An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
Investigational New Drug Application enabling studies.pptxNikitaBankoti2
The document provides information on Investigational New Drug (IND) applications. It defines an IND as a submission to the FDA requesting permission to study an investigational drug product in humans. Key points include:
- An IND application contains preclinical and clinical data to demonstrate it is reasonably safe to study the drug in humans.
- It allows the sponsor to initiate and conduct clinical trials of the investigational drug.
- The IND application process helps ensure the safety of clinical trial subjects and that clinical studies will yield valid results to determine a drug's safety and effectiveness.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
The document summarizes the process for obtaining an Investigational New Drug Application (IND) from the FDA to conduct clinical trials of an experimental drug. It outlines what is included in an IND submission such as preclinical data, clinical protocols, manufacturing information, and previous human experience. It also describes the FDA review process and requirements for annual reports during the clinical trial period. The overall goal of an IND is to demonstrate an experimental drug's safety for initial testing in humans while obtaining approval to conduct clinical research.
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...Audumbar Mali
The document provides information on the regulatory approval process for drugs. It discusses the various stages of approval including investigational new drug applications (IND), new drug applications (NDA), and abbreviated new drug applications (ANDA).
The stages include pre-clinical testing, clinical trials through multiple phases, and regulatory review and approval. An IND must be approved by the FDA before clinical trials in humans can begin. If clinical trials are successful, manufacturers can file an NDA to request approval to market the drug. For generic drugs, an ANDA can be filed to demonstrate bioequivalence to an existing approved drug, without needing to re-conduct clinical trials. The approval process is complex and lengthy, usually taking 10-
The document discusses the purpose and requirements of an Investigational New Drug (IND) application submitted to the FDA. An IND allows a company to ship an experimental drug and conduct clinical trials in humans. It provides safety data and details of planned trials for FDA review to ensure risks are minimized for subjects. A complete IND includes chemistry, manufacturing, pharmacology, protocols and other application materials for FDA evaluation before trials may begin.
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans.
An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
Investigational New Drug Application enabling studies.pptxNikitaBankoti2
The document provides information on Investigational New Drug (IND) applications. It defines an IND as a submission to the FDA requesting permission to study an investigational drug product in humans. Key points include:
- An IND application contains preclinical and clinical data to demonstrate it is reasonably safe to study the drug in humans.
- It allows the sponsor to initiate and conduct clinical trials of the investigational drug.
- The IND application process helps ensure the safety of clinical trial subjects and that clinical studies will yield valid results to determine a drug's safety and effectiveness.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
This document provides an overview of the Investigational New Drug (IND) application process. It discusses how an IND is required to begin clinical trials on new drugs and allows pharmaceuticals to be transported between states for research purposes. The document outlines the various stages of pre-clinical and clinical testing, including pre-clinical studies in animals to establish safety, and the three phases of human clinical trials. It provides details on the key components of an IND application, including chemistry and manufacturing information, clinical protocols, and safety data from non-clinical studies. The overall goal of an IND is to obtain permission from the FDA to begin human clinical trials by demonstrating the new drug and trial design will not place subjects at unreasonable risk.
The document summarizes the process for obtaining an Investigational New Drug Application (IND) from the FDA to conduct clinical trials of an experimental drug. It outlines what is included in an IND submission such as preclinical data, clinical protocols, manufacturing information, and previous human experience. It also describes the FDA review process and requirements for annual reports during the clinical trial period. The overall goal of an IND is to demonstrate an experimental drug's safety for initial testing in humans while obtaining approval to conduct clinical research.
BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)2. unit ii, chapter-1 reg...Audumbar Mali
The document provides information on the regulatory approval process for drugs. It discusses the various stages of approval including investigational new drug applications (IND), new drug applications (NDA), and abbreviated new drug applications (ANDA).
The stages include pre-clinical testing, clinical trials through multiple phases, and regulatory review and approval. An IND must be approved by the FDA before clinical trials in humans can begin. If clinical trials are successful, manufacturers can file an NDA to request approval to market the drug. For generic drugs, an ANDA can be filed to demonstrate bioequivalence to an existing approved drug, without needing to re-conduct clinical trials. The approval process is complex and lengthy, usually taking 10-
The document discusses the purpose and requirements of an Investigational New Drug (IND) application submitted to the FDA. An IND allows a company to ship an experimental drug and conduct clinical trials in humans. It provides safety data and details of planned trials for FDA review to ensure risks are minimized for subjects. A complete IND includes chemistry, manufacturing, pharmacology, protocols and other application materials for FDA evaluation before trials may begin.
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans
1. An Investigational New Drug (IND) application is required for testing an experimental drug in humans and must be submitted to regulatory agencies like the FDA for approval.
2. The IND application contains preclinical research data on animal and microbiological studies as well as clinical trial protocols, manufacturing information, and investigator details.
3. There are different types of INDs including commercial, non-commercial, emergency use, and treatment INDs which have varying requirements and purposes in the drug development process.
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.
The document discusses the investigational new drug (IND) application process. It defines an IND as an application that allows sponsors to legally conduct clinical trials of investigational drugs in humans. The IND process involves preclinical animal testing, filing an INDA application including information on manufacturing and clinical protocols, a 30-day review period by the FDA, and oversight of clinical trials and reporting if approved. It provides details on the various sections, forms, classifications and reviews involved in the IND application and approval process.
