- CROs (Contract Research Organizations) are organizations contracted by pharmaceutical companies to conduct clinical trials and other drug development services. Outsourcing to CROs allows companies to reduce costs and accelerate drug development timelines without requiring large in-house capabilities.
- Key responsibilities of CROs include managing clinical sites and trials, conducting bioanalytical testing, and performing pharmacokinetic analyses. Proper qualification of CROs and ongoing communication are important for successful partnerships. Outsourcing can increase capacity and reduce development cycles for pharmaceutical sponsors.
The document discusses drug product performance and in vitro tests used to evaluate bioavailability and bioequivalence. It defines drug product performance as the release of the drug substance from the product, leading to bioavailability. Approaches discussed to support bioavailability/bioequivalence assessments include in vitro dissolution tests, pharmacodynamic studies, clinical studies, and in vitro-in vivo correlation. The document provides details on using dissolution profiles and similarity factors to evaluate lower strengths and post-approval changes to modified-release formulations.
Outsourcing bioavailability (BA) and bioequivalence (BE) studies to contract research organizations (CROs) is common practice to reduce costs and improve efficiency. When selecting a CRO, companies should thoroughly assess the CRO's clinical trial, bioanalytical, pharmacokinetic, and timeline capabilities. Additionally, companies should qualify proposed clinical sites and bioanalytical laboratories and ensure the CRO can provide final reports and data to regulatory agencies like the FDA as required. Proper CRO selection involves due diligence, competitive bidding, and clearly defining deliverables and report requirements.
pH-activated and Enzyme-activated drug delivery systemSakshiSharma250807
As per the syllabus of M.Pharma (1st sem.) I have presented the topic pH-activated and Enzyme-activated. This comes under rate-controlled drug delivery system under the subject Drug delivery system. Best wishes from Sakshi Sharma
Pharmacovigilance safety Mon. in clinical trials.pptxRoshan Yadav
Pharmacovigilance involves monitoring drug safety and adverse effects during clinical trials. Safety monitoring is critical and requires collaboration between stakeholders like sponsors, investigators, ethics committees, and regulators. Common safety monitoring practices include sponsors developing protocols detailing reporting procedures, investigators collecting data in case report forms, and ethics committees and data safety monitoring boards regularly reviewing accumulating trial data to protect participants.
Investigation of medicinal product dossierDeeptiGupta154
This document discusses the investigation of medicinal product dossiers (IMPDs) which are required for clinical trial approval in the European Union. There are two main steps for drug approval: clinical trial application and marketing authorization application. IMPDs contain information about the investigational medicinal product including protocols, informed consent forms, and risk management plans. IMPDs can be full or simplified depending on previous submissions. An investigator brochure is also required and provides clinical and non-clinical data on the investigational product to investigators. It differs from an IMPD which focuses more on development and manufacturing details.
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
Outsourcing bioavailibility and bioequivalence studies to contract researchGauravchaudhary199
This document defines a contract research organization (CRO) and outlines their goals and services. CROs provide outsourced clinical research services to the pharmaceutical industry. Their services include clinical trials, preclinical research, pharmacovigilance, and biological assay development. Companies outsource to CROs due to lack of in-house capacity, skills, or to control costs. When selecting a CRO, companies should assess their clinical, bioanalytical, and pharmacokinetic capabilities. They should also qualify CRO sites to ensure compliance with Good Clinical Practices and laboratory standards.
The document discusses drug product performance and in vitro tests used to evaluate bioavailability and bioequivalence. It defines drug product performance as the release of the drug substance from the product, leading to bioavailability. Approaches discussed to support bioavailability/bioequivalence assessments include in vitro dissolution tests, pharmacodynamic studies, clinical studies, and in vitro-in vivo correlation. The document provides details on using dissolution profiles and similarity factors to evaluate lower strengths and post-approval changes to modified-release formulations.
Outsourcing bioavailability (BA) and bioequivalence (BE) studies to contract research organizations (CROs) is common practice to reduce costs and improve efficiency. When selecting a CRO, companies should thoroughly assess the CRO's clinical trial, bioanalytical, pharmacokinetic, and timeline capabilities. Additionally, companies should qualify proposed clinical sites and bioanalytical laboratories and ensure the CRO can provide final reports and data to regulatory agencies like the FDA as required. Proper CRO selection involves due diligence, competitive bidding, and clearly defining deliverables and report requirements.
pH-activated and Enzyme-activated drug delivery systemSakshiSharma250807
As per the syllabus of M.Pharma (1st sem.) I have presented the topic pH-activated and Enzyme-activated. This comes under rate-controlled drug delivery system under the subject Drug delivery system. Best wishes from Sakshi Sharma
Pharmacovigilance safety Mon. in clinical trials.pptxRoshan Yadav
Pharmacovigilance involves monitoring drug safety and adverse effects during clinical trials. Safety monitoring is critical and requires collaboration between stakeholders like sponsors, investigators, ethics committees, and regulators. Common safety monitoring practices include sponsors developing protocols detailing reporting procedures, investigators collecting data in case report forms, and ethics committees and data safety monitoring boards regularly reviewing accumulating trial data to protect participants.
Investigation of medicinal product dossierDeeptiGupta154
This document discusses the investigation of medicinal product dossiers (IMPDs) which are required for clinical trial approval in the European Union. There are two main steps for drug approval: clinical trial application and marketing authorization application. IMPDs contain information about the investigational medicinal product including protocols, informed consent forms, and risk management plans. IMPDs can be full or simplified depending on previous submissions. An investigator brochure is also required and provides clinical and non-clinical data on the investigational product to investigators. It differs from an IMPD which focuses more on development and manufacturing details.
Investigational medical product dossierSachinFartade
Investigational medical product dossier is document made to apply for clinical trial application in European Union. European Medical Agency is regulatory body for drug approval in European Union.
Outsourcing bioavailibility and bioequivalence studies to contract researchGauravchaudhary199
This document defines a contract research organization (CRO) and outlines their goals and services. CROs provide outsourced clinical research services to the pharmaceutical industry. Their services include clinical trials, preclinical research, pharmacovigilance, and biological assay development. Companies outsource to CROs due to lack of in-house capacity, skills, or to control costs. When selecting a CRO, companies should assess their clinical, bioanalytical, and pharmacokinetic capabilities. They should also qualify CRO sites to ensure compliance with Good Clinical Practices and laboratory standards.
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
ATUL CHAUDHARY (STUDENTS)
DEPARTMENT OF PHARMACEUTICS
ISF COLLEGE OF PHARMACY, GHALKALAN, MOGA , PUNJAB
THIS SLIDE IS THE BEST SLIDE FOR PREPARING THE TOPIC SUPAC OF REGULATORY AFFAIRS SUBJECT
SLIDE ARE SPECIALLY DESIGN FOR MASTER STUDENTS AS WELL AS GRADUATION STUDENTS
Sustained and controlled release drug delivery systemParul Sharma
This document discusses sustained and controlled release drug delivery systems (SR and CRDDS). It defines SR and CRDDS and lists their advantages and disadvantages. It describes factors that influence the release rate from these systems, including physicochemical factors like solubility and biological factors like metabolism. The document outlines various physicochemical approaches to SR and CRDDS like matrix systems, reservoir systems, and ion exchange systems. It also discusses biological approaches using biopolymers and pulsatile release formulations. Finally, it briefly mentions applications and concludes with references.
The document discusses the abbreviated new drug application (ANDA) regulatory approval process for generic drugs in the United States. It describes the key steps and reviewing bodies involved, including filing review by the Regulatory Support Branch, coordination of reviews by bioequivalence, chemistry, and labeling teams, and final approval. The primary goal of the ANDA process is to determine if the generic drug is bioequivalent to the reference listed drug while ensuring safety and manufacturing quality standards are met.
This document discusses the non-clinical drug development process. It begins with an introduction explaining that developing new drugs requires expertise from many disciplines and takes 10-12 years and over $800 million on average. It then discusses the Investigational New Drug (IND) application process, which allows clinical trials in humans after pre-clinical studies in animals. It describes the types of INDs and provides charts outlining the IND and New Drug Application (NDA) processes. Finally, it briefly discusses the Abbreviated New Drug Application (ANDA) process for generic drugs.
IN VIVO AND SCALE-UP PROCESS APPROVAL CHANGES.pptxPawanDhamala1
The document discusses in vivo and scale-up process approval changes. It defines in vivo as experiments done on living organisms. SUPAC guidelines provide regulatory guidance for scale-up batches and post-approval changes. Changes are categorized as minor, major, or moderate. Level 1 changes have minimal impact while Level 3 changes likely impact quality. Requirements include chemistry documentation, dissolution testing, and bioequivalence studies depending on the level of change. Site, batch size, equipment, and process changes are also discussed along with associated testing requirements.
This document discusses three types of triggered drug delivery systems: bioerosion regulated, bioresponsive, and self-regulating. Bioerosion regulated systems use an immobilized enzyme on the surface of a polymer matrix to increase pH and degrade the polymer in the presence of a triggering agent. Bioresponsive systems control drug permeability through a bioresponsive membrane based on local biochemical concentrations. Self-regulating systems use competitive binding within a polymer encapsulated reservoir to activate drug release when triggered by a membrane permeable agent. Examples of insulin delivery are provided for the bioresponsive and self-regulating systems.
The document discusses various aspects of interacting with the FDA, including their missions, divisions, and processes for industry communication and drug approval. It outlines the FDA's roles in inspections, legal sanctions, scientific expertise, and product safety. It also describes methods for industry liaisons such as meetings, advisory committees, and Freedom of Information Act requests. The goal is to provide knowledge on planning effective interactions and navigating the drug approval process.
The document discusses the requirements and contents of an Investigational Medicinal Product Dossier (IMPD) which provides information on the quality, manufacture, and control of investigational medical products (IMPs) used in clinical trials in the European Union. An IMPD includes summaries of nonclinical and clinical data and is required for authorization to perform clinical trials in EU member states. It must provide an overall risk-benefit assessment of the proposed trial based on nonclinical and clinical analyses. A simplified IMPD may be acceptable in some cases such as if the IMP is already authorized. The IMPD covers quality data, nonclinical pharmacology and toxicology data, previous clinical experience, and an overall risk assessment.
Investigation of medicinal product dossier (IMPD)Himal Barakoti
The document discusses the Investigational Medicinal Product Dossier (IMPD) which contains detailed information on the quality, manufacture, and control of investigational medicinal products tested in clinical trials within the European Union. The IMPD is submitted as part of clinical trial authorization applications to regulatory authorities. It includes summaries of non-clinical and clinical data and a risk-benefit assessment. The IMPD requirements are harmonized across EU member states under regulations established by the European Medicines Agency to facilitate multinational clinical trials.
This document provides an overview of bioequivalence and drug product assessment. It defines key terms like bioequivalence and pharmaceutical equivalence. It discusses the need for and types of bioequivalence studies. The document outlines the objectives and statistical evaluation of bioequivalence data. It also describes different study designs like randomized crossover designs and factors to consider like food effects. Furthermore, it discusses the types of evidence required to establish bioequivalence and conditions for biowaivers.
Regulatory requirements of eu & mhra trilokTrilok Shahare
The document summarizes the regulatory requirements of the European Union (EU) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The EU established the European Medicines Agency (EMA) which is responsible for scientific evaluation and safety monitoring of medicines. EMA grants marketing authorization after assessment and plays an important role in regulating medicines across EU. The MHRA regulates medicines and medical devices in the UK to ensure safety, quality and efficacy. It oversees clinical trials, manufacturing licensing, and post-marketing surveillance.
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.
This document outlines 10 key regulatory requirements for conducting clinical trials in India. It defines what constitutes a new drug and clinical trial. It discusses the need for ethics committee approval and registration, informed consent, reporting of adverse events, and compensation for injuries. The document emphasizes that clinical sites must be prepared for inspection and certain non-drug intervention studies still require ethics approval and registration. Overall, it provides an overview of the regulatory framework and responsibilities for investigators conducting clinical research in India.
Theories of dispersion, pharmaceutical dispersion (Emulsion and suspension).pptxDipeshGamare
In this presentation Theories of dispersion, pharmaceutical dispersion (Emulsion and suspension) with their mechanism, methods of preparation and stability studies are mentioned.
Regulatory requirement of EU, MHRA and TGAHimal Barakoti
The document summarizes regulatory requirements for medicines in the European Union, United Kingdom, Australia, and other countries. The European Medicines Agency regulates medicines for the EU and ensures they are safe, effective and high quality. Medicines must receive market authorization from the EMA or national authorities before sale. The UK's Medicines and Healthcare Products Regulatory Agency regulates clinical trials and product licensing. Australia's Therapeutic Goods Administration ensures medicines available there meet quality, safety and efficacy standards.
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
ATUL CHAUDHARY (STUDENTS)
DEPARTMENT OF PHARMACEUTICS
ISF COLLEGE OF PHARMACY, GHALKALAN, MOGA , PUNJAB
THIS SLIDE IS THE BEST SLIDE FOR PREPARING THE TOPIC SUPAC OF REGULATORY AFFAIRS SUBJECT
SLIDE ARE SPECIALLY DESIGN FOR MASTER STUDENTS AS WELL AS GRADUATION STUDENTS
Sustained and controlled release drug delivery systemParul Sharma
This document discusses sustained and controlled release drug delivery systems (SR and CRDDS). It defines SR and CRDDS and lists their advantages and disadvantages. It describes factors that influence the release rate from these systems, including physicochemical factors like solubility and biological factors like metabolism. The document outlines various physicochemical approaches to SR and CRDDS like matrix systems, reservoir systems, and ion exchange systems. It also discusses biological approaches using biopolymers and pulsatile release formulations. Finally, it briefly mentions applications and concludes with references.
The document discusses the abbreviated new drug application (ANDA) regulatory approval process for generic drugs in the United States. It describes the key steps and reviewing bodies involved, including filing review by the Regulatory Support Branch, coordination of reviews by bioequivalence, chemistry, and labeling teams, and final approval. The primary goal of the ANDA process is to determine if the generic drug is bioequivalent to the reference listed drug while ensuring safety and manufacturing quality standards are met.
This document discusses the non-clinical drug development process. It begins with an introduction explaining that developing new drugs requires expertise from many disciplines and takes 10-12 years and over $800 million on average. It then discusses the Investigational New Drug (IND) application process, which allows clinical trials in humans after pre-clinical studies in animals. It describes the types of INDs and provides charts outlining the IND and New Drug Application (NDA) processes. Finally, it briefly discusses the Abbreviated New Drug Application (ANDA) process for generic drugs.
IN VIVO AND SCALE-UP PROCESS APPROVAL CHANGES.pptxPawanDhamala1
The document discusses in vivo and scale-up process approval changes. It defines in vivo as experiments done on living organisms. SUPAC guidelines provide regulatory guidance for scale-up batches and post-approval changes. Changes are categorized as minor, major, or moderate. Level 1 changes have minimal impact while Level 3 changes likely impact quality. Requirements include chemistry documentation, dissolution testing, and bioequivalence studies depending on the level of change. Site, batch size, equipment, and process changes are also discussed along with associated testing requirements.
This document discusses three types of triggered drug delivery systems: bioerosion regulated, bioresponsive, and self-regulating. Bioerosion regulated systems use an immobilized enzyme on the surface of a polymer matrix to increase pH and degrade the polymer in the presence of a triggering agent. Bioresponsive systems control drug permeability through a bioresponsive membrane based on local biochemical concentrations. Self-regulating systems use competitive binding within a polymer encapsulated reservoir to activate drug release when triggered by a membrane permeable agent. Examples of insulin delivery are provided for the bioresponsive and self-regulating systems.
The document discusses various aspects of interacting with the FDA, including their missions, divisions, and processes for industry communication and drug approval. It outlines the FDA's roles in inspections, legal sanctions, scientific expertise, and product safety. It also describes methods for industry liaisons such as meetings, advisory committees, and Freedom of Information Act requests. The goal is to provide knowledge on planning effective interactions and navigating the drug approval process.
The document discusses the requirements and contents of an Investigational Medicinal Product Dossier (IMPD) which provides information on the quality, manufacture, and control of investigational medical products (IMPs) used in clinical trials in the European Union. An IMPD includes summaries of nonclinical and clinical data and is required for authorization to perform clinical trials in EU member states. It must provide an overall risk-benefit assessment of the proposed trial based on nonclinical and clinical analyses. A simplified IMPD may be acceptable in some cases such as if the IMP is already authorized. The IMPD covers quality data, nonclinical pharmacology and toxicology data, previous clinical experience, and an overall risk assessment.
Investigation of medicinal product dossier (IMPD)Himal Barakoti
The document discusses the Investigational Medicinal Product Dossier (IMPD) which contains detailed information on the quality, manufacture, and control of investigational medicinal products tested in clinical trials within the European Union. The IMPD is submitted as part of clinical trial authorization applications to regulatory authorities. It includes summaries of non-clinical and clinical data and a risk-benefit assessment. The IMPD requirements are harmonized across EU member states under regulations established by the European Medicines Agency to facilitate multinational clinical trials.
