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Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
Language: en
Pages: 704

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Authors: Carmen Medina
Categories: Medical
Type: BOOK - Published: 2003-12-09 - Publisher: CRC Press

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
Language: en
Pages: 704

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Authors: Carmen Medina
Categories: Medical
Type: BOOK - Published: 2003-12-09 - Publisher: CRC Press

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating
FDA Regulatory Affairs
Language: en
Pages: 360

FDA Regulatory Affairs

Authors: Douglas J. Pisano
Categories: Medical
Type: BOOK - Published: 2003-12-23 - Publisher: CRC Press

Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navig
Cost-Contained Regulatory Compliance
Language: en
Pages: 296

Cost-Contained Regulatory Compliance

Authors: Sandy Weinberg
Categories: Medical
Type: BOOK - Published: 2011-04-18 - Publisher: John Wiley & Sons

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. Thi
CAPA in the Pharmaceutical and Biotech Industries
Language: en
Pages: 248

CAPA in the Pharmaceutical and Biotech Industries

Authors: J Rodriguez
Categories: Medical
Type: BOOK - Published: 2015-12-08 - Publisher: Elsevier

CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, de
Dermal Absorption and Toxicity Assessment, Second Edition
Language: en
Pages: 678

Dermal Absorption and Toxicity Assessment, Second Edition

Authors: Michael S. Roberts
Categories: Medical
Type: BOOK - Published: 2008 - Publisher: CRC Press

The source Dermal Absorption and Toxicity Assessment supplies a state-of-the-art overview of the dermal absorption process, and is divided into six well organiz
FDA Regulatory Affairs
Language: en
Pages: 400

FDA Regulatory Affairs

Authors: David Mantus
Categories: Medical
Type: BOOK - Published: 2014-02-28 - Publisher: CRC Press

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise
Modern Pharmaceutics
Language: en
Pages: 537

Modern Pharmaceutics

Authors: Alexander Taylor Florence
Categories: Medical
Type: BOOK - Published: 2009 - Publisher: CRC Press

Modern Pharmaceutics examines the impact of pharmaceutical biotechnology, cell therapy, pharmacogenomics (biotherapeutics), and nanotechnology on current practi
Generic Drug Product Development
Language: en
Pages: 264

Generic Drug Product Development

Authors: Isadore Kanfer
Categories: Business & Economics
Type: BOOK - Published: 2008 - Publisher: CRC Press

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Gene
The Certified Pharmaceutical GMP Professional Handbook, Second Edition
Language: en
Pages: 516

The Certified Pharmaceutical GMP Professional Handbook, Second Edition

Authors: Mark Allen Durivage
Categories: Business & Economics
Type: BOOK - Published: 2016-05-26 - Publisher: Quality Press

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide