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Drug Discovery Process.
- 2. 10,000 compounds 5 compounds 250 compounds 1 compound Stage 1 : Early drug discovery Stage 2 : Pre clinical phase Stage 3 : Clinical phase Regulatory Approval Drug Discovery Process
- 3. • Pre-clinical trials • IND • NDA • ANDA • Phase 0 • Phase 1 • Phase 2 • Phase 3 • Phase 4
- 4. Pre-clinical trials Steps 1. Identify drug target 2. Develop a bioassay 3. Screen the drug in the assay 4. Establish effective and toxic doses 5. File for approval as an IND
- 5. To identify initial safe dose in humans Identify target organs for toxicity The study of whether toxicity is reversible or not Identify safety parameters for clinical monitoring
- 6. Investigator IND Emergency IND Treatment IND Submitted by a physician who both initiates and conducts an investigation and under whose immediate direction the investigation drug Types : The FDA authorizes the use of an experimental drug in an emergency situations It is submitted for experimental drugs in clinical testing of serious or life-threatening conditions Commercial IND These are submitted by companies to obtain marketing approval for a new product
- 7. Applicant Drug sponsor IND Review by CDER Sponsor submits new data Chemical hold decision Notify sponsor Safety review Safety acceptable for study to proceed Complete review Sponsor notified of deficiencies Review complete and acceptable Study ongoing No deficiencies Statistical Pharmacology /toxicology Chemistry Medical Yes Yes Yes No No No Investigational New Drug Application
- 8. New Drug Approval The vehicle through which drug sponsors formally propose that the FDA approved a new pharmaceutical for sale and marketing Applicant / Drug sponsor NDA Application fileable Refuse to file letter issued Medical Review by CDER Pharmacology Chemistry Advisory committee meeting Biopharmaceutical Meeting with sponsor Microbiology Statistical Review complete and acceptable Inspection of the site available NDA action Sponsor Labeling review acceptable Pending satisfactory results Additional information / revision requested Yes Yes Yes Yes No No No No
- 9. Abbreviated New Drug Approval Applicant Chemistry / micro labeling review acceptable Refuse to file letter issued Acceptable and complete ANDA Bioequivalence review Request for plan inspection Bioequivalence review acceptable Labeling review Chemistry /micro review Not applicable letter Bioequivalence deficiency letter Pre-approval inspection acceptable Approval deferred pending satisfactory results ANDA approval No No No No Yes Yes Yes
- 11. OBJECTIVE : Human pharmacology studies To identify the safety, tolerability and pharmacokinetic studies. Food studies are done to understand absorption and adverse drug reaction with respect to the impact of food on drugs
- 12. Therapeutic Exploratory Trials The safety and efficacy of the new investigational drug product Phase 2 A- Pilot studies designed to demonstrate the clinical efficacy Phase 2B- To determine the optimal dose OBJECTIVE :
- 13. A definitive assessment of the safety and efficacy of these trials will be designed as multi- center, randomized trials
- 15. Over view Pre-clinical Clinical Initial synthesis Animal testing Range 1-3 years FDA time 30 days Safety review 2-10 years I N D A P P L I C A T I O n Phase 1 Phase 2 Phase 3 N D A NDA submitted Post marketening Adverse reaction reporting Phase 4 N D A A P P R O V E D Review 1 year
- 16. References : 1. Preclinical Animal Studies - Bing images 2. Investigational New Drug (IND) Application | FDA 3. Abbreviated New Drug Application (ANDA) (investopedia.com) 4. Phases of Clinical Trials | Cancer.Net 5.New Drug Application (NDA) | FDA