S. Sandhya*1, K. Sunil Kumar2 1Department of Pharmaceutics – Drug regulatory affairs, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India. 2Associate Professor, Department of Pharmaceutics – Drug regulatory affairs, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India. A b s t r a c t Development of new drug is a complex, ... Read More »
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Tag Archives: FDA
A Comaprative Analysis of New Drugs and Clinical Trials Rules and Its Impact on Approval Process of Oncology Drugs in USA, CANADA, AUSTRALIA, EUROPE and INDIA
K. Sunil Kumar*1, Panthagiri Thulasi2 1Associate Professor, Department of Pharmaceutics and DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India 2Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India A b s t r a c t The FDA approves drugs through the clinical trials process. Every clinical trial has a sponsor to ... Read More »
Regulations on Pharmaceutical Products and Medical Devices in USA
B. Ranganayakulu*, P. Lakshmi Gurunath Kumar1, Dr. S Mohammed Yusuf2, Dr. A. Srikanth3, C. Venugopal Rao4 *, 2, 4 Associate Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India 1Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India 3Assistant Professor, Vasavi Institute of Pharmaceutical Sciences, Kadapa, A.P., India A B S T R A C T The United States (U.S.) regulates ... Read More »
Common Deficiencies in Regulatory Submissions
CH. Vasavi1*, D. Priyadharsini2, Dr. K. Harinadha Baba3, N. Uma4 1,4Sri Sivani College of pharmacy, JNTUK, Kakinada 2Asst. Professor, Sri sivani College of Pharmacy, JNTUK, Kakinada 3Principal Sri sivani College of pharmacy, JNTUK, Kakinada A B S T R A C T This concludes our discussion on the commonly cited deficiencies for control of the drug product and stability. This ... Read More »
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 »