Non-clinical contract research organizations (CROs) have become an integral part of drug discovery and development to support sponsors research needs, expedite timelines and provide an extension of technical and scientific support.
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.
The document discusses the Investigational New Drug (IND) application process with the FDA. An IND application allows a company to ship an experimental drug across state lines and begin clinical trials. It must include preclinical data to show the drug is safe for initial human use as well as protocols for proposed studies. The FDA reviews the IND for 30 days before clinical trials may begin to ensure subject safety. The overall goal of an IND is to facilitate testing of new drugs while protecting clinical trial participants.
Investigational new drug application newAakrati Gupta
The document provides an overview of Investigational New Drug (IND) applications submitted to the FDA when conducting clinical trials of new drug products. An IND is required before any clinical testing of an unapproved drug can begin and allows the sponsor to ship the drug across state lines for research purposes. The document outlines the content and format of an IND application, including a cover sheet, introductory statement, investigational plan, clinical protocol, chemistry/manufacturing data, and previous human experience. It also discusses FDA review of INDs and annual reporting requirements.
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval for human clinical trials of an experimental drug. An IND application includes preclinical animal data, manufacturing information, and clinical trial protocols. It allows 30 days for FDA review to ensure the trials will not expose subjects to unreasonable risks. The FDA reviews INDs from medical, chemistry, pharmacology and statistical perspectives and can notify the sponsor of deficiencies. Clinical trials can then proceed unless a clinical hold is issued.
An Investigational New Drug (IND) application allows a sponsor to lawfully use an investigational drug for clinical investigation purposes. It provides information on preclinical testing, clinical protocols, manufacturing, and investigator qualifications to ensure subject safety. An IND is required for clinical studies intended to support a new indication, change in dosage/administration, or different patient population. It exempts the sponsor from prohibitions on shipping unapproved drugs and facilitates three phases of clinical trials to evaluate safety and efficacy.
The document discusses the Investigational New Drug (IND) application process. An IND application is required for a pharmaceutical company to conduct clinical trials of an unapproved drug and ship the drug across state lines. The IND application contains information on preclinical animal and toxicology studies, clinical trial protocols, manufacturing details, and the qualifications of investigators. It must be approved by the FDA before clinical trials can begin.
An IND application is submitted to the FDA to request permission to conduct clinical trials on an investigational new drug. It contains preclinical animal and toxicity data, manufacturing information, and clinical trial protocols and investigator information. The FDA reviews the IND over 30 days to ensure the protection of human subjects and that the investigational plan allows for evaluation of safety and effectiveness. Clinical trials cannot begin until the IND is approved or the 30-day review period has ended without FDA objection. Sponsors must submit annual reports updating the FDA on the progress of investigations under the IND.
The document provides an overview of non-clinical drug development processes. It discusses the key stages including Investigational New Drug (IND) applications which allow clinical trials in humans after pre-clinical studies in animals. It then covers New Drug Applications (NDA) which are required for marketing approval after Phase III trials, and Abbreviated New Drug Applications (ANDA) which are required for generic drugs to demonstrate bioequivalence rather than new clinical trials. The development process aims to discover and develop new drugs safely and cost over $800 million on average.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
The document provides an overview of non-clinical drug development processes. It discusses the key stages including Investigational New Drug (IND) application, New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational Medicinal Product Dossier (IMPD), and Investigator Brochure (IB). The stages involve extensive pre-clinical and clinical testing in animals and humans to evaluate safety and efficacy before regulatory approval and marketing of new drugs.
The document discusses the key aspects of an Investigational New Drug (IND) application submitted to the FDA to request permission to conduct clinical trials of an unapproved drug. An IND application contains information on the drug's chemistry, manufacturing, pharmacological and toxicological effects, clinical protocol, and investigators brochure. It allows the FDA to ensure the risks to human subjects are reasonable. The FDA reviews INDs within 30 days to determine if a clinical hold is needed before trials can begin. Annual reports updating trial progress are also required.
The document provides information on Investigational New Drug (IND) enabling studies and the IND application process. Some key points:
- An IND application is required to ship an experimental drug across state lines for clinical trials before marketing approval. The FDA reviews the IND for safety.
- An IND application contains information on animal studies, chemistry/manufacturing, and clinical trial protocols. It must demonstrate the drug is reasonably safe for initial human testing.
- An IND application must follow specific guidelines, including summaries of pharmacology/toxicology studies, chemistry/manufacturing details, clinical protocols, and responsibilities of investigators and sponsors. It allows the drug to enter Phase I clinical trials upon
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval to begin human clinical trials of an experimental drug. An IND application includes preclinical animal data, clinical trial protocols, and information about manufacturing. The FDA has 30 days to review an IND for safety before trials may begin. Clinical holds may be placed on applications that pose unreasonable risks or are missing required information. Notifications are provided to sponsors regarding review outcomes and any deficiencies that must be addressed.
The document discusses the processes of investigational new drug (IND) application and new drug application (NDA).
The IND process allows testing of new drugs in humans to demonstrate safety and effectiveness prior to marketing. An NDA provides evidence of a drug's safety, effectiveness and quality for regulatory approval to market.
