PTSM 2 unit 1 SCHEDULE Y, OECD PRINCIPLE OF GLP & IMPORTANCE DRUG DEVELOPMENT.pptx

SCHEDULE Y, OECD PRINCIPLE OF GLP & IMPORTANCE DRUG DEVELOPMENT

1. SUBJECT : TOXICOLOGY SCREENING METHOD II TOPIC : SCHEDULE Y, OECD PRINCIPLE OF GLP & IMPORTANCE DRUG DEVELOPMENT PRESENTED BY ANSARI AASHIF RAZA ( IInd semester , M.PHARM) DEPARTMENT OF PHARMACOLOGY Department of Pharmacology

2. SCHEDULE -Y Requirement and guidelines for permission to import and /or manufacture of new drugs for sale or to undertake clinical trials. PURPOSE OF SCHEDULE-Y To frame guideline for conduct of clinical research control and regulation for new drugs CDSCO and DTAB formulated GCP under schedule Y in 2005

3. DRUGS AND COSMETIC ACT 1945 RULE PERMISSION FOR 122A To import new drugs 122B To manufacture new drugs 122D To import or manufacture fixed dose combinations 122DA To conduct clinical trials for new drug/investigations new drug 122DAA Definition of clinical trials

4. Requirement And Guideline On Clinical Trials For Importing And Manufacturing Of New Drugs. Application for permission Clinical trial Studies in specific population Post marketing surveillance Special studies : bioavailability/ bioequivalence.

5. APPENDICES OF SHEDULE Y Appendix 1: Data to be submitted along with the application to conduct clinical trials/import/manufacture of new drugs for marketing in the country Appendix 1A: Data required to be submitted by an applicant for grant of permission to import and /or manufacture a new drug already approved in the country Appendix 2 : Structure, contents and format for clinical study reports Appendix 3 : Animal toxicology (non-clinical toxicity studies) Appendix 4: Animal pharmacology Appendix 5 : Informed consent Appendix 6 : Fixed dose combinations ( FDC’s ) Appendix 7 : Undertaking by investigator Appendix 8 : Ethics committee Appendix 9 : Stability testing of new drugs Appendix 10 : Contents of the proposed protocol for conducting clinical trial Appendix 11 : Data elements for reporting serious adverse events occurring in a clinical trial.

6. OECD The Organisation for Economic Co-operation and Development, abbreviated as OECD and based in Paris (FR), is an international organisation of 38 countries committed to democracy and the market economy.

7. OECD PRINCIPLE OF [GLP] GOOD LABORATORY PRACTICE . The  Principles of Good Laboratory Practice (GLP)  are a managerial quality control system covering the organisational process and the conditions under which non-clinical health and environmental studies are planned, performed, monitored, recorded, reported and retained (or archived).  The OECD Principles of GLP are followed by test facilities carrying out studies to be submitted to receiving authorities for the purposes of assessing the health and environmental safety of chemicals and chemical products which may also be of natural or biological origin and, in some circumstances, may be living organisms. The Principles of GLP define the responsibilities of test facility management, study director, study personnel and quality assurance personnel that are operating within a GLP system, and minimum standards concerning the suitability of facilities and equipment to perform studies, the need for standard operating procedures, documentation of raw data, study reports, the archiving of records, etc.

8. REFERENCE Pharmacology and toxicology screening method by pubmed press https://www.slideshare.net/aiswarya95thomas/drug-discovery-history-evolution-and-stages https://www.oecd.org/chemicalsafety/testing/good-laboratory-practiceglp.htm