Journal article Open Access

MANAGEMENT PROCESSES DURING DRUG DEVELOPMENT: A SPECIAL REPORT ON RESEARCH & DEVELOPMENT IN CRO'S AND PHARMACEUTICAL COMPANIES

Amol B. Garde*, Dipali Jagtap, Ashish S. Pagariya

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.

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