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Chapter-29 New Drug Development

BOOK TITLE: Practical Manual of Pharmacology for Medical Students

Author
1. Badyal Dinesh
ISBN
9789352702411
DOI
10.5005/jp/books/18065_30
Edition
2/e
Publishing Year
2018
Pages
4
Author Affiliations
1. Christian Medical College, Ludhiana, Punjab, India
Chapter keywords
New drug development, animal toxicity, clinical trial, good clinical practice, GCP, investigational new drug, exploratory trial, confirmatory trial

Abstract

New drug development involves animal toxicity studies followed by clinical trial in humans. Potentially useful compounds are studied in animals to evaluate desired effects and toxicity. Animal toxicity studies are done to see whether the chemical is safe or not. For all new drugs, it is mandatory to do toxicity studies in animals. After that the drug enters various phases of clinical trials. Drug development is an extremely arduous, highly technical, time-consuming and very expensive process. Clinical trial is defined as “a carefully and ethically designed experiment with the aim of answering some precisely framed questions”. Clinical trial is systematic study of pharmaceutical products on human subjects—(whether patients or non-patient volunteers)—in order to discover or verify the clinical, pharmacological (including pharmacodynamics/pharmacokinetics) and/or adverse effects, with the object of determining their safety and/or efficacy. There can be 4–5 phases of clinical trials, i.e. phase 0, phase I, phase II—exploratory trials, phase III—confirmatory trials and phase IV.

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