This document provides an overview of bioequivalence and drug product assessment. It defines key terms like bioequivalence and pharmaceutical equivalence. It discusses the need for and types of bioequivalence studies. The document outlines the objectives and statistical evaluation of bioequivalence data. It also describes different study designs like randomized crossover designs and factors to consider like food effects. Furthermore, it discusses the types of evidence required to establish bioequivalence and conditions for biowaivers.
Regulatory requirements of eu & mhra trilokTrilok Shahare
The document summarizes the regulatory requirements of the European Union (EU) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The EU established the European Medicines Agency (EMA) which is responsible for scientific evaluation and safety monitoring of medicines. EMA grants marketing authorization after assessment and plays an important role in regulating medicines across EU. The MHRA regulates medicines and medical devices in the UK to ensure safety, quality and efficacy. It oversees clinical trials, manufacturing licensing, and post-marketing surveillance.
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.
This document outlines 10 key regulatory requirements for conducting clinical trials in India. It defines what constitutes a new drug and clinical trial. It discusses the need for ethics committee approval and registration, informed consent, reporting of adverse events, and compensation for injuries. The document emphasizes that clinical sites must be prepared for inspection and certain non-drug intervention studies still require ethics approval and registration. Overall, it provides an overview of the regulatory framework and responsibilities for investigators conducting clinical research in India.
Theories of dispersion, pharmaceutical dispersion (Emulsion and suspension).pptxDipeshGamare
In this presentation Theories of dispersion, pharmaceutical dispersion (Emulsion and suspension) with their mechanism, methods of preparation and stability studies are mentioned.
Regulatory requirement of EU, MHRA and TGAHimal Barakoti
The document summarizes regulatory requirements for medicines in the European Union, United Kingdom, Australia, and other countries. The European Medicines Agency regulates medicines for the EU and ensures they are safe, effective and high quality. Medicines must receive market authorization from the EMA or national authorities before sale. The UK's Medicines and Healthcare Products Regulatory Agency regulates clinical trials and product licensing. Australia's Therapeutic Goods Administration ensures medicines available there meet quality, safety and efficacy standards.
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
Objectives , policies and principles of cGMP guidelines in pharmaceutical ind...JaskiranKaur72
The presentation contains detailed information about the current GMP in the pharmaceutical industry. It has objectives , policies and principles of cGMP guidelines.
Pdf file is being attached in the link below- https://drive.google.com/file/d/11al8n8AqrkUR_Vnm-z4Mp6O0elzyniEz/view?usp=drivesdk
This document discusses outsourcing bioavailability and bioequivalence studies to contract research organizations (CROs). It defines key terms like bioavailability, bioequivalence, and CROs. It outlines reasons for outsourcing like reducing costs and improving efficient resources. It describes assessing CRO capabilities in clinical work, bioanalytics, pharmacokinetics, and timelines. It discusses qualifying CROs through due diligence, clinical and bioanalytical site visits, and assessing final report contents and processes like protocol development, clinical conduct, and bioanalytical work. The document provides an overview of outsourcing clinical research to CROs.
OUTSOURCING BIOAVAILABILITY AND BIOEQUIVALENCE TO CROKushal Saha
The document discusses outsourcing bioavailability (BA) and bioequivalence (BE) studies to contract research organizations (CROs). Outsourcing such studies is common for smaller pharmaceutical companies and generic drug companies that lack internal clinical and bioanalytical capabilities. When selecting a CRO, companies should qualify the CRO's clinical, bioanalytical, and pharmacokinetic capabilities to ensure compliance with good practices. The document provides details on evaluating a CRO's facilities, personnel, validation procedures, and ability to coordinate different stages of BA and BE studies.
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
The document summarizes the strategic outsourcing of clinical trials to contract research organizations (CROs) with a focus on India and China as growing markets. It discusses the reasons for outsourcing clinical trials, including rising costs and complexity. CROs provide expertise and services to sponsors at lower costs than sponsors conducting all research internally. India and China offer lower costs than Western countries and have large patient populations and clinical trial infrastructure to support outsourced research. Both countries have seen significant growth in their CRO industries in recent years.
