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![]() ![]() Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India. Guidelines from official website of CDSCO h ttp:// ![]() Guidelines for Import and Manufacture of Medical Devices by CDSCO Guidance for Industry on Requirement of Chemical & Pharmaceutical Information including Stability Study Data before approval of clinical trials, BE studies by CDSCO Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy by CDSCO (Central Drug Standard Control Organisation) ICH E6 Guideline ― Good Clinical Practice‖ by ICH Harmonised Tripartite ICMR Ethical Guidelines for Biomedical Research: Įthical Guidelines for Biomedical Research on Human Participants by Indian Council of Medical Research, New DelhiĬPCSEA Guidelines for Laboratory Animal Facility by Committee for the purpose of control and supervision on experiments on animals (CPCSEA) ![]() Medicines and Healthcare products Regulatory Agency: Ĭentral Drugs Standard Control Organization Guidance for Industry: Guidelines of International Conference on Harmonization: Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143
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