Developing a new drug takes an average of 15 years and huge costs. The IND contains pre-clinical data while the NDA has complete clinical trial results to prove a drug's risks outweigh its benefits and that its labeling and manufacturing are adequate. Regulatory agencies thoroughly review both applications to ensure a drug's quality and protect human subjects.
Niosome An Non-Ionic Surfactant Vesicles.pptxPrachi Pandey
Niosomes are nanosized vesicles composed of nonionic surfactants and cholesterol that form when these compounds are dispersed in an aqueous medium. These lipid-based structures are similar to liposomes but differ in their composition, as niosomes use nonionic surfactants instead of phospholipids. The unique characteristic of niosomes lies in their ability to encapsulate both hydrophilic and hydrophobic drugs within their bilayer membrane. This feature makes them promising candidates for drug delivery systems, as they can protect the encapsulated drug from degradation, prolong its release, and enhance its bioavailability. Additionally, niosomes offer advantages such as biocompatibility, stability, and ease of preparation, making them a versatile platform for targeted drug delivery and other biomedical applications.
Niosomes (Formulation and evaluation).pptxPrachi Pandey
Niosomes are a novel drug delivery system that encapsulates the medication in a vesicular system made up of non ionic surfactants.
The vesicle is made up of a bilayer of non-ionic surfactants, thus the name niosomes.
Niosomes are extremely small and microscopic (on a nanometric scale).
Despite having a similar structure to liposomes, they have several advantages over them.
Niosomes are biocompatible, nonimmunogenic, and biodegradable in nature and exhibit flexibility in their structured characterization
Based on the vesicle size, niosomes can be divided into three groups.
Small unilamellar vesicles (SUV, size=0.025-0.05 μm),
Multilamellar vesicles (MLV, size=>0.05 μm), and
Large unilamellar vesicles (LUV, size=>0.10 μm).
In the formulation of niosomes, the selection of surfactants is based on hydrophilic-lipophilic balance (HLB) value. HLB values between 4 and 8 recommended for the facile formation of niosomes and surfactants with an HLB value of more than 8 are required to optimize cholesterol concentration.
However, it has been widely observed that HLB value between 4 and 8 is highly recommended for better encapsulation efficiency, of niosomes. For example, long stearyl and short lauryl chain length increase and decrease the entrapment efficiency of niosomes, respectively.
Long hydrophilic chains result in increased encapsulation of hydrophilic drugs, and long hydrophobic chains result in improved encapsulation of lipophilic drugs.
Long Hydrophilic Chains and Increased Encapsulation of Hydrophilic Drugs:
Surfactants with longer hydrophilic chains create larger aqueous compartments within the niosome bilayer. This provides more space for water-soluble drugs to reside, leading to higher encapsulation efficiency.
Example: Span 60 (HLB 4.7) has a longer hydrophilic chain compared to Span 20 (HLB 8.6). Studies have shown that using Span 60 in niosomes resulted in significantly higher encapsulation efficiency of the hydrophilic drug gentamicin, compared to formulations using Span 20.
Long Hydrophobic Chains and Improved Encapsulation of Lipophilic Drugs:
Long hydrophobic chains increase the affinity of the niosome bilayer for lipid-soluble drugs. These drugs can partition and entrap themselves within the bilayer structure, leading to improved encapsulation.
Example: Tween 80 (HLB 15) has a longer hydrophobic chain compared to Tween 20 (HLB 16.7). Niosomes prepared with Tween 80 demonstrated superior encapsulation of the lipophilic drug curcumin compared to those made with Tween 20.
Pegylation is a process where polyethylene glycol (PEG), a biocompatible and hydrophilic polymer, is attached to the surface of niosomes. This modification offers several advantages for drug delivery:
Benefits of Pegylation:
Increased Stability: PEG creates a steric barrier, preventing proteins and other molecules in the blood from adhering to the niosome surface. This reduces aggregation and opsonization (recognition by immune cells).
An Investigational New Drug Application (IND) is a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans
1. An Investigational New Drug (IND) application is required for testing an experimental drug in humans and must be submitted to regulatory agencies like the FDA for approval.
2. The IND application contains preclinical research data on animal and microbiological studies as well as clinical trial protocols, manufacturing information, and investigator details.
3. There are different types of INDs including commercial, non-commercial, emergency use, and treatment INDs which have varying requirements and purposes in the drug development process.
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.
The document discusses the investigational new drug (IND) application process. It defines an IND as an application that allows sponsors to legally conduct clinical trials of investigational drugs in humans. The IND process involves preclinical animal testing, filing an INDA application including information on manufacturing and clinical protocols, a 30-day review period by the FDA, and oversight of clinical trials and reporting if approved. It provides details on the various sections, forms, classifications and reviews involved in the IND application and approval process.
Non-clinical contract research organizations (CROs) have become an integral part of drug discovery and development to support sponsors research needs, expedite timelines and provide an extension of technical and scientific support.
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.
The document discusses the Investigational New Drug (IND) application process with the FDA. An IND application allows a company to ship an experimental drug across state lines and begin clinical trials. It must include preclinical data to show the drug is safe for initial human use as well as protocols for proposed studies. The FDA reviews the IND for 30 days before clinical trials may begin to ensure subject safety. The overall goal of an IND is to facilitate testing of new drugs while protecting clinical trial participants.
