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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Download or read book entitled Specification of Drug Substances and Products by author: Christopher M. Riley which was release on 23 July 2020 and published by Elsevier with total page 694 pages . This book available in PDF, EPUB and Kindle Format. 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 Science Limited
  • Release Date : 2013-09
  • Total pages : 380
  • 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 ...

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
  • Author : Kim Huynh-Ba
  • Publisher : Springer Science & Business Media
  • Release Date : 2008-11-16
  • Total pages : 389
  • ISBN : 0081028253
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Summary : This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices....

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis
  • Author : Satinder Ahuja,Stephen Scypinski
  • Publisher : Academic Press
  • Release Date : 2001
  • Total pages : 566
  • ISBN : 0081028253
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Summary : This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry ...

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
  • Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
  • Publisher : Academic Press
  • Release Date : 2009-03-10
  • Total pages : 978
  • ISBN : 0081028253
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Summary : Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or ...

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations
  • Author : WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization
  • Publisher : World Health Organization
  • Release Date : 2014
  • Total pages : 387
  • ISBN : 0081028253
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Summary : The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 ...

Analytical Scientists in Pharmaceutical Product Development

Analytical Scientists in Pharmaceutical Product Development
  • Author : Kangping Xiao
  • Publisher : John Wiley & Sons
  • Release Date : 2020-10-06
  • Total pages : 272
  • ISBN : 0081028253
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Summary : This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, ...

Pharmaceutical Dosage Forms Parenteral Medications

Pharmaceutical Dosage Forms   Parenteral Medications
  • Author : Sandeep Nema,John D. Ludwig
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • Total pages : 318
  • ISBN : 0081028253
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Summary : This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacture of parenteral dosage forms, effectively balancing theoretical considerations with the practical aspects of their development. As such, it is recommended for scientists and engineers in the pharmaceutical industry and academia, ...

Handbook of Pharmaceutical Manufacturing Formulations Third Edition

Handbook of Pharmaceutical Manufacturing Formulations  Third Edition
  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release Date : 2019-12-05
  • Total pages : 420
  • ISBN : 0081028253
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Summary : The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid 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 third volume of a six-volume set, compiles data from FDA and EMA new drug ...

NMR Spectroscopy in Drug Development and Analysis

NMR Spectroscopy in Drug Development and Analysis
  • Author : Ulrike Holzgrabe,Iwona Wawer,Bernd Diehl
  • Publisher : John Wiley & Sons
  • Release Date : 2008-07-11
  • Total pages : 312
  • ISBN : 0081028253
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Summary : Since the development of the NMR spectrometer in the 1950s, NMR spectra have been widely used for the elucidation of the 2D structure of newly synthesized and natural compounds. In the 1980s, the high-resolution NMR spectrometer (> 300 Mhz) and 2D experiments were introduced, which opens up the possibility to determine the 3...

Handbook of Analytical Validation

Handbook of Analytical Validation
  • Author : Michael E. Swartz,Ira S. Krull
  • Publisher : CRC Press
  • Release Date : 2012-04-24
  • Total pages : 220
  • ISBN : 0081028253
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Summary : Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:Contains practical, up-to-date guidelines for analyti...

Quantitative Methods for Traditional Chinese Medicine Development

Quantitative Methods for Traditional Chinese Medicine Development
  • Author : Shein-Chung Chow
  • Publisher : CRC Press
  • Release Date : 2015-12-01
  • Total pages : 430
  • ISBN : 0081028253
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Summary : A Western-Based Approach to Analyzing TCMs In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is ...

Manufacturing of Pharmaceutical Proteins

Manufacturing of Pharmaceutical Proteins
  • Author : Stefan Behme
  • Publisher : John Wiley & Sons
  • Release Date : 2015-03-20
  • Total pages : 456
  • ISBN : 0081028253
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Summary : Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical ...

Encyclopedia of Biopharmaceutical Statistics Four Volume Set

Encyclopedia of Biopharmaceutical Statistics   Four Volume Set
  • Author : Shein-Chung Chow
  • Publisher : CRC Press
  • Release Date : 2018-09-03
  • Total pages : 2780
  • ISBN : 0081028253
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Summary : Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of ...

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules
  • Author : Behnam Davani
  • Publisher : John Wiley & Sons
  • Release Date : 2017-07-12
  • 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 ...