NEW DRUG APPLICATION!!!

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Hello my dear student friends, I hope everyone is busy and doing well in the exams!! With the new igniting minds i hope every one of you want to do something new. Coming to our profession, Novelty, Utility and Non Obviousness-(the major essentials of a patent) are necessary whenever you discover a new product. Before you begin the clinical trials first thing you need to do is, apply for Investigational New Drug Application or IND. A brief discussion of IND will be given by Gangadhar Hari!! Coming to my topic - New Drug Application. After filing IND if FDA were satisfied with all the contents the next step is to head towards NDA. An NDA can be applied during ongoing Phase III trials or after the due process. The important contents in NDA include: 1. Name, Proprietary code name or number of the product. 2. Whether our new product is to be sold under prescription drugs or as OTC form. 3. General investigative plan giving brief description of all the processes that were carried out - Physical properties of the drug, Pharmacological class to which it belongs, Pharmacological and Toxicological effects, Pharmacokinetic profile of the drug, Chemistry , Manufacturing and other In Process Controls etc. 4. The next step is to give detailed explanation for the technical section that deals with the Chemistry, Manufacturing and Controls. This include Structure activity Relationship, Manufacturing process employed and various in process controls that need to be predetermined and adjudged. 5. Technical sections related to Pharmacokinetic profile including Bioavailability tests giving a detailed note on Absorption, Distribution, Metabolism, Excretion, pKa, Volume distribution etc. 6. Pharmacological and Toxicological effects need to be clearly and completely specified. Major side effects like Carcinogenicity, Reprotoxicity, Genotoxicity, Acute or Chronic toxic reactions should be reported. 7. An approval letter from International Review Board (IRB) should be submitted. 8. Information Brochure with lucid explanations should be submitted. 9. Stability and Shelf life studies should be mentioned. 10. A clear invoice bills of IND, signature and date of IND approval must be submitted to avoid disarray. THIS BLOG IS FREE OF PLAGIARISM. Ref: http://fdadrugcompliance.com/resources/nda/ accessed as on October 16th 2011.
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Sandhya Sravya malla's picture

very informative sir!!! m.sandhyasravya
Dr Girija Sankar's picture

Thank you!

Dr.G.Girija Sankar, Associate Professor Department of Pharmaceutical Biotechnology, College of Pharmaceutical Science, Andhra University.

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