Investigational new drug application newAakrati Gupta
The document provides an overview of Investigational New Drug (IND) applications submitted to the FDA when conducting clinical trials of new drug products. An IND is required before any clinical testing of an unapproved drug can begin and allows the sponsor to ship the drug across state lines for research purposes. The document outlines the content and format of an IND application, including a cover sheet, introductory statement, investigational plan, clinical protocol, chemistry/manufacturing data, and previous human experience. It also discusses FDA review of INDs and annual reporting requirements.
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval for human clinical trials of an experimental drug. An IND application includes preclinical animal data, manufacturing information, and clinical trial protocols. It allows 30 days for FDA review to ensure the trials will not expose subjects to unreasonable risks. The FDA reviews INDs from medical, chemistry, pharmacology and statistical perspectives and can notify the sponsor of deficiencies. Clinical trials can then proceed unless a clinical hold is issued.
An Investigational New Drug (IND) application allows a sponsor to lawfully use an investigational drug for clinical investigation purposes. It provides information on preclinical testing, clinical protocols, manufacturing, and investigator qualifications to ensure subject safety. An IND is required for clinical studies intended to support a new indication, change in dosage/administration, or different patient population. It exempts the sponsor from prohibitions on shipping unapproved drugs and facilitates three phases of clinical trials to evaluate safety and efficacy.
The document discusses the Investigational New Drug (IND) application process. An IND application is required for a pharmaceutical company to conduct clinical trials of an unapproved drug and ship the drug across state lines. The IND application contains information on preclinical animal and toxicology studies, clinical trial protocols, manufacturing details, and the qualifications of investigators. It must be approved by the FDA before clinical trials can begin.
An IND application is submitted to the FDA to request permission to conduct clinical trials on an investigational new drug. It contains preclinical animal and toxicity data, manufacturing information, and clinical trial protocols and investigator information. The FDA reviews the IND over 30 days to ensure the protection of human subjects and that the investigational plan allows for evaluation of safety and effectiveness. Clinical trials cannot begin until the IND is approved or the 30-day review period has ended without FDA objection. Sponsors must submit annual reports updating the FDA on the progress of investigations under the IND.
The document provides an overview of non-clinical drug development processes. It discusses the key stages including Investigational New Drug (IND) applications which allow clinical trials in humans after pre-clinical studies in animals. It then covers New Drug Applications (NDA) which are required for marketing approval after Phase III trials, and Abbreviated New Drug Applications (ANDA) which are required for generic drugs to demonstrate bioequivalence rather than new clinical trials. The development process aims to discover and develop new drugs safely and cost over $800 million on average.
Investigational new drug application must be submitted after discovering a new drug and before beginning of clinical trials. Here given a brief note on the topic.The topics included are types of IND, criteria for application, Information in IND application, resources for IND application, laws.regulations, policies and procedures, IND forms and instructions, IND content requirements and review of IND
The document provides an overview of non-clinical drug development processes. It discusses the key stages including Investigational New Drug (IND) application, New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational Medicinal Product Dossier (IMPD), and Investigator Brochure (IB). The stages involve extensive pre-clinical and clinical testing in animals and humans to evaluate safety and efficacy before regulatory approval and marketing of new drugs.
The document discusses the key aspects of an Investigational New Drug (IND) application submitted to the FDA to request permission to conduct clinical trials of an unapproved drug. An IND application contains information on the drug's chemistry, manufacturing, pharmacological and toxicological effects, clinical protocol, and investigators brochure. It allows the FDA to ensure the risks to human subjects are reasonable. The FDA reviews INDs within 30 days to determine if a clinical hold is needed before trials can begin. Annual reports updating trial progress are also required.
The document provides information on Investigational New Drug (IND) enabling studies and the IND application process. Some key points:
- An IND application is required to ship an experimental drug across state lines for clinical trials before marketing approval. The FDA reviews the IND for safety.
- An IND application contains information on animal studies, chemistry/manufacturing, and clinical trial protocols. It must demonstrate the drug is reasonably safe for initial human testing.
- An IND application must follow specific guidelines, including summaries of pharmacology/toxicology studies, chemistry/manufacturing details, clinical protocols, and responsibilities of investigators and sponsors. It allows the drug to enter Phase I clinical trials upon
The document discusses Investigational New Drug (IND) applications, which are submitted to the FDA to obtain approval to begin human clinical trials of an experimental drug. An IND application includes preclinical animal data, clinical trial protocols, and information about manufacturing. The FDA has 30 days to review an IND for safety before trials may begin. Clinical holds may be placed on applications that pose unreasonable risks or are missing required information. Notifications are provided to sponsors regarding review outcomes and any deficiencies that must be addressed.
The document discusses the processes of investigational new drug (IND) application and new drug application (NDA).
The IND process allows testing of new drugs in humans to demonstrate safety and effectiveness prior to marketing. An NDA provides evidence of a drug's safety, effectiveness and quality for regulatory approval to market.
Developing a new drug takes an average of 15 years and huge costs. The IND contains pre-clinical data while the NDA has complete clinical trial results to prove a drug's risks outweigh its benefits and that its labeling and manufacturing are adequate. Regulatory agencies thoroughly review both applications to ensure a drug's quality and protect human subjects.
