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Like this presentation? Why not share! Investigational new drug applicatio Embed Size px. Start on. Show related SlideShares at end. WordPress Shortcode. Published in: Education. Full Name Comment goes here. Are you sure you want to Yes No. Veena Kanabur. Karthiga M , Doctor at Doctor at Doctor. Krithika Krithika. Chandrasekhar Chemarthi. Show More.

No Downloads. Views Total views. Actions Shares. Embeds 0 No embeds. No notes for slide. Indian gcp ppt cr by ann 1. Why separate GCP for India? Contents 1. Definitions 2. Pre-requisites for the study 2. Responsibilities 3. Quality Assurance 6. Statistics 7. Special Concerns 7. Prerequisites for the study 2.

Any structural similarity ies to the other known compounds should be mentioned. Relevant components of Protocol 1. General Information a Protocol title, protocol identifying number and date. Objectives and Justification a Aims and objectives of the study, b Name and description of the investigational product c A summary of findings from non-clinical studies d Description of the IE criteria of the study population e Summary of the known and potential risks and benefits, if any, to human subjects Inclusion, Exclusion and Withdrawal of Subjects a Includes subject inclusion criteria, Exclusion criteria, withdrawal criteria 6.

Handling of the Product s 7. Assessment of Efficacy a Description of how effects are measured and recorded and Time and periodicity of effect recording 8. Assessment of Safety 9. Statistics Quality control and quality assurance Finance and insurance a Mention all financial aspects of conducting and reporting a study Publication policy Evaluation a specified account for how the response is to be evaluated including methods of computation and calculation of effects.

Expected duration 3. Reasonably expected benefits 4. Alternative procedures if any 5. Foreseeable risks 6. Extend of confidentiality of the subjects 8. Free treatment to research related injury 9. Compensation Voluntary participation Study management, data handling and record keeping 4. Compensation for participation 5. Confirmation of review by the ethics committee 6. Information on Investigational products 7. Supply, storage and handling of Pharmaceutical products 8.

ADR reporting 9. Study Reports IP is available and stored properly 2. IP is supplied to only persons eligible to receive it 3. Subjects are provided necessary information 4. Investigator receives current IB Investigator follows protocol 7. Investigator maintains ED 8.

The number of Subjects to be included in the study is determined in relation to the statistical model on which the Protocol is based. The phase of these trials differ from drug trials as given below: 1.

Subjects should be clearly informed about the alternative available. The relative risks and benefits of research proposal utilizing radioactive materials or X-rays should be evaluated. Radiation limits for the use of such materials and X-Rays should be in accordance with the limits set forth by the regulatory authority BARC for such materials.

Chemical and Pharmaceutical Information Regulatory status in other counties Marketing information Safety Pharmacology Functional indices of toxicity. Reproductive and developmental toxicity 6. Genotoxicity studies 7.

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Clinical Trials: Changing Regulations in India

The academician forms the backbone of any medical college, hospital or university and shoulders the quadruple responsibilities of patient care, teaching, administration and research. Of these, research, though long and difficult, is extremely fulfilling. Academicians often carry out research that is based on observations in practice or in response to their patient's needs. In the past decade, several changes have dotted the regulatory landscape in the country and have changed the way in which academic research is carried out. How to improve R and D productivity: The pharmaceutical industry's grand challenge. Nat Rev Drug Discov ; Sanders RD, Maze M.


Indian GCP: Do we really need it?

The importance of drug trials in promoting health services cannot be overemphasized. New drugs and therapies can improve the quality and lifespan of patients. While it is imperative that the number of clinical trials increase, the Government is also trying to ensure that the rights and safety of the subjects are protected and the quality of the trials performed in India improve to international standards. The regulatory guidelines in terms of serious adverse events SAEs reporting, informed consent, compensation in case of injury or death in clinical trials have been recently modified. This article summarizes the essential information all researchers planning to conduct a clinical trial in India should know and follow. A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile including pharmacodynamic and pharmacokinetic or adverse effects of a new drug on humans. It is important for anyone preparing a trial of a new therapy in humans that the specific aims, problems and risks or benefits of a particular therapy be thoroughly considered and that the chosen options be scientifically sound and ethically justified.



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