Pharmaceutical Process Validation Second Edition

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Pharmaceutical Process Validation Second Edition

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Author : Ira R. Berry
language : en
Publisher: CRC Press
Release Date : 1993-01-29

Pharmaceutical Process Validation Second Edition written by Ira R. Berry and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993-01-29 with Medical categories.

The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.

Handbook Of Pharmaceutical Analysis

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Author : Lena Ohannesian
language : en
Publisher: CRC Press
Release Date : 2001-11-09

Handbook Of Pharmaceutical Analysis written by Lena Ohannesian and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-11-09 with Medical categories.

Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.

Transport Processes In Pharmaceutical Systems

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Author : Gordon L. Amidon
language : en
Publisher: CRC Press
Release Date : 1999-11-24

Transport Processes In Pharmaceutical Systems written by Gordon L. Amidon and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-11-24 with Science categories.

This cutting-edge reference clearly explains pharmaceutical transport phenomena, demonstrating applications ranging from drug or nutrient uptake into vesicle or cell suspensions, drug dissolution and absorption across biological membranes, whole body kinetics, and drug release from polymer reservoirs and matrices to heat and mass transport in freeze-drying and hygroscopicity. Focuses on practical applications of drug delivery from a physical and mechanistic perspective, highlighting biological systems. Written by more than 30 international authorities in the field, Transport Processes in Pharmaceutical Systems discusses the crucial relationship between the transport process and thermodynamic factors analyzes the dynamics of diffusion at liquid-liquid, liquid-solid, and liquid-cultured cell interfaces covers prodrug design for improving membrane transport addresses the effects of external stimuli in altering some natural and synthetic polymer matrices examines properties of hydrogels, including synthesis, swelling degree, swelling kinetics, permeability, biocompatibility, and biodegradability presents mass transfer of drugs and pharmacokinetics based on mass balance descriptions and more! Containing over 1000 references and more than 1100 equations, drawings, photographs, micrographs, and tables, Transport Processes in Pharmaceutical Systems is a must-read resource for research pharmacists, pharmaceutical scientists and chemists, chemical engineers, physical chemists, and upper-level undergraduate and graduate students in these disciplines.

Generic Drug Product Development

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Author : Isadore Kanfer
language : en
Publisher: CRC Press
Release Date : 2007-11-15

Generic Drug Product Development written by Isadore Kanfer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-11-15 with Medical categories.

The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important comp

Good Manufacturing Practices For Pharmaceuticals

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Author : Joseph D. Nally
language : en
Publisher: CRC Press
Release Date : 2016-04-19

Good Manufacturing Practices For Pharmaceuticals written by Joseph D. Nally and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

Development And Formulation Of Veterinary Dosage Forms

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Author : Gregory E. Hardee
language : en
Publisher: CRC Press
Release Date : 2021-04-30

Development And Formulation Of Veterinary Dosage Forms written by Gregory E. Hardee and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-04-30 with Medical categories.

Although the United States (U.S.) and the more developed nations of the remainder of the world are blessed with a variety of pharmaceuticals, feed additives, and biological products to treat, prevent, and control animal diseases, there is a healthy desire among persons involved in animal health issues to increase our animal medicine chest. The interest stems from the desire to efficiently produce food that is safe and plentiful and from the desire to have more and better government-approved products available for the prevention and treatment of diseases of dogs, cats, and horses and for an increasing variety of minor animal species. For the animal health industry, increased drug availability means broader markets, increased revenues, and an opportunity to better serve their customers. For the veterinarian, more animal health products means that he or she is better able to treat the usual and the unusual conditions, and to prevent animal disease and suffering. No doubt, we are all winners when new technology and industrial and regulatory initiatives hasten the availability of safe and effective animal health products.

Good Laboratory Practice Regulations

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Author : Sandy Weinberg
language : en
Publisher: CRC Press
Release Date : 2007-01-19

Good Laboratory Practice Regulations written by Sandy Weinberg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-01-19 with Medical categories.

Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse

Environmental Monitoring For Cleanrooms And Controlled Environments

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Author : Anne Marie Dixon
language : en
Publisher: CRC Press
Release Date : 2016-04-19

Environmental Monitoring For Cleanrooms And Controlled Environments written by Anne Marie Dixon and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.

A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response

Dermal Absorption And Toxicity Assessment

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Author : Michael S. Roberts
language : en
Publisher: CRC Press
Release Date : 2007-12-14

Dermal Absorption And Toxicity Assessment written by Michael S. Roberts and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-12-14 with Medical categories.

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 organized sections. Written by internationally recognized experts in the field, this Second Edition is a complete revised and updated text, covering the wide range of methods used to assess skin ab

Pharmaceutical Process Validation

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Author : Bernard T. Loftus
language : en
Publisher: Marcel Dekker
Release Date : 1984

Pharmaceutical Process Validation written by Bernard T. Loftus and has been published by Marcel Dekker this book supported file pdf, txt, epub, kindle and other format this book has been release on 1984 with Business & Economics categories.