Niosome An Non-Ionic Surfactant Vesicles.pptxPrachi Pandey
Niosomes are nanosized vesicles composed of nonionic surfactants and cholesterol that form when these compounds are dispersed in an aqueous medium. These lipid-based structures are similar to liposomes but differ in their composition, as niosomes use nonionic surfactants instead of phospholipids. The unique characteristic of niosomes lies in their ability to encapsulate both hydrophilic and hydrophobic drugs within their bilayer membrane. This feature makes them promising candidates for drug delivery systems, as they can protect the encapsulated drug from degradation, prolong its release, and enhance its bioavailability. Additionally, niosomes offer advantages such as biocompatibility, stability, and ease of preparation, making them a versatile platform for targeted drug delivery and other biomedical applications.
Niosomes (Formulation and evaluation).pptxPrachi Pandey
Niosomes are a novel drug delivery system that encapsulates the medication in a vesicular system made up of non ionic surfactants.
The vesicle is made up of a bilayer of non-ionic surfactants, thus the name niosomes.
Niosomes are extremely small and microscopic (on a nanometric scale).
Despite having a similar structure to liposomes, they have several advantages over them.
Niosomes are biocompatible, nonimmunogenic, and biodegradable in nature and exhibit flexibility in their structured characterization
Based on the vesicle size, niosomes can be divided into three groups.
Small unilamellar vesicles (SUV, size=0.025-0.05 μm),
Multilamellar vesicles (MLV, size=>0.05 μm), and
Large unilamellar vesicles (LUV, size=>0.10 μm).
In the formulation of niosomes, the selection of surfactants is based on hydrophilic-lipophilic balance (HLB) value. HLB values between 4 and 8 recommended for the facile formation of niosomes and surfactants with an HLB value of more than 8 are required to optimize cholesterol concentration.
However, it has been widely observed that HLB value between 4 and 8 is highly recommended for better encapsulation efficiency, of niosomes. For example, long stearyl and short lauryl chain length increase and decrease the entrapment efficiency of niosomes, respectively.
Long hydrophilic chains result in increased encapsulation of hydrophilic drugs, and long hydrophobic chains result in improved encapsulation of lipophilic drugs.
Long Hydrophilic Chains and Increased Encapsulation of Hydrophilic Drugs:
Surfactants with longer hydrophilic chains create larger aqueous compartments within the niosome bilayer. This provides more space for water-soluble drugs to reside, leading to higher encapsulation efficiency.
Example: Span 60 (HLB 4.7) has a longer hydrophilic chain compared to Span 20 (HLB 8.6). Studies have shown that using Span 60 in niosomes resulted in significantly higher encapsulation efficiency of the hydrophilic drug gentamicin, compared to formulations using Span 20.
Long Hydrophobic Chains and Improved Encapsulation of Lipophilic Drugs:
Long hydrophobic chains increase the affinity of the niosome bilayer for lipid-soluble drugs. These drugs can partition and entrap themselves within the bilayer structure, leading to improved encapsulation.
Example: Tween 80 (HLB 15) has a longer hydrophobic chain compared to Tween 20 (HLB 16.7). Niosomes prepared with Tween 80 demonstrated superior encapsulation of the lipophilic drug curcumin compared to those made with Tween 20.
Pegylation is a process where polyethylene glycol (PEG), a biocompatible and hydrophilic polymer, is attached to the surface of niosomes. This modification offers several advantages for drug delivery:
Benefits of Pegylation:
Increased Stability: PEG creates a steric barrier, preventing proteins and other molecules in the blood from adhering to the niosome surface. This reduces aggregation and opsonization (recognition by immune cells).
Non-ionic surfactant vesicles, commonly referred to as niosomes, have garnered significant attention within the pharmaceutical industry due to their remarkable capacity to encapsulate both hydrophilic and hydrophobic drugs. Recent studies have demonstrated the potential of these vesicles to enhance the bioavailability of drugs, making them a promising strategy for delivering various therapeutic agents such as gene materials, protein therapeutics, and chemical pharmaceuticals. This approach offers minimal toxicity and desirable targeting effectiveness. Niosomes are substantially more stable during the preparation and storage procedure than liposomes. The desired pharmacokinetics property can be attained through the optimization of constituents or surface modifications. This novel method of distribution is also facile to establish and expand, while maintaining cost-effective manufacturing expenses. This review article elucidates the fundamentals of niosomes as non-ionic surfactant vesicles, including their structure and components, as well as various formulation methods. Additionally, the article explores the diverse applications of niosomal in the analgesics.
The Application of Response Surface Methodology (RSM) In the Computational Op...Prachi Pandey
Introduction: This study explores the use of Response Surface Methodology (RSM), a statistical optimization technique, to optimize the SR properties of prochlorperazine maleate (PCM) matrix tablets. PCM is a phenothiazine derivative used for treating schizophrenia, nausea, and vomiting. Sustained-release formulations offer extended drug delivery, potentially improving patient compliance and reducing side effects. RSM helps identify optimal combinations of critical formulation factors influencing drug release, such as polymer type and concentration, filler type, and drug/polymer ratio. The study likely involves designing experiments based on chosen RSM designs (e.g., Box-Behnken) with varying factor levels. Formulate SR tablets with different factor combinations. Evaluating the drug release profiles of each tablet formulation. Analyzing data using RSM software to build mathematical models relating factors to drug release and identifying optimal factor combinations that maximize desired release characteristics.
