Brief description of the documents required for ANDA submission

What is drug design ? How drug can be designed ? rational drug design structure based drug design computer assisted drug design 3D- QSAR Examples of drug design Zanamivir…

ANDA Abbreviated New Drug Application BY N.NARESH KUMAR m.pharm(cology) Definition of ANDA:  AN “abbreviated new drug application” (ANDA) is an application for a US…

1. Translational Drug Discovery Transforming Science into Medicine Andy Plump, MD, PhD Deputy to the President R&D, Research & Translational Medicine tranSMART Chilly-Mazarin/Longjumeau…

Slide 1Stroke Management in Developing Countries Junaid A. Razzak MD PhD FACEP Chief, Section of Emergency Medicine Aga Khan University Karachi, Pakistan Slide 2 4 out of…

1.Regulatory IND Process James Ault,RAC, RQAP-GLP VP Quality and Regulatory Affairs Ricerca Biosciences, LLC May 23, 2007 Quality and Regulatory Affairs2. Regulatory IND…

1. By Suyog Pratap Sulake M.Pharm (Sem-I) Under the Guidance of Dr. N.H. Aloorkar (M.Pharm Ph.D) (Head of Department of Pharmaceutics) Satara College of Pharmacy,Satara.…

1. New Drug Application(NDA)Vs Abbreviated new drug application(ANDA) Name:B.Vamsikrishna Reddy Year :M.Pharm (Pharmaceutics) College : Manipal College of PharmaceuticalScieces(MCOPS),…

Ethical concerns in clinical trials in India: an investigation Sandhya Srinivasan Research team Sandhya Srinivasan Sachin Nikarge Centre for Studies in Ethics and Rights,…

1. AGENDA  Paramedical Landscape - Fraud/abuse  Drugs, “The Changing Landscape”  Past/Future trends  Industry – EP3  Plan Design, Action or Apathy? 2.…