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Tag Archives: USFDA

Regulatory Requirement for the Quality Improvement Plan for a Stabilized Product Development

Nandini Ramani*, Y. Sai Phanendra, G. Sirisha, Doonaboyina Ragava, Kavala Nageswara Rao Department of Pharmaceutical Drug Regulatory Affairs, K. G. R. L College of Pharmacy, Bhimavaram-534201, A.P, India A B S T R A C T The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. ... Read More »

Current Research and Regulatory Steps for Further Development of Clinical Trials in India

Kotipalli Jyothirmaye*, Yarra Sai Phanindra, Beram Saranya, Doonaboyina Raghava, Kavala Nageswara Rao Department of Pharmaceutical Drug Regulatory Affairs, K.G.R.L College of Pharmacy, Bhimavaram-534201, Andhra Pradesh, India A B S T R A C T In drug development, two partly overlapping phases can be differentiated, namely the preclinical and clinical phase. During the first part of drug development necessary requirements for ... Read More »

Observations on Guidelines for Post Marketing Surveillance for Pharmaceuticals

A. Kusumanjali*, J. Praveen Kumar1, E. Vijay Kumar2, Dr. P. Jaya Chandra Reddy3, Dr. S. Mohammed Yusuf4 *Krishna Teja Pharmacy College, Tirupati, A.P., India. 1Associate Professor, Krishna Teja Pharmacy College, Tirupati, A.P., India. 2Assistant Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India. 3Principal, Krishna Teja Pharmacy College, Tirupati, A.P., India. 4Associate Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India. ... Read More »

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