Objective: The ongoing research purpose to improve the advancement of a sustained release tablet containing Phenothiazine derivative PCM loaded matrix. This is achieved by utilizing DoE as a computational method to statistically validate the formulation.
The Utilization of 32 Full Factorial Design (FFD) for Optimization of Linco...Prachi Pandey
Objectives: The ongoing research aims to enhance the development of LNH-loaded nanogel by
utilizing DoE as the computational method to statistically validate their formulation.
Methodology: In this research Chitosan used as a natural polymer and Poly (Ethylene glycol)
[PEG] as a penetration or permeation enhancer. The different nanogel of LNH were synthesized
using the Nanoprecipitation and Dispersion method, with variations in the drug-polymer ratio
(1/0.03, 1/0.08, 1/0.12). The process parameters were carefully optimizing for enhance the
efficiency of the synthesis. To achieve this, optimization studies were conducted using 3² FFD,
employing the Design Expert Software Trial version 10.0.7. The total of 13 runs were generated to
ensure comprehensive analysis and evaluation of the procedure. The selected independent
variables included the concentration of Chitosan (R1) and Carbopol 934 (R2). The dependent
variables, on the other hand, were particle size (P1), Polydispersity Index (P2), and % Drug release
(P3), chosen in that order. By employing this optimization technique, one can acquire valuable
information in a manner that is both efficient and cost-effective. This approach facilitates a deeper
comprehension of the relationship between controllable independent variables and the performance
and quality of the Nanogels being produced
Determination of Partition coefficient of Known and Unknown drug.pdfPrachi Pandey
Partition coefficient, often denoted as P or P_oct, is a measure of how a solute distributes between two immiscible (unmixable) solvents. It is commonly used in chemistry, biochemistry, and pharmacology to understand the distribution of a compound between different phases, such as between a hydrophobic organic solvent and water. In experimental settings, the partition coefficient is determined by measuring the concentrations of the solute in each phase. The values obtained provide insights into the solute's behavior and can guide decisions in various scientific and industrial processes.
Pharmaceutical Suspension Dosage Form (PPT)Prachi Pandey
A pharmaceutical suspension is a heterogeneous system in which finely divided solid particles are dispersed in a liquid medium. Unlike solutions, where solutes are completely dissolved, suspensions involve particles that are only partially soluble or insoluble in the liquid. These suspensions are commonly used in the pharmaceutical industry to deliver medications that may be poorly soluble or unstable in their pure form. The solid particles, often in the form of powders or crystals, are dispersed throughout the liquid phase, creating a stable mixture through the use of suspending agents or stabilizers. These agents prevent the settling of particles, ensuring uniform distribution and ease of redispersion upon shaking before administration. Pharmaceutical suspensions offer advantages in terms of flexibility in dosing and formulation, enabling the delivery of therapeutic agents in various forms such as oral liquids, injectables, or topical preparations, enhancing patient compliance and therapeutic efficacy. The formulation and stability of pharmaceutical suspensions require careful consideration of factors such as particle size, density, and the choice of stabilizers to maintain a consistent and reliable product.
Suppositories and pessaries are both types of medication delivery systems that are designed to be inserted into body orifices for therapeutic purposes. While they serve similar functions, they are used in different parts of the body.
Suppositories:
Usage: Suppositories are typically designed for rectal or vaginal administration.
Composition: They are solid, bullet-shaped or cone-shaped dosage forms that contain medication in a base that melts or dissolves at body temperature.
Rectal Suppositories: Commonly used for medications that need to bypass the digestive system or when a patient cannot take medications orally. They are inserted into the rectum.
Vaginal Suppositories: Often used for localized treatment of gynecological conditions, such as yeast infections or hormonal therapy. They are inserted into the vagina.
Pessaries:
Usage: Pessaries are specifically designed for vaginal administration.
Composition: They are solid, oval-shaped or ring-shaped devices made of various materials such as silicone, rubber, or plastic.
Indications: Pessaries are mainly used to support the uterus, bladder, or rectum in cases of pelvic organ prolapse. However, they can also be used for the controlled release of medication into the vagina for the treatment of local conditions.
Maintenance: Pessaries need to be fitted by a healthcare professional and should be cleaned and reinserted regularly.
Partition coefficients are a fascinating and important concept in many fields, from chemistry and environmental science to medicine and pharmacology. They tell us about how a substance will distribute itself between two immiscible phases, like how a drug might move between your blood and tissues, or how a pollutant might spread through soil and water.
A partition coefficient, denoted as P or log P, describes the ratio of the concentration of a compound in one phase (usually organic) to its concentration in another phase (often water) at equilibrium.
Higher values of P indicate a greater preference for the organic phase, meaning the compound is more lipophilic (fat-loving).
Lower values of P suggest a higher affinity for the aqueous phase, implying the compound is more hydrophilic (water-loving).
Research Methodology_UNIT_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)Prachi Pandey
Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
Research Methodology_UNIT_I_General Research Methodology M. Pharm (IIIrd Sem.)Prachi Pandey
General Research Methodology: Research, objective, requirements, practical
difficulties, review of literature, study design, types of studies, strategies to eliminate
errors/bias, controls, randomization, crossover design, placebo, blinding techniques.
