Abstract
DRUG DEVELOPMENT MANAGEMENT: AN APPROACH TO R&D MANAGEMENT IN PHARMACEUTICAL COMPANIES AND CRO’S

*Ankit Paliwal, Saurabh Sharmam and 3Nikhil Shrivastava

ABSTRACT

The most successful new drug-development programs require competent, caring, people-oriented leaders at all levels. Overwhelming social science data show that this approach will optimize productivity, efficiency, and creativity, while fostering employee growth, enthusiasm, cooperation, and loyalty. Companies are organized differently; for example, the various engineering responsibilities may be in one or more departments. A brief description of typical functions follows: _ Synthetic chemistry synthesizes NCE candidates for pharmacological testing. Pharmacology examines the in vivo activity of the NCE in animals. Other involved departments/disciplines that are equally important as the above groups include Analytical Chemistry, Biochemistry, Biopharmaceutics/ Pharmacokinetics/Drug Metabolism, Chemical Pilot Plant, Experimental Engineering, Packaging Development, and Statistics. Additional significant contributors include Purchasing and Quality Assurance/ Documentation.

Keywords: Drug-development programs, Investigative New Drug (IND) application, Product R&D, Quality Assurance/ Documentation.


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