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[Cites 0, Cited by 0] [Section 122DA(3)] [Section 122DA] [Entire Act]

Union of India - Subsection

Section 122DA(3)(a) in The Drugs and Cosmetics Rules, 1945

(a)"Clinical Trial" means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug;