compounds that could be
unequivocally shown to reproducibly bring certain infectious
diseases under control when administered to patients by mouth.
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4. 3/28/2022 MANSICHAUHAN-SMTBNBSPCsalvav-vapi 4
• During World War II, the development of penicillin stimulated an
enormous and highly motivated industry aimed at the random
testing of a variety of microbes, This activity was set into motion
by the discovery of Alexander Fleming and others in England in
1929 that a Penicillium mold produced tiny amounts of a substance
that was able to kill various bacteria.
• In addition to the scientific interest in these findings, a major need
existed during World War II for new medications to treat members
of the armed forces.
• Indeed, these efforts resulted in accelerated rates of discovery and
the enormous medical and commercial potential of the antibiotics,
which were evident as early as 1950, assured growth and longevity
to this important new industry. Major pharmaceutical companies
such as Abbott Laboratories, Eli Lilly, E. R. Squibb & Sons, Pfizer
Pharmaceuticals, and The Upjohn Company in the United States.
5. • In the 1960s and 1970s, chemists again came heavily into the
infectious diseases’ arena and began to modify the chemical
structures produced by the microorganisms, giving rise to the so-
called semi-synthetic antibiotics.
• The truly impressive rate of discovery of the ‘semi-synthetic’
antibiotics was made possible by the finding the penicillin and
cephalosporin classes of antibiotics.
• In the later quarter of the 20th century, an exciting new technology
emerged into the pharmaceutical scene, namely, biotechnology.
Using highly sophisticated, biochemical genetic approaches,
significant amounts of proteins, which, prior to the availability of
genetic engineering.
• In the mid- to late 20th century, primarily as a result of the major
screening and chemical synthetic efforts in the pharmaceutical
industry in industrialized countries worldwide, but also as a result
of the biotechnology revolution, increased the need for
sophistication and efficacy.
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6. Introduction
The creation of a new drug can be broadly divided into three main
phases:
Drug discovery – from therapeutic concept to molecule
Drug development – from molecule to registered product
Commercialization – from product to therapeutic application to sales.
• The discovery team, having delivered the first candidate drug, will
carry on looking for others, to serve as back-ups in case the lead
compound should fail in development, or as follow-up compounds
intended to have advantages over the lead compound.
• The three components of the overall process are not independent and
consecutive stages, but have to be closely coordinated at all stages of
the project.
• At the outset of any new project, the criteria against which the plan
will be judged include not only its scientific strength and originality
but, importantly, development and marketing issues.
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8. Drug Discovery
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• Drug discovery can be described as the process of identifying
chemical entities that have the potential to become therapeutic
agents.
• A key goal of drug discovery campaigns is the recognition of new
molecular entities that may be of value in the treatment of diseases
that qualify as presenting unmet medical needs.
• The drug discovery phase of a typical project aimed at producing a
new synthetic drug, starts with the choice of a disease area and
defining the therapeutic need that is to be met.
• It proceeds to the identification of the biochemical, cellular or
pathophysiological mechanism that will be targeted, and, if
possible, the identification and validation of a molecular ‘drug
target’.
• Next comes the identification of a lead structure, followed by the
design, testing and fine tuning of the drug molecule to the point
where it is deemed suitable for development.
10. Drug Development
• Drug development comprises all the activities involved in
transforming a compound from drug candidate (the end-product of
the discovery phase) to a product approved for marketing by the
appropriate regulatory authorities. Efficiency in drug development
is critical for commercial success, for two main reasons:
• Development accounts for about two-thirds of the total R&D costs.
The cost per project is very much greater in the development phase,
and increases sharply as the project moves into the later phases of
clinical development. Keeping these costs under control is a major
concern for management. Failure of a compound late in
development represents a lot of money wasted.
• Speed in development is an important factor in determining sales
revenue, as time spent in development detracts from the period of
patent protection once the drug goes to market. As soon as the
patent expires, generic competition sharply reduces sales revenue.
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11. The Nature of drug development
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Drug discovery, is invariably an exploration of the unknown, and
successful projects may end up with compounds quite different from
what had originally been sought there is a large component of
‘unplannability’. In contrast, drug development has a very clear-cut
goal
• To produce the drug in a marketable form
• To gain regulatory permission to market it for use in the target
indication as quickly as possible.
The work required to do this falls into three main parts,
respectively:
• Technical
• Investigative
• Managerial
12. Technical development:
• Solving technical problems relating to the synthesis and
formulation of the drug substance, aimed mainly at ensuring the
quality of the end-product.
