COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL Journal title: International Journal of Drug Regulatory Affairs Authors: Joseph Lincy, George Mathew, Malaviya Kalpesh K, Chacko Bincy K, Badjatya Jitendra Kumar Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness
A critical view of harmonization of regulatory requirements for Generic Drug approval submissions in ASEAN countries Journal title: International Journal of Drug Regulatory Affairs Authors: Jyoti Ghangas, Neha Jain, Anshuman Sinha Subject(s): Medicine, Internal Medicine, Pharmacology, Pharmacy, Toxicology, Health and Wellness