ASSOCIATION OF THE SHANK3 GENE COUPLED WITH 22Q13.3 DELETION SYNDROME Journal title: International Journal of Research and Development in Pharmacy & Life Sciences (IJRDPL) Authors: Vellingiri Balachandar| Department of Human Genetics and Molecular Biology, Bharathiar University, C... Subject(s): Biochemistry, Genetics, Microbiology, Zoology and Animal Science, Pharmacology, Toxicology
Phelan-McDermid Syndrome Presenting as a Puzzling Case of Regressive Autism Journal title: Journal of Pediatrics & Child Care Authors: Jennifer Cross Subject(s):
OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION Journal title: International Journal of Drug Regulatory Affairs Authors: Jitendra Kumar Badjatya Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING Journal title: International Journal of Drug Regulatory Affairs Authors: Kothari Charmy, Shah Kavina Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
EXCLUSIVITY STRATEGIES OF INNOVATOR DRUG DEVELOPERS Journal title: International Journal of Drug Regulatory Affairs Authors: Chaitanya Prasad K, Prabodh M, Ashish S, Suthakaran R., Naveen Reddy M,, Ravindra Reddy M Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
REGULATORY STRATEGY FOR REGISTRATION OF COMBINATION PRODUCTS TO US-FDA Journal title: International Journal of Drug Regulatory Affairs Authors: Kotha Vihar, Elphine Prabahar, Rama Rao Nadendla, Desu Bhrama Srinivasarao Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines Journal title: International Journal of Drug Regulatory Affairs Authors: Saffiya khatun M, Jyothshna Devi Katamreddy, Jayachandra Reddy. P Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
Preliminary requirement for ANDA Filing Journal title: International Journal of Drug Regulatory Affairs Authors: Snehal Shah, Jitendra Kumar Badjatya Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
Integrating PLCM strategy in Pharmaceutical Emerging Market Journal title: International Journal of Drug Regulatory Affairs Authors: Swagat Tripathy, Padala Narasimha Murthy, Bibhu Prasad Patra Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products Journal title: The AAPS Journal Authors: Celia N. Cruz, Katherine M. Tyner, Lydia Velazquez, Kenneth C. Hyams, Abigail Jacobs, Arthur B. Shaw... Subject(s): Medicine
