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- Specification of Drug Substances and Products
- Author : Christopher M. Riley
- 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
- 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 ...
- Author : Kim Huynh-Ba
- Publisher : Springer Science & Business Media
- Release Date : 2009-12-04
- Total pages : 266
- ISBN : 0081028253
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Summary : The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in ...
- Author : Mitchell N. Cayen
- Publisher : John Wiley & Sons
- Release Date : 2011-02-25
- Total pages : 654
- ISBN : 0081028253
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Summary : The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical ...
- Author : Seshadri Neervannan,Uday B. Kompella
- Publisher : Springer Nature
- Release Date : 2022-03-11
- Total pages : 650
- ISBN : 0081028253
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Summary : This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use. Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product development. The coverage encompasses topical and intraocular formulations, small molecules and ...
- Author : Sarfaraz K. Niazi
- Publisher : CRC Press
- Release Date : 2016-04-19
- Total pages : 400
- ISBN : 0081028253
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Summary : While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages.Highlights from Liquid Products, Volume Three include:practical ...
- 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 ...
- 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 ...
- Author : Christoffel Jos van Boxtel,Budiono Santoso,I. Ralph Edwards
- Publisher : IOS Press
- Release Date : 2008-01-01
- Total pages : 821
- ISBN : 0081028253
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Summary : Explores the scientific basis and practice of drug therapy. This book examines the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world. It covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases....
- 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 ...
- Author : World Health Organization
- Publisher : World Health Organization
- Release Date : 2007
- Total pages : 156
- ISBN : 0081028253
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Summary : This report sets out the recommendations of an international group of experts relating to developments in the quality assurance of medicines and specifications for drug substances and dosage forms. It contains guidelines of direct relevance to the UN Prequalification Programme for Priority Essential Medicines and for quality control laboratories, including ...
- 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, ...
- Author : Hong Wen,Kinam Park
- Publisher : John Wiley & Sons
- Release Date : 2011-01-14
- Total pages : 376
- ISBN : 0081028253
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Summary : This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and ...
- Author : Mark Gibson
- Publisher : CRC Press
- Release Date : 2016-04-19
- Total pages : 560
- ISBN : 0081028253
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Summary : Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the need ...
- 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...
- Author : Michael J. Rathbone,Arlene McDowell
- Publisher : Springer Science & Business Media
- Release Date : 2012-10-12
- Total pages : 392
- ISBN : 0081028253
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Summary : Long acting veterinary formulations play a significant role in animal health, production and reproduction within the animal health industry. Such technologies offer beneficial advantages to the veterinarian, farmer and pet owner. These advantages have resulted in them growing in popularity in recent years. The pharmaceutical scientist is faced with many ...
