Drug Development and approval process

Drug Development and Approval Process Steps MOHAMMAD YUNOOS, M.Pharm., (Ph D) ASSISTANT PROFESSOR NIMRA COLLEGE OF PHARMACY VIJAYAWADA : 

Drug Development and Approval Process Steps MOHAMMAD YUNOOS, M.Pharm., (Ph D) ASSISTANT PROFESSOR NIMRA COLLEGE OF PHARMACY VIJAYAWADA 1 MOHAMMAD YUNOOS

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Drug Development and Approval Process Steps 1. Discovery 2. Non-clinical Animal Testing 3. Product & Process Development - Chemistry, manufacturing and Control 4. Investigational New Drug Application (IND) 5. Clinical Trials (Phase 1, 2, 3) 6. New Drug or Biologics License Application (NDA or BLA) 7. Market Approval 8.Phase 4 9.Abbreviated New Drug Applications(ANDAs) 10.NDA and ANDA Supplements 11.Annual Reports 12. Drug Master Files (DMFs) 2 MOHAMMAD YUNOOS

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FDA Regulations – 21 CFR … Part 11 – Electronic records and Signatures Part 58 – Good Laboratory Practices - nonclinical Part 50 – Protection of Human Subjects – clinical trials Part 54 – Financial Disclosure Part 56 – Institutional Review Boards – clinical trials Part 312 – Investigational New Drug Application Part 314 – New Drug Application Part 601 – Biologics License Application Part 812 – Investigational Device Exemption Part 807, Subpart E – Premarket Notification 510 Part 814 – Premarket Approval Application – Devices 4 MOHAMMAD YUNOOS

NonClinical Research (in vitro or in vivo studies in animals) : 

NonClinical Research (in vitro or in vivo studies in animals) Early Feasibility Studies - what works. Pharmacology Studies– where does it go Efficacy Studies – how well does it work and what does it do in the body. Dose Ranging Studies – how much does it take to work. Safety Studies – what adverse effects does it produce ( 21 CFR 58) Biocompatibility Studies - for devices 5 MOHAMMAD YUNOOS

Clinical Development for Drugs : 

Clinical Development for Drugs Phase 1 – safety studies in ~20 to 80 normal subjects, pharmacokinetics and pharmacology data help design Phase 2. Phase 2 – efficacy and safety in ~few hundred subjects who have the indicated disease. Phase 3 – expanded to determine benefits and risks in a particular disease population in several hundred to thousands of patients. Additional Animal Studies : Long Term – chronic studies Carcinogenicity Mutagenicity Teratogenicity 6 MOHAMMAD YUNOOS

Drug Approval Process: Beginning to End: 

Drug Approval Process: Beginning to End 7 MOHAMMAD YUNOOS

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Filing the Investigational New Drug Application (IND): 

Filing the Investigational New Drug Application (IND) Introductory Statement and General Investigational Plan. Investigators Brochure Clinical Protocol. Chemistry, Manufacturing and Control Information Pharmacology & Toxicology -Information in Animals Previous Human Experience Requires a 30 day wait period prior to start 9 MOHAMMAD YUNOOS

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Drug Market Application: NDA, BLA or Common Technical Document: 

Drug Market Application: NDA, BLA or Common Technical Document Summary of the data Nonclinical Pharmacology and Toxicology studies Chemistry, Manufacturing and Control Human Pharmacokinetics and Bioavailability / Bioequivalence Clinical Data Statistics Samples and Labeling Case Report Forms and Tabulations Patents Establishment Description 11 MOHAMMAD YUNOOS

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Supplements to nda & anda: 

Supplements to nda & anda It is required if there is a proposed change in the drug or labelling and changes can not put into place until FDA approves them. Or Significant change in the manufacture, control, packaging or physical properties of drug which may effect on safety and effectiveness. Changes to be report in next periodic: 1. Different container size / closure system. 2. Change in the description of drug product. 3. Minor change in the labelling. 4. Deletion of color ingredient. 5. Inclusion of additional specifications. 13 MOHAMMAD YUNOOS

Drug Master Files (DMFs) : 

Drug Master Files (DMFs) Type 1: Facilities Type 2: Drug Substance Type 3: Containers & Closures (screw caps, glass, bottles, syringes, rubber stoppers, etc.) Type 4: Colors, Flavors, Excipients Type 5: Microbiology 14 MOHAMMAD YUNOOS

GENERIC DRUG : 

GENERIC DRUG Requirements for a generic drug product: Same active ingredient(s) Same route of administration Same dosage form Same strength Same conditions of use Compared to reference listed drug (RLD) -(brand name product) found in the ‘Orange Book’ NDA vs. ANDA Review Process Brand Name Drug Generic Drug NDA Requirements ANDA Requirements 1. Chemistry 1. Chemistry 2. Manufacturing 2. Manufacturing 3. Controls 3. Controls 4. Labeling 4. Labeling 5. Testing 5. Testing 6. Animal Studies 7. Clinical Studies 6. Bioequivalence 8. Bioavailability 15 MOHAMMAD YUNOOS

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GENERIC DRUG APPROVAL PROCESS : 

GENERIC DRUG APPROVAL PROCESS 17 MOHAMMAD YUNOOS

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