1. NATURAL PRODUCT DERIVED COMBINATORIAL LIBRARY AND IT’S SIGNIFICANCE IN DRUG DISCOVERY PROGRAMMES Presented by: ANZAR ALAM M.Pharm 2 nd Sem Pharmacognosy & Phytochemistry FACULTY OF PHARMACY JAMIA HAMDARD Presented to: Dr. (Prof.) S.H.Ansari Dean Student Welfare (DSW) JAMIA HAMDARD
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4. The Long Road to a New Medicine Discovery Exploratory Development Full Development Registration Large Amounts of Candidate Medicine Synthesized Project Team and Plans Synthesis of Compounds Early Safety Studies Candidate Formulations Developed Extensive Safety Studies Screening Studies in Healthy Volunteers Phase I Candidate Medicine Tested in 3-10,000 Patients (Phase III) Studies in 100-300 Patients (Phase II) Clinical Data Analysis
25) Idea-to-new medicine road - Full Development phase In this Full Development stage, known as Phase lll, several thousand patients with the particular disease receive the drug in carefully controlled studies to test its safety, tolerability, and efficacy. Finally, if the compound has proved its worth in all these tests, it enters the Registration phase in which the data of its entire history are compiled and analyzed in a regulatory submission. This New Drug Application, or NDA, is submitted to the FDA for review. In parallel, a Marketing Authorization Application (MAA) is filed in Europe, followed by a Japanese NDA. Only after a successful regulatory review does the candidate become a new medicine.