Title	Published	Price
Good Clinical Practice: A Question & Answer Reference Guide 2011 By: Barnett Educational Services ... for patient recruitment. A new chapter featuring exclusive interviews with Leslie Ball, M.D., director of CDER's Division of Scientific Investigations (DSI), and Joanne Less, M.D., director of FDA's Good Clinical Practice Program on the priorities ... \| more...	8/1/2011	$45.95
PAREXEL Biopharmaceutical Statistical Sourcebook 2011/2012 By: Barnett Educational Services ... the latest intelligence on every aspect of biopharmaceutical development - from product discovery, to R&D performance and productivity, to time-to-market trends. With key analysis and contributions from leading consultancies and experts, the Sourcebook provides real-world ... \| more...	7/1/2011	$1,200.00
Medical Device Development: Regulation and Law By: Barnett Educational Services ... device and diagnostics development and approval requirements anywhere. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US. The new edition of ... \| more...	9/18/2009	$195.00
IND Submissions: A Primer By: Barnett Educational Services ... an IND. The book’s writing tips show regulatory professionals how to produce a range of U.S. drug and biologics submissions that comply with the requirements and are also clear to read. Included with the book ... \| more...	3/3/2009	$295.00
Glossary Acronyms for Clinical Research Professionals By: Barnett Educational Services ... than 900 key terms and over 500 acronyms that are commonly used in clinical research. This all-new edition has been expanded and includes terms and acronyms for: Clinical Research Pre-Clinical Research Regulatory Submissions Medical Devices ... \| more...	2/1/2009	$19.95
The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors By: Barnett Educational Services ... before participating in FDA-regulated clinical trials. And many of them may not truly appreciate the growing complexities involved in completing the mandatory form-and the implications for these researchers and study sponsors if they fail to ... \| more...	10/1/2008	$45.00
U.S. Regulatory Reporter By: Barnett Educational Services ... and drug development professionals at pharmaceutical, financial, legal, and related companies worldwide. From CANDAs to NDA Days, and from emerging drug access programs to innovative vehicles for drug export, the U.S. Regulatory Reporter covers the ... \| more...	7/1/2008	$395.00
The US Drug Approval Trends and Yearbook 2008/2009 By: Barnett Educational Services ... read edition, the new 2008/2009 edition examines hundreds of key trends and metrics to provide industry with all-new benchmarks and metrics on which to assess their own performance, to plan their own R&D projects, and ... \| more...	7/1/2008	$295.00
New Drug Development: A Regulatory Overview (8th Edition) By: Barnett Educational Services ... redefining how new drugs are developed and regulated today, including: How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements. How the CDER's efforts to integrate a "culture of ... \| more...	1/1/2008	$145.00
Expediting Drug and Biologics Development: A Strategic Approach 2006 By: Barnett Educational Services ... expedite even the most complex product development programs today! From the first preclinical testing to clinical trials to the NDA/BLA review, Expediting Drug and Biologics Development shows you how to use reverse-engineering techniques to drive ... \| more...	2/1/2006	$145.00
The Global GCP Compliance Report 2006: US, EU, and Japan By: Barnett Educational Services ... markets. Gain exclusive access to detailed data analyses of GCP compliance trends internationally, profiles of GCP compliance programs within several of the world's key regulatory agencies, and in-depth interviews with GCP compliance officials and GCP ... \| more...	1/1/2006	$95.00
Part 11 and Drug Development: A Q&A Reference Guide By: Barnett Educational Services ... worked their way into virtually every aspect of new drug development, so too have emerging and rapidly evolving Part 11 standards. Although the FDA's "new" Part 11 approach unveiled in late 2003 was seen as ... \| more...	3/1/2004	$24.95
Biologics Development: A Regulatory Overview 3rd Edition By: Barnett Educational Services ... to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A ... \| more...	3/1/2004	$145.00
HIPAA and Human Subjects Research: A Question & Answer Reference Guide By: Barnett Educational Services ... trial-related HIPAA regulations and guidance documents - and analysis and perspectives from the two leading HIPAA experts - all in one pocket-sized handbook! Learn how HIPAA will affect all aspects of clinical research --patient recruitment, ... \| more...	3/1/2003	$24.95
Medical Device Development: A Regulatory Overview By: Barnett Educational Services ... device approval program. Unlike other publications, this report goes beyond rehashes of device law and regulation to present "real world" strategic advice for expediting product clearances and dealing with the Center for Devices and Radiological ... \| more...	3/1/2000	$145.00
Partnerships in Clinical Trials: Pharmaceutical and Managed Care Alliances By: Barnett Educational Services ... fewer, more effective pivotal trials, thereby reducing their cost and time-to-market. At the same time, these studies allow manufacturers to collect data in the environment in which they'll be marketing, hopefully paving the way to ... \| more...	2/1/1998	$135.00
Global Biotechnology Product Registration: E.U., U.S., and Japan By: Barnett Educational Services ... medicines -- the U.S. E.U., and Japan. Within these three "prize" markets, historic and fundamental regulatory changes affecting biotechnology product regulation have been implemented recently. In the United States, the FDA has just implemented a ... \| more...	3/1/1997	$245.00
Title	Published	Price

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