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The top documents tagged [new drug applications]
White Paper | Adaptive Design
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Oral solid dosage manufacturing guidance
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TU06 Paper
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J.P. Morgan Healthcare Conference January 7, 2013
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ECTD – A TOOL to QUICK /RELIABLE REGULATORY SUBMISSION Abhay Muthal M.Pharm, Ph.D Sun Pharm Inds Ltd. Vadodara, India
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Action Research Gabriela Bacal May 28 th, 2004. Exploring Additional Classes Nanotechnology
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Design and Statistical Analysis of Thorough QT (TQT) Studies Yi Tsong, Ph.D., CDER/FDA Co-author – Joanne Zhang, Ph.D., CDER/FDA The opinions presented
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Tools to Reduce Phase III Trial Failures Lawrence J. Lesko, Ph.D., FCP Director of the Office of Clinical Pharmacology and Biopharmaceutics Center for
219 views
© Paradigm Publishing, Inc. 1 Chapter 2 Pharmacy Law, Regulations, and Standards
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WTO: TRIPS agreement Minimum universal standards for copyrights, patents and trade marks 20 year patent protection for medicines Criteria: Novelty, Inventiveness
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AJPSR41
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Paying for Pharmaceutical Regulation Warren Kaplan Richard Laing Boston University School of Public Health
220 views
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