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.
Outsourcing of Regulatory Affairs Tasks in PharmaceuticalAnu Gummerus
The document summarizes a study on the outsourcing of regulatory affairs tasks in the pharmaceutical industry in Europe. The key findings are:
1) The most commonly outsourced regulatory task was translation of product information texts (75% of respondents).
2) The main reason for outsourcing regulatory affairs tasks to Contract Research Organizations (CROs) was the heavy workload in companies' regulatory departments. Ensuring outsourcing is cost-effective was also a key factor.
3) When choosing a CRO partner, companies valued the CRO's experience and knowledge most highly. Personal contacts with the CRO were also often mentioned as important in selecting a partner.
Clinical Research Org. Intensifies Compliance by Automating Audit & CAPA MetricStream Inc
This document describes a leading clinical research organization that wanted to enhance its compliance and quality management. It was manually conducting audit and corrective action processes using spreadsheets, which led to inefficiencies. It implemented the MetricStream solution to automate audit management and corrective action planning. This streamlined processes, provided better visibility and reporting, and helped ensure compliance with various regulations. The automated solution reduced cycle times and audit costs while improving precision and productivity.
OUTSOURCING TO BE AND BA final (1).pptxDhanaa Dhoni
This document discusses outsourcing bioavailability and bioequivalence studies to contract research organizations (CROs). It covers key considerations for identifying an appropriate CRO, including assessing their clinical, bioanalytical, and pharmacokinetic capabilities. The document also discusses important factors for qualifying CRO clinical and bioanalytical sites, such as personnel qualifications and compliance with good clinical and laboratory practices. Additionally, it addresses protocol development, clinical study population selection, laboratory tests, dose and safety considerations, and bioanalytical method validation.
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
International Pharmaceutical Industry: Feasibility Is Not (Anymore) A Plain S...KCR
Investigational Sites
The sole term ‘feasibility’ has multiple definitions in a clinical environment, leading to certain bias with all stakeholders involved, including pharma companies (sponsors) and all types of contract research organizations (CROs). The most common perception is related to a never-ending argument between pharma outsourcing departments and CRO commercial groups, with sponsors expecting CROs to run a (non-defined) feasibility study prior to proposal submission and CROs undertaking a series of schematic actions to create an impression of fulfilled expectation.
Contract Research Organisations- CRO in Pharma FieldVINOTH R
The document provides an overview of contract research organizations (CROs). It discusses that CROs were originally formed to help pharmaceutical companies deal with capacity issues and excess demand. CROs now provide a wide range of clinical trial and drug development services to pharmaceutical sponsors. They have become an important partner for both large pharmaceutical firms and smaller biotech companies. However, the Indian CRO industry still faces challenges such as financial issues, a lack of accredited trial sites, and regulatory hurdles.
Role of CRO’s in Medical Innovation and Drug DevelopmentJohn Douglas
Critical medical conditions such as new threats from chronic diseases and their debilitating conditions require quick responses and consistent attempts on a global level. Therefore, when the medical equipment and pharmaceutical biotechnology companies are in need to introduce efficient and effective drugs faster to the market, that is the time when they also need partners who are able to collaborate and assure them effortless development and service delivery.
This document provides information about an upcoming conference on managing partnerships with contract research organizations (CROs). The conference will take place on October 3-4, 2012 in London and will include presentations from pharmaceutical companies and CROs on trends in clinical development outsourcing, developing effective CRO partnerships, and managing regulatory inspections of CRO activities. Pre-conference workshops on October 2 will focus on defining the scope of CRO relationships and ensuring quality in CRO engagements. Key speakers are listed from pharmaceutical companies like Pfizer, Eli Lilly and AstraZeneca and CROs like Quintiles. The document outlines the conference agenda and encourages those in clinical development, outsourcing, and related areas to attend.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
ICON is a contract research organization that provides outsourcing services to pharmaceutical, biotechnology, and medical device companies. ICON has expanded into foreign markets through acquisitions of AptivSolutions and Niphix, which position it for growth in Asia and Europe. ICON has also partnered with IBM to utilize IBM's Watson HealthCloud for data storage and analytics, giving ICON a competitive advantage over other CROs. ICON offers a full scope of clinical trial services, from drug development through FDA approval, attracting large pharmaceutical clients.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Kat...rightmanforbloodline
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
TEST BANK For Basic and Clinical Pharmacology, 14th Edition by Bertram G. Katzung, Verified Chapters 1 - 66, Complete Newest Version.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
3. INTRODUCTION
Sponsors +company
A CRO (Contact Research Organization is an organization )contracted by another company to manage
and lead the company’s trials, duties and functions.
