Tuesday , 7 July 2020

Life Cycle of Drug Regulations on Pharmaceutical Product and Observations on Drug Master Files

D. Kishor Kumar*, J. Praveen Kumar1, C.P. Sreekanth Reddy2, P. Jayachandra reddy3, G.Maheswari4
*Krishna Teja Pharmacy College, Tirupati, A.P., India

1Associate Professor, Krishna Teja Pharmacy College, Tirupati, A.P., India
2Assistant Professor, Krishna Teja Pharmacy College, Tirupati, A.P., India
3Principal, Krishna Teja Pharmacy College, Tirupati, A.P., India
4Assistant Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India

A B S T R A C T
The pharmaceutical industry has faced declining R&D productivity, a rapidly changing healthcare landscape and fierce competition from generics resulting in lower growth and profit margins. Historically, drug development focused on clinical trials management and outcomes. Now however, the industry is looking at more holistic approaches to improve processes of bring new products to market that can accelerate product development while lowering operational costs.

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