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Pharmaceutical Project Management, Second Edition
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Encompassing the full spectrum of project management’s role and responsibility encountered in the pharmaceutical industry, Pharmaceutical Project Management outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through manufacturing and launch. Download Link:
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Posted in books by kdsaggi on Aug. 07, 2008 // 08:16
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Establishing A CGMP Laboratory Audit System: A Practical Guide
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The first systematic, hands-on auditing guide for today's pharmaceutical laboratories
In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to:
* Improve current compliance
* Demonstrate sustainable compliance
* Produce data for federal inspections
* Avoid regulatory action
This book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory.
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Posted in books by kdsaggi on Aug. 07, 2008 // 08:17
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Laboratory Animal Law: Legal Control of the Use of Animals in Research
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“It is hard to see how anyone with responsibilities under the Animals (Scientific Procedures) Act could
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Posted in books by kdsaggi on Aug. 07, 2008 // 08:19
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Neonatal Formulary: Drug Use in Pregnancy and the First Year of Life
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The Neonatal Formulary is a unique
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Posted in books by kdsaggi on Aug. 07, 2008 // 08:19
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The Hands-on Guide to Practical Prescribing
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The hands-on guide to practical prescribing is a concise, easy-to-use guide to the practical aspects of pharmacology for junior doctors who are making the transition from studying pharmacology to prescribing drugs for the
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Posted in books by kdsaggi on Aug. 07, 2008 // 09:29
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Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Patkage Integrity Testing: Third Edition
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Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the
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Posted in books by kdsaggi on Aug. 07, 2008 // 09:30
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Handbook of Pharmaceutical Granulation Technology, Second Edition
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Applying basic theories to industrial practices in pharmaceutical development, this Second Edition explains how new and emerging technologies are utilized in the production of pharmaceutical granulation-demonstrating cost-effective strategies to manufacture solid-dosage forms with consistent physical properties while complying with current regulatory requirements. New chapters cover process modeling, scale-up considerations, rapid release granulation techniques, melt granulation and pelletization, effervescent granulation, rapid release, and process analytical technology. Updated sections cover the theory of granulation from an engineering perspective and the regulatory standards.
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Posted in books by kdsaggi on Aug. 07, 2008 // 09:44
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