CRO provide much needed service to the pharmaceutical sector.
These organizations provide the service necessary for the approval of new clinical entities or generic
drug product.
CRO’s provide the services such as clinical or analytical studies.
Many of the pharmaceutical companies have in house capabilities and many of them don’t have these
capabilities .in that time pharmaceutical company are required to outsource their clinical trails, including
BA&BE studies
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Contract
CR
O
Manage
companies
trails or duties
4. • Outsourcing reduces the time to conduct a trial v/s doing the trail in house ad that
translates to significant cost savings
• A contract with an outside company means that the hiring organization does not need
the infrastructure, office space or manpower to run these trials themselves.
• Some CRO manage almost all aspects of a clinical trail, from the site selection to final
regulatory approval from the FDA and EMA
• But the sponsor remain responsible for the integrity of the trail data and to ensure it is
all supported by good science.
• It is critical that the CRO and client should realise the importance of seamless
communication between them.
• This collaboration is necessary to achieve study success in timely manner.
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5. KEY ELEMENTS FOR THE SUCCESS
1. Communication at all level between the CRO and pharmaceutical
company.
2. Sensitivity to both the project specific requirements and timelines
3. Flexibility to recognize and adjust to unexpected events throughout the
project timeline
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6. DEFINITIONS
Outsourcing
is the business practice of hiring a party outside a company to perform service
and create goods that traditionally were performed in house by the company’s
own employee and staff.
Outsourcing is generally done to reduce the cost and improve the efficient
resource within a company.
CRO (Contract Research Organizations)
CRO is an organization that provide support to the pharmaceutical,
biotechnological and medical deceives industry in the form of research services
outsourced on a contract basis.
It offers various pharmaceutical research that is essential for the conducting
clinical trails, the ICH technical requirements for registration of pharmaceuticals
for human use
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7. OUT SOURCING
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pharmaceutical companies are trying to cut costs and speed up the drug
discovery process either by acquiring other companies and thus overcoming
the lack of expertise and knowledge and/or by outsourcing part of their
activities.
Skills or activities that are needed rarely or for a short period of time are better
outsourced than developed in-house, thereby lowering the cost.
The task of the outsourcing specialist is to support the goals of programs and
projects by facilitating collaboration with outsourcing providers.
One of the main reasons for outsourcing is the downward cost pressure
exerted on the pharmaceutical manufacturer’s profit margins.
Given that these cost pressure may continue to increase in the future, CRO are
becoming more important strategic partner for pharmaceutical companies.
8. KEY REASONS FOR OUTSOURCING
Capabilities out side company facilities/operations
Specialised facilities/operations needed
Accelerate drug development
Reduce time to market.
Production capacity exceeded or fluctuates with seasonal demand
Greater return on investment
Maximize the patient life by decreasing time to initiate clinical studies.
Flexibility and ability to respond to changing developmental requirements
based on marketing and clinical response.
Support uncertain product approvals without tying up internal resources.
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9. CRO( CONTRACT RESEARCH ORGANIZATION )
A CRO is an organization that provides support to the pharmaceutical ,
biotechnological and medical device industries in the form of research services
outsourced on a contract basis.
Working with CRO’s entry in to drug development has become immensely simplified
as the need for large pharma companies to do everything in house is now reductant.
CROs also supports foundations , research institutions and universities in additions to
governmental organizations such as NIH, EMA etc.
They are more mistakeproof well experienced professionals, that offers preclinical ,
clinical, and regulatory activities for drug development ad commercialization.
CROs consists of classes of full service , multinational ,publicity trade firms.
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10. CRO QUALIFICATION
Due diligence
If the pharmaceutical firm has used the CRO in the past, they should
objectively evaluate their past experience with CRO
if the experience was good the firm should identify those components that
were successful and insure they are used for their new study.
However ,caution should be exercised and due diligence pursued ,if the new
study requires a different subject population or analytical technique.
Eg:
A CRO may specialize in recruiting healthy male and female volunteers but
may have difficulty in recruiting postmenopausal females.