THE CURRENT STATUS IN MUCOSALDRUG DELIVERY SYSTEM (MDDS)AND FUTURE PROSPECTUS...Prachi Pandey
This systematic review aims to provide a comprehensive overview of the current status of mucosal drug delivery systems (MDDS) and explore their future prospects in drug delivery. MDDS have gained significant attention in recent years due to their potential to enhance drug absorption, improve therapeutic efficacy, and minimize systemic side effects. This review critically evaluates the existing literature on MDDS, including various mucosal routes such as oral, nasal, ocular, pulmonary, and vaginal delivery. Additionally, it discusses the challenges associated with MDDS, such as formulation development, stability, and regulatory considerations. Furthermore, this review highlights emerging technologies and innovative strategies that hold promise for the future of MDDS. Overall, this systematic review provides valuable insights into the current landscape of MDDS and offers recommendations for future research and development in this field.
Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Lab...Prachi Pandey
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of disease, personal
hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and
training, transport of lab animals.
This document discusses product management, material management, inventory management, and control in the pharmaceutical industry. It defines key terms like CGMP, material management, inventory classification, and inventory control techniques. The objectives of inventory management are to avoid stockouts and shortages while minimizing costs. Techniques like ABC analysis, VED analysis, EOQ, perpetual inventory, and buffer stock are described for effective inventory control. The roles and responsibilities of pharmacists in drug procurement are also outlined.
The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General at CDSCO. Drug and Cosmetic Act 1945: It Contains provisions for classification of drugs under given schedules. Guidelines for the storage,sale,display and prescription of each schedule.
Microspheres are small spherical particles, with diameter 1 µm to 1000 µm.
They are spherical free flowing particles consisting of proteins or synthetic polymers which are biodegradable in nature.
PROTEINS: Proteins are the large organic compounds made of amino acids arranged in a linear chain and joined together by peptide bonds.
Protein > 50 amino acids
PEPTIDES: These are short polymers formed from the linking, in a defined order of amino acids.
Peptide < 50 amino acids
Three-dimensional (3-D) printing is elevating various growth in production viewpoint both at nanoscale and macro-scales. 3-D printing is being scouted for numerous bio-pharmaceutical administration and creation of nano-medicines employing supplementary production methods and shows assurance in capability in satisfying the demands for a patient-based customized approach. The previous outcome features the accessibility of novel natural bio-materials and finely designed polymeric substances, which can be created as unique 3-D printed nano-materials for numerous bio-pharmaceutical administrations as nano-medicines. Nano-medicine is described as the utilization of nanoscience in fabricating nano-materials for various pharmaceutical utilization, comprising identification, cure, scan, stopping, and management of diseases. Nano-medicine has also displayed a huge effect in the creation and evolve an accurate drug. In contrary the "one-size-fits-all" benchmark for the traditional drug is a personalized, structured, or accurate drug considering the variation in numerous characteristics, comprising genetics and pharmacokinetics of various victims, which have exhibited better outcomes over traditional cures. This article highlights the approaches advancements in the design and development of customized-made nano-medicine employing 3-D printing science.
TOTAL QUALITY MANAGEMENT, BUDGET & COST CONTROL.pptxPrachi Pandey
Definition: TQM has been defined as an integrated organization effort designed to improve quality at every level.
“ The process to produce a perfect product by a series of measures require an organized effort by the entire company to prevent or eliminate errors at every stage in production is called Total Quality Management (TQM).”
The Aim of TQM is “Prevention of defect rather than detection on defect.”
TQM is very important for pharmaceutical industries to produce the better product and ensure the maximum safety of health care system and also protect waste of money for both government and individual customer.
The word pharmacy is derived from the Greek word “Pharmakon”, meaning medicine or drug. In other term, “Pharmacy may defined as the art and science of preparing (manufacturing) and dispensing of drugs prepared by the natural and synthetic sources and using for the treatment as well as prevention of diseases”. In general sense, it is the place where medicine or drugs are sold. Pharmacy is a health profession that links health science with chemical science and aims to ensure the safe and effective use of pharmaceutical drugs. It includes the collection, identification, synthesis, purification, isolation and quality control of medical substance or pharmaceutical products.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
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International FDP on Fundamentals of Research in Social Sciences
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it describes the bony anatomy including the femoral head , acetabulum, labrum . also discusses the capsule , ligaments . muscle that act on the hip joint and the range of motion are outlined. factors affecting hip joint stability and weight transmission through the joint are summarized.
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
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This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
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Reimagining Your Library Space: How to Increase the Vibes in Your Library No ...Diana Rendina
Librarians are leading the way in creating future-ready citizens – now we need to update our spaces to match. In this session, attendees will get inspiration for transforming their library spaces. You’ll learn how to survey students and patrons, create a focus group, and use design thinking to brainstorm ideas for your space. We’ll discuss budget friendly ways to change your space as well as how to find funding. No matter where you’re at, you’ll find ideas for reimagining your space in this session.
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UP
GLOBAL SUBMISSION ON IND.pptx
1. GLOBAL SUBMISSION ON IND
PRACHI PANDEY*
RAHUL PAL
M. PHARM (PHARMACEUTICS)
NIMS INSTITUTE OF PHARMACY, NIMS UNIVERSITY, JAIPUR, RAJASTHAN, INDIA.
