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This presentation is a summary of the BABE Concept and Biowaiver which was prepared after the Semina...
CRO
Regulatory Requirements For New Drug Approval. This topic is from Industrial Pharmacy-II, B.Pharm Fi...
Product Development & Technology Transfer
Schedule y
In Japan, the pharmaceutical industry operates under strict regulatory oversight by the Pharmaceutic...
BA and BE studies. Seminar presented in All India Institute of Medical Sciences (AIIMS - New Delhi)...
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug wh...
pharmaceutical development report PDR is the one of the significant document of CTD (common technica...
Biopharmaceutical Classification System
BCS classification
Lecture Objectives After completion of lecture, students will be able to: • Describe bioavailab...
Biosimilars, its development and it's regulatory guidelines.
Hatch waxman act Regulatory affairs (ceutics)
This slide describes about the ICH GUIDELINES ON MULTIDISCIPLINARY
introduction in biowaiver
NDCT STANDS FOR NEW DRUG CLINICAL TRIAL RULE. HERE YOU WILL GET TO KNOW ABOUT THE NDCT RULE HISTORY,...
SCHEDULE Y, OECD PRINCIPLE OF GLP & IMPORTANCE DRUG DEVELOPMENT
Elimination Bioavailability and �Bioequivalence Factors Affecting Renal Excretion or Renal Clearan...
central drug standard control organisation
This presentation explains the basic concepts of bioavailability which is an important part of pharm...
#ppt
SUBJECT - DRUG REGULATIONS TOPIC-CENTRAL TESTING LABORATORIES IN INDIA
