Specification of Drug Substances and Products

Written By Christopher M. Riley
Specification of Drug Substances and Products
  • Publsiher : Elsevier
  • Release : 23 July 2020
  • ISBN : 0081028253
  • Pages : 694 pages
  • Rating : 5/5 from 1 reviews
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Read or download book entitled Specification of Drug Substances and Products written by Christopher M. Riley which was release on 23 July 2020, this book published by Elsevier. Available in PDF, EPUB and Kindle Format. Book excerpt: Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories. Presents a critical assessment of the application of ICH guidelines on method validation and specification setting Written by subject-matter experts involved in the development and application of the guidelines Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction

Specification of Drug Substances and Products

Specification of Drug Substances and Products
  • Author : Christopher M. Riley,Thomas W. Rosanske,George L. Reid
  • Publisher : Elsevier
  • Release Date : 2020-07-23
  • Total pages : 694
  • ISBN : 0081028253
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Summary : Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised ...

Specification of Drug Substances and Products

Specification of Drug Substances and Products
  • Author : Christopher M. Riley,Thomas W. Rosanske,Shelley R. Rabel Riley
  • Publisher : Elsevier
  • Release Date : 2016-06
  • Total pages : 390
  • ISBN : 0081028253
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Summary : "Specification of Drug Substances and Products: Development and Validation of Analytical Methods" is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review ...

New Drug Development

New Drug Development
  • Author : Mark P. Mathieu,Anne G. Evans,Parexel International Corporation
  • Publisher : Parexel International Corporation
  • Release Date : 1997
  • Total pages : 358
  • ISBN : 0081028253
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Summary : Download or read online New Drug Development written by Mark P. Mathieu,Anne G. Evans,Parexel International Corporation, published by Parexel International Corporation which was released on 1997. Get New Drug Development Books now! Available in PDF, ePub and Kindle....

Food Drug Cosmetic Law Reporter

Food  Drug  Cosmetic Law Reporter
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1963
  • Total pages : 212
  • ISBN : 0081028253
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Summary : Download or read online Food Drug Cosmetic Law Reporter written by , published by which was released on 1963. Get Food Drug Cosmetic Law Reporter Books now! Available in PDF, ePub and Kindle....

Handbook of Pharmaceutical Analysis by HPLC

Handbook of Pharmaceutical Analysis by HPLC
  • Author : Satinder Ahuja,Michael Dong
  • Publisher : Elsevier
  • Release Date : 2005-02-09
  • Total pages : 600
  • ISBN : 0081028253
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Summary : High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise ...

Handbook of Pharmaceutical Manufacturing Formulations Third Edition

Handbook of Pharmaceutical Manufacturing Formulations  Third Edition
  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release Date : 2019-12-09
  • Total pages : 416
  • ISBN : 0081028253
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Summary : The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug ...

NMR in Pharmaceutical Science

NMR in Pharmaceutical Science
  • Author : Jeremy R. Everett,Robin K. Harris,John C. Lindon,Ian D. Wilson
  • Publisher : John Wiley & Sons
  • Release Date : 2015-08-20
  • Total pages : 504
  • ISBN : 0081028253
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Summary : NMR in Pharmaceutical Sciences is intended to be a comprehensive source of information for the many individuals that utilize MR in studies of relevance to the pharmaceutical sector. The book is intended to educate and inform those who develop and apply MR approaches within the wider pharmaceutical environment, emphasizing the ...

Export Marketing Strategy for Herbal Products and Ayurvedic Drugs

Export Marketing Strategy for Herbal Products and Ayurvedic Drugs
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2007
  • Total pages : 150
  • ISBN : 0081028253
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Summary : Download or read online Export Marketing Strategy for Herbal Products and Ayurvedic Drugs written by , published by which was released on 2007. Get Export Marketing Strategy for Herbal Products and Ayurvedic Drugs Books now! Available in PDF, ePub and Kindle....

The Rules Governing Medicinal Products in the European Community Guidelines on the quality safety and efficacy of medicinal products for human use

The Rules Governing Medicinal Products in the European Community  Guidelines on the quality  safety and efficacy of medicinal products for human use
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1989
  • Total pages : 212
  • ISBN : 0081028253
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Summary : EEC regulations for the marketing, production, and distribution of pharmaceutical products to safeguard public health. Also includes the controls on manufacturing and labeling of drugs....

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules
  • Author : Behnam Davani
  • Publisher : John Wiley & Sons
  • Release Date : 2017-08-14
  • Total pages : 256
  • ISBN : 0081028253
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Summary : A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits ...

Proceedings of Biomedical Applications of Raman Spectroscopy

Proceedings of Biomedical Applications of Raman Spectroscopy
  • Author : Michael D. Morris
  • Publisher : Society of Photo Optical
  • Release Date : 1999
  • Total pages : 250
  • ISBN : 0081028253
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Summary : Download or read online Proceedings of Biomedical Applications of Raman Spectroscopy written by Michael D. Morris, published by Society of Photo Optical which was released on 1999. Get Proceedings of Biomedical Applications of Raman Spectroscopy Books now! Available in PDF, ePub and Kindle....

Library Information Science Abstracts

Library   Information Science Abstracts
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2003
  • Total pages : 212
  • ISBN : 0081028253
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Summary : Download or read online Library Information Science Abstracts written by , published by which was released on 2003. Get Library Information Science Abstracts Books now! Available in PDF, ePub and Kindle....

Herbal Medicinal Products

Herbal Medicinal Products
  • Author : Frauke Gaedcke,Barbara Steinhoff,Helga Blasius
  • Publisher : Unknown
  • Release Date : 2003
  • Total pages : 177
  • ISBN : 0081028253
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Summary : European legislation requires herbal medicinal products (HMPs) to meet strict standards of quality, safety and efficacy. In Europe and worldwide, HPMs play an important role both in self-medication and in medical practice. Book jacket....

Proceedings of the first International Conference on Harmonisation

Proceedings of the first International Conference on Harmonisation
  • Author : Patrick Francis D'Arcy,D. W. G. Harron
  • Publisher : Unknown
  • Release Date : 1992
  • Total pages : 590
  • ISBN : 0081028253
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Summary : Download or read online Proceedings of the first International Conference on Harmonisation written by Patrick Francis D'Arcy,D. W. G. Harron, published by which was released on 1992. Get Proceedings of the first International Conference on Harmonisation Books now! Available in PDF, ePub and Kindle....

Drug Safety Evaluation

Drug Safety Evaluation
  • Author : Shayne C. Gad
  • Publisher : Wiley-Interscience
  • Release Date : 2002-04-18
  • Total pages : 1007
  • ISBN : 0081028253
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Summary : Covers the scientific and philosophical bases for evaluation of specific concerns, such as carcinogenicity and development toxicity....