2. CONTENTS
INVESTIGATIONAL NEW DRUG APPLICATION (IND)
• INTRODUCTION
DO & DON’T
• TYPES OF IND STUDIES
IND CONTENT AND FORMAT
• IND SUBMISSION PROCESS
QUESTIONAR
3. INVESTIGATIONAL NEW DRUG
APPLICATION (IND)
An Investigational New Drug is a submission to Food and Drug Administration
(FDA) requesting permission to initiate the study of New drug products.
The IND is also the vehicle through which a sponsor advances to the next stage of drug
development known as clinical trials (human trials).
Investigational new drug defined under 21 CRF 312.3 (b) “as a new drug or biological
drug that is used in clinical investigation.
4. INTRODUCTION
Definition: “An Investigational New Drug Application (IND) is a request from a
clinical study sponsor to obtain authorization from the Food and Drug
Administration (FDA) to administer an investigational drug or biological product to
humans.”
• IND application is used to provide data showing is reasonable to begin test of a new
drug on humans.
• Sponsor investigator is means an individual who both initiate and conducts an
investigation.
5. WHEN DO WE NEED AS
IND
An IND is require at any time when we
want to conduct a clinical trial of an
unapproved drug.
An IND would be required to conduct a
clinical trial if the drug is:
◦ A new chemically entity, not approved
for the indication under investigation in
a new dosage form.
◦ Being administered at a new dosage
level.
WHEN DO DON’T NEED AN
IND
An IND is not required to conduct a study
if the drug:
◦ Is not intended for human subjects, but
is intended for vivo testing or lab
research (non-clinical studies).
◦ Is an approved drug and the study is
within its approved indication for use.
6. TYPES OF IND STUDIES
All clinical studies where a new dug is administered to human subjects, regardless of whether the drug
will be commercially developed, require an IND.
01. Investigator IND: Submitted by a physician who both initiates and conducts an investigation, and
under whose immediate direction the investigational drug is administered or dispensed.
02. Emergency IND: All the FDA to authorize use of an experimental drug in an emergency situation.
03. Treatment IND: Is submitted for experimental drug promise in clinical testing of serious or
immediately life-threatening conditions while the final clinical work is conducted and the FDA review
takes place.
7. CLASSIFICATION OF IND
Commercial: Permits sponsor to collect data on clinical safety and effectiveness
needed for application for marketing in the form of NDA.
Research (Non-Commercial): Permit the sponsor to use drug in research to
obtain advanced scientific knowledge of new drug and plan to market the
product.
8. IMPORTANCE OF IND
Helps in the result of successful preclinical development program.
The preclinical study, helps the sponsor’s primary goal to determine that the products
is reasonably safe for initiate use in human.
It is important for the company to initiate and conduct the clinical studies of their new
product.
It secure the safety and effectiveness of the clinical trials subjects.
IND can be alternative in a life threatening situation when no standard acceptable
therapy is available.
9. IND CONTENT & FORMAT
Cover sheet (FORM FDA 1571)
Table of contents.
Introductory statement and general investigational plan.
Investigator's brochure.
Protocols.
Chemistry, Manufacturing and Control information (CMC).
Pharmacology and toxicology information.
Previous human experience with the investigational drug.
Other relevant information like no of IND submission, no. of copies to be submitted (1+2)
Protocol amendments, any changes in the protocol.
10. TABLE OF CONTENT
Table of content-
• Comprehensive listing of contents of IND
application broken in volumes and page
number.
TOC include- Sections, appendices,
attachments, repots and other reference
material.
A well drafted TOC will facilitate the task
of review and decrease the review time.
GENERAL INVESTIGATIONAL
PLAN
A brief 3 to 4 pages notes on-
- The investigational products
- Sponsors investigational plan.
Goal of the section is to-
◦ To provide brief description of the
drug.
◦ Layout development plan of the
drug.
11. INVESTIGATORS BROCHURE
Key development provided to each
investigator and IRB at each of the clinical
site.
◦ Includes- All about the investigational drug.
IB is a living documents and must be
updated by the sponsor.
PROTOCOLS
Describes how the clinical trial would be
conducted.
It describes-
- The objectives of the study.
- How subjects would be selected.
- How the trial is to be conducted.
12. IND SUBMISSION PROCESS
All Collected data should be submitted in triplicate to the FDA alongside three
supplementary forms.
◦ The FDA then has 30 days to review and approve your product. In the case of
approval, or simply a lack of rejection in the 30-day timeframe, your product has
the green light to progress to the clinical testing stage and may be transported to
clinical investigators in different states.
14. How long does it take to get IND
approval?
- After submission of IND to the FDA, it is assigned to the various divisions of
Centre for Drug Research and Evaluation wing of the FDA for its review and
evaluation.
- Once the IND is submitted, the sponsor must wait 30 calendar days before
initiating any clinical trials. During this time, FDA has an opportunity to review
the IND for safety to assure that research subjects will not be subjected to
unreasonable risk.
15. WHO GAVE APPROVAL FOR IND?
The office of DCG (I) grants approval of manufacture / import of new drugs for
marketing in the country. This office is also responsible for grant of permission to
conduct clinical trials of new drugs including Investigational New Drugs (IND).
16. What comes first IND or NDA ?
The difference between IND and NDA
- It starts with an IND submission (after the pre-clinical activities are settled to
gain approval to cross state lines and start clinical trials) and ends with the NDA
submission to ensure all aspects of the drug are effective and ready to market in the USA.