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New Drug Approval Process
Accelerating Global Registrations
Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.
Textbook of Neonatal Resuscitation 2011 US$ 55.95 347 pages
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Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide) 2014 US$ 126.56 641 pages
The Human Brain Book 2014 US$ 40.00 266 pages