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11. Clinical site qualification/Audits
The sponsor should conduct a site qualification visit. In addition to good clinical
practice (GCP) site audits , this evaluation should include the assessment of the areas
such as
a. Clinical site evaluation
Assess the volunteer population pool
Evaluate CRO procedures for AE investigator
Assess training records
b. Clinical data management
Assess the validation of data collection system
c. Evaluation of clinical deliverables
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12. Bio analytical site qualification
Candidate CROs for bioanalytical laboratory work should also be assessed.
The personnel and their qualifications and analytical methods and validation
should be assessed before awarding the study.
The company audit should also include cGLP compliance and an assessment of
the laboratory’s inspection history
Pharmacokinetic site qualification
The pharmaceutical firm should also qualify the CRO site that is responsible for
p/k and statistical analyses and completion of the final integrated report.
The group should have all programs fully validated according to the FDA
programming guidelines.
During p/k site audit the following area should be carefully assessed
• Qualification of p/k and statistical personnel.
• Validation of p/k and statistical program (usually SAS)
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13. ROLE OF CRO IN INDUSTRY
The principal role the CRO is to contribute to enhancement of financial
performance of its customer.
Improvement efficacy of their clients product development activities provide
benefits to regulators, physicians and their patients.
CRO may also play a role in developing safety profile in large patient population
that are exposed to a new product after its approved .
The development required for approval of a new medication is lengthy,
expensive,risky,and subject to govt regulations.
in current price- sensitive environment which is the hall mark of modern
healthcare and certainty New Drug Development, expenses necessary to support
clinical research are major concern for sponsors.
As the product development cost are expected to grow a significant element
influencing pharmaceutical pricing , the role of innovative CRO is expected to
grow.
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14. Major benefits of using CRO
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Increased
external
capacity
• Provide significant additional man power
• Provide support in areas of legal issues , regulatory requirements,
pricing, and change order procedure
Reduced
cycle time
• Shortening the time to market
• Involving large scale out patient clinical trails
• Engaging in the full spectrum of services of the pharmaceutical industry
Accelerating
the learning
curve
• Small companies with limited experience in clinical research can
benefit significant from the experiences of CRO having good
performance in that area
15. CONTRACTOR SELECTION
A SOP must define the process, requirements and responsibilities for the selection
,evaluation and approval of contractor.
Considerations for selecting a contractor
Reputation
Regulatory inspection history, both domestic and international.
Finance stability
Broad client base, supported by several years.
Ability to meet and manage timelines.
Strong communicator
Sufficient staffing and equipment to perform a specific work.
Reliability
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16. Preparedness to build and maintain a strong and lasting business relationship.
Complete understanding and commitment to quality.
Ability to provide a wide selection of technologies for specific non sterile
product requirements.
Personnel with proven experience in technology and management/co-
ordination
Potential to provide international shipment through partnership or other
facilities of the company.
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17. OVERALL OUTSOURCING PROCESS FOR A
FINISHED PRODUCT
Client Contractor
Quality ,business and legal agreements information
data.
Communication
Regular meetings
Monitoring agreement requirements
Build :
Confidence
Business relationships
Reliability
Accountability
certification
Certificate analysis
Certificate of compliance
Process out put ;product filing etc.
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18. CONCLUSION
• Client needs contractor to meet their company goals for increased producṭivity
and above all for marketing a profit.
• Clients are responsible for ensuring that the contractor has a clear
understanding of the scope and content of the project .
• Contractors are responsible for working with their clients to understand their
specific requirements.
• Contractor have multiple clients pulling them in many different direction at
the same time.
• Communication is at the centre of all the projects and the responsibilities of
both parties.
• Be open with the contractor and they will in turn want to keep an opean
rapport with clients.
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19. REFENCES
1. Good manufacturing practices for pharmaceuticals sixth edition by
Joseph D Nally
2. The process of New Drug Discovery and development 2nd edition by
Charles,G. Smith .
3. Generic drug product development by Leon Shargel Pg:265-277
4. Slide share
5. Google
6. HTTPS://WWW.RESEARCHGATE.NET/PUBLICATION/27186458_O
UTSOURCING_IN_PHARMACEUTICAL_RESEARCH_AND_DEVEL
OPMENT_OPPORTUNITIES_AND_CHALLENGES
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