Tuesday , 22 September 2020

Tag Archives: FDA

An Evaluation and Comparative study of Regulatory Requirements for Registration of Generic Injectables in USA, European Union and Canada

Jaldu Praveen*, K Sreejan1, 2P. Jaya Chandra Reddy *1Krishna Teja Pharmacy College, Renigunta Road, Tirupathi. *2Principal Krishna Teja Pharmacy College, Renigunta Road, Tirupathi. A B S T R A C T Regulatory affairs professionals are key players in drug development to approve and through life cycle management of a drug. They are the primary communications link between the company and ... Read More »

Prospective Study of Good Practice for Management of Comments / Deficiencies in CTD/eCTD

B. Ranganayakulu*, B.Nagalakshmi1, Dr. S. Mohammed Yusuf2, Dr.A.Srikanth3, N. Ravi Kumar4 *,2Associate Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India 1,4Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India 3Assistant Professor, Vasavi Institute of Pharmaceutical Sciences, Kadapa, A.P., India Int. J. Med. Pharm. Res.,  2020, 8(1): 5-8 A B S T R A C T eCTD or electronic common technical document ... Read More »

Risks and Opportunities in Development of New Drug

Talagana Praveena1*, Dr. K. Harinadha Baba2, S Sivaprasadh3 1,3Sri sivani College of Pharmacy, JNTUK, Kakinada 2Principal Sri sivani College of Pharmacy, JNTUK, Kakinada A B S T R A C T Pharmaceutical development is a costly, time exhausting and uncertain process that takes years to accomplish. In many instances, patent protection expires before a new drug is approved for marketing. ... Read More »

A COMPARISION OF ANALYTICAL METHOD VALIDATION PROCEDURES

About author: Chinmaya Keshari Sahoo* Research Scholar,Dept. of Pharmaceutics, OUCT, Osmania University,A.P, India *e-mail: sahoo.chinmaya83@gmail.com INTRODUCTION : Analytical method validation is a regulatory requirement that refers to the evaluation and proving that the selected analytical method shall ensure reproducible and reliable results adequate for the intended purpose.The process of analytical method validation should demonstrate that the method is fit for ... Read More »

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