• Main functions involved: chemical development, pharmaceutical
development.
Investigative studies:
• Establishing the safety and efficacy of the product, including
assessment of whether it is pharmacokinetically suitable for clinical
use in man.
• Main functions involved: safety pharmacology, toxicology,
pharmacokinetics, clinical development.
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13. Managerial functions:
• Coordination – managing quality control, logistics,
communication and decision making in a large
multidisciplinary project to ensure high-quality data and
to avoid unnecessary delays:
• Main function involved: project management
• Documentation and liaison with regulatory authorities –
collating and presenting data of the type, quality and
format needed to secure regulatory approval
• Main function involved: regulatory affairs.
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14. Components of drug development
• The components of drug development summarizes the
main activities involved in developing a typical
synthetic compound.
• It shows the main tasks that have to be completed
before the compound can be submitted for regulatory
approval, but needs to be translated into an operational
plan that will allow the project to proceed as quickly
and efficiently as possible.
• It is obvious that certain tasks have to be completed in a
particular order.
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17. Introduction
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• While preclinical research provides answers to basic questions
about a drug’s safety, it is not a substitute for studies of ways the
drug will interact with the human body.
• “Clinical research” refers to studies, or trials, that are done in
people. As the developers design the clinical study, they will
consider what they want to accomplish for each of the different
Clinical Research Phases and begin the Investigational New Drug
Process (IND), a process they must go through before clinical
research begins.
• The clinical development stream is the most complex part of the
drug development process. It also extensively consumes financial
and human resources.
18. Objectives
• The objectives of clinical development of a drug candidate are
to:
1) Study the pharmacological and pharmacokinetic features of
the drug in healthy volunteers and patients,
2) Determine the required dose range and dosing regimen of
the drug to validate its therapeutic efficacy and safety in
targeted population,
3) Study drug-drug and drug-food interactions,
4) Establish a positive benefit-to-risk ratio in patients,
5) Determine the drug's optimal conditions of use in clinical
practice, and
6) Explore new indications, formulations and combinations of
the drug.
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19. Designing clinical trials
Researchers design clinical trials to answer specific research questions
related to a medical product. These trials follow a specific study plan,
called a protocol, that is developed by the researcher or manufacturer.
Before a clinical trial begins, researchers review prior information
about the drug to develop research questions and objectives. Then, they
decide:
• Who qualifies to participate (selection criteria)
• How many people will be part of the study
• How long the study will last
• Whether there will be a control group and other ways to limit research bias
• How the drug will be given to patients and at what dosage
• What assessments will be conducted, when, and what data will be collected
• How the data will be reviewed and analyzed
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20. Clinical research phase studies
• After the preclinical research, the tests and treatments undergo a
series of clinical trials to evaluate if the tests or treatments are safe
and effective for the human subjects. Clinical trials are conducted in
the following five phases:
• 1) Phase 0: The trials of this phase are the first clinical trials
conducted in human subjects. Their objective is to learn the
processes a drug undergoes within the body and the effect it
produces in the body. In these trials, 10 to 15 human subjects are
administered with a very small dose of the drug.
• 2) Phase I: The trials of this phase are conducted to determine that
dose of a new drug which will produce the least side effects. In
these trials, the drug is tested in 15 to 30 patients. The physicians
administer the drug to a few patients in very low doses, and in other
patients the drug is given in high doses till the time either severe
side effects are produced or the desired effect is observed. Phase I
trials are conducted to test whether or not the drug under study is
safe. If it is found to be sufficiently safe, it is processed further for
phase II clinical trial.
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3) Phase II: The trials of this phase evaluate the safety and
effectiveness of the of cancer. These rising new drug The drug is
tested in patients having a specific type of cancer trials are conducted
in a large number of patients using new combinations. Patients are
monitored to check the drug effect, and it found to be effective, it is
processed further for phase III clinical trial.
4) Phase III: The trials of this phase compare a new drug to the
standard care drug being used. These trials are conducted in around
100 or patients to evaluate the side effects of each drug and determine
the do showing better efficacy. These trials are generally randomized,
i.e. patients are randomly put into a treatment group, called trial arms,
using a computer program. Randomization ensures that the people in
all the trio arms are identical. This also allows the scientists to identify
that the clinical trial results are the outcomes of treatment and not the
differences between the groups.
