Approaching China's Pharmaceutical Market

11.08.2015

Englisch

9783319155753

Springer International Publishing

Nein

648

Gebundene Ausgabe

A Fundamental Guide to Clinical Drug Development

Ming Q. Lu, M.D., Ph.D, is a senior medical director at Helsinn Therapeutics, Inc. He received his M.D in P.R. China and his Ph. D from the University of Connecticut, and completed a fellowship at Johns Hopkins Medical Schools under academician Peter Agre, M.D, who in 2003 received the Nobel Prize. Dr. Lu has expansive experience in both academia and pharmaceutical industry, particularly in research and development (R&D) of new medications. Since 1998, he has been heavily involved in the conduct and management of various aspects of clinical drug research and development, running the gamut from project initiation, to drug candidate discovery, and from pre-clinical pharmacology to all the clinical phases in both the US and overseas, especially in mainland China. He has also chaired the regulatory filing and defense processes with China Food and Drug Administration (CFDA), leading to the success of marketing approval in both China and Hong Kong.

CFDA, FDA, drug management law, investigational drug, regulatory guidance

PNB - Medizinische Chemie, Pharmazeutische Chemie

235 mm

15.5 cm