Check COD Availability

Approaching China's Pharmaceutical Market: A Fundamental Guide to Clinical Drug Development Paperback – Import 28 Oct 2016

by Sanapalas
16,449.00 INR

Product Description From the Back Cover This authoritative volume examines the major laws regulations and guidelines related to pharmaceutical product development in China. With a focus on patent clinical and registration strategies the book helps Western companies introduce their clinical drugs to the Chinese market determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process it explores the differences between the China Food and Drug Administration (CFDA) including its regulations and registration procedures and those of the Western world. The volume discusses disparities between China's application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. Overall this book offers guidance for Western companies aspiring to expand into China s pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future issues." About the Author 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.

The book summary and image may be of a different edition or binding of the same title.; Book reviews are added by registered customers. They need not necessarily buy book.; These books are NOT available for reading online or for free download in PDF or ebook format unless specially specified.; Price can change due to reprinting price change by publisher or sourcing cost change for imported books.;Price can change even after customer buys the book due to inability to monitor pricing of vast number of books.In such cases,customer is intimated to pay additional price or refund will be done immediately after order cancellation is confirmed by the customer. is the biggest online bookstore in India for sale of books at best price - fiction literature audiobooks study guides novels story books rare books textbooks and books by popular authors. These are available in various editions and bindings e.g. paperback and at best discount.;

Back to the top