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• Phase III trials can involve more than two treatment groups. The
control group gets the standard-of-care treatment, and the other
groups get a new treatment. Neither the patients nor their physician
can choose the group. The patients will even not know their group
until the trial ends. If the new drug produces severe side effects or
if one group shows much better results, the phase III trial is stopped
early. Phase III clinical trials are conducted before the FDA
approves the use of a new drug for the public.
5) Phase IV: The trials of this phase are conducted to test the FDA-
approved new drugs in several hundreds or thousands of patients.
This allows for better research on short-lived and long-lasting side
effects and safety. In some cases, some rare side effects are only
found in large groups of people. The physicians can also learn about
the drug efficacy alone and when used with other treatments.
23. The Investigational New Drug Process
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• Drug developers, or sponsors, must submit an Investigational New
Drug (IND) application to FDA before beginning clinical
research.
In the IND application, developers must include:
1. Animal study data and toxicity (side effects that cause great
harm) data
2. Manufacturing information
3. Clinical protocols (study plans) for studies to be conducted
4. Data from any prior human research
5. Information about the investigator
24. Asking for FDA Assistance
• Drug developers are free to ask for help from FDA at any point in
the drug development process, including:
1. During the Pre-IND application, to review FDA guidance
documents and get answers to questions that may help enhance
their research
2. After Phase 2, to obtain guidance on the design of large Phase 3
studies
3. Any time during the process, to obtain an assessment of the IND
application
• Even though FDA offers extensive technical assistance, drug
developers are not required to take FDA’s suggestions. As long as
clinical trials are thoughtfully designed, reflect what developers
know about a product, safeguard participants, and otherwise meet
Federal standards, FDA allows wide latitude in clinical trial design.
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25. FDA IND Review Team
The review team consists of a group of specialists in different scientific fields.
Each member has different responsibilities.
Project Manager: Coordinates the team’s activities throughout the review
process, and is the primary contact for the sponsor.
Medical Officer: Reviews all clinical study information and data before,
during, and after the trial is complete.
Statistician: Interprets clinical trial designs and data, and works closely with
the medical officer to evaluate protocols and safety and efficacy data.
Pharmacologist: Reviews preclinical studies.
Pharmakineticist: Focuses on the drug’s absorption, distribution,
metabolism, and excretion processes. Interprets blood-level data at different
time intervals from clinical trials, as a way to assess drug dosages and
administration schedules.
Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was
made and its stability, quality control, continuity, the presence of impurities,
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26. Approval
• The FDA review team has 30 days to review the original IND
submission. The process protects volunteers who participate in
clinical trials from unreasonable and significant risk in clinical
trials. FDA responds to IND applications in one of two ways:
1. The FDA gives Approval to begin clinical trials.
2. The FDA puts a Clinical hold to delay or stop the investigation.
FDA can place a clinical hold for specific reasons, including:
I. Participants are exposed to unreasonable or significant risk.
II. Investigators are not qualified.
III. Materials for the volunteer participants are misleading.
IV. The IND application does not include enough information about
the trial’s risks.
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27. Clinical research protocol
1. General information
2. Background information
3. Study objectives and purpose
4. study design
5. Selection and withdrawal of participant
6. Treatment of participants
7. Assessment of efficacy
8. Assessment of safety
9. Statistics
10. Direct access to source data or documents
11. Quality control and quality assurance
12. Ethics
13. Data management
14. Financing and insurance
15. Publication policy
16. Supplements
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28. References
• Leon Lachman, Herbert A. Liberman, Joseph L. Kaing. (1987). Third edition. “The
theory and practice of industrial pharmacy”. Varghese publishing house. Page no.
966-975.
• Ilango K. D., Shukla V. K., Lakade S. H. (2020). “Industrial pharmacy II”. Thakur
publication PVT. LTD. Page no. 127-135.
• Mann, R.D., Modern Drug Use: “An Enquiry on Historical Principles”, MTP Press,
Lancaster, England, 1984, pp. 1–769.
• G. Smith Charles, James T. O'Donnell. (2006). Second edition. “The Process of New
Drug Discovery and Development”. Informa health care USA Inc. page no. 1-4.
• Raymond G Hill, Humphrey P. Rang. (2013). Second edition. “Drug Discovery and
Development”. Elsevier Ltd. Page no. 123-531.
• www.fda.gov.htm
• www.sciencedirect.com.htm
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