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Specification of Drug Substances and Products

Specification of Drug Substances and Products
Development and Validation of Analytical Methods

by Christopher M. Riley,Thomas W. Rosanske,George L. Reid

  • Publisher : Elsevier
  • Release : 2020-07-23
  • Pages : 694
  • ISBN : 0081028253
  • Language : En, Es, Fr & De
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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

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
Regulations, Methodologies, and Best Practices

by Kim Huynh-Ba

  • Publisher : Springer Science & Business Media
  • Release : 2008-11-16
  • Pages : 389
  • ISBN : 0387856277
  • Language : En, Es, Fr & De
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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.

Pharmaceutical Stability Testing to Support Global Markets

Pharmaceutical Stability Testing to Support Global Markets
A Book

by Kim Huynh-Ba

  • Publisher : Springer Science & Business Media
  • Release : 2009-12-04
  • Pages : 266
  • ISBN : 9781441908896
  • Language : En, Es, Fr & De
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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 the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.

Early Drug Development

Early Drug Development
Strategies and Routes to First-in-Human Trials

by Mitchell N. Cayen

  • Publisher : John Wiley & Sons
  • Release : 2011-02-25
  • Pages : 654
  • ISBN : 9781118035207
  • Language : En, Es, Fr & De
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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 development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
Volume Three, Liquid Products

by Sarfaraz K. Niazi

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 400
  • ISBN : 1420081241
  • Language : En, Es, Fr & De
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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 details invo

Drug Benefits and Risks

Drug Benefits and Risks
International Textbook of Clinical Pharmacology

by Christoffel Jos van Boxtel,Budiono Santoso,I. Ralph Edwards

  • Publisher : IOS Press
  • Release : 2008-01-01
  • Pages : 821
  • ISBN : 158603880X
  • Language : En, Es, Fr & De
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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.

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis
A Book

by Satinder Ahuja,Stephen Scypinski

  • Publisher : Academic Press
  • Release : 2001
  • Pages : 566
  • ISBN : 9780120455553
  • Language : En, Es, Fr & De
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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 and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories. No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
Pharmaceutical Theory and Practice

by Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter

  • Publisher : Academic Press
  • Release : 2009-03-10
  • Pages : 978
  • ISBN : 9780080932729
  • Language : En, Es, Fr & De
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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 case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations
Forty-eighth Report

by WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization

  • Publisher : World Health Organization
  • Release : 2014
  • Pages : 387
  • ISBN : 9241209860
  • Language : En, Es, Fr & De
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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 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

Analytical Scientists in Pharmaceutical Product Development

Analytical Scientists in Pharmaceutical Product Development
Task Management and Practical Knowledge

by Kangping Xiao

  • Publisher : John Wiley & Sons
  • Release : 2020-10-06
  • Pages : 272
  • ISBN : 1119547822
  • Language : En, Es, Fr & De
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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, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment. 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, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment.

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations
Forty-first Report

by World Health Organization

  • Publisher : World Health Organization
  • Release : 2007
  • Pages : 156
  • ISBN : 9241209437
  • Language : En, Es, Fr & De
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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 procedures governing the assessment of pharmaceutical products for procurement by UN agencies and for assessing the acceptability of quality control laboratories. It also includes discussion regarding several monographs for inclusion in the International Pharmacopoeia, relating to antiretrovirals, including fixed-dose combinations, TB medicines and antimalarial and paediatric medicines.

Handbook of Preformulation

Handbook of Preformulation
Chemical, Biological, and Botanical Drugs

by Sarfaraz K. Niazi

  • Publisher : CRC Press
  • Release : 2006-09-18
  • Pages : 446
  • ISBN : 1420006622
  • Language : En, Es, Fr & De
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Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
A Practical Approach

by Walkiria S. Schlindwein,Mark Gibson

  • Publisher : John Wiley & Sons
  • Release : 2018-03-19
  • Pages : 368
  • ISBN : 1118895207
  • Language : En, Es, Fr & De
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A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

NMR Spectroscopy in Drug Development and Analysis

NMR Spectroscopy in Drug Development and Analysis
A Book

by Ulrike Holzgrabe,Iwona Wawer,Bernd Diehl

  • Publisher : John Wiley & Sons
  • Release : 2008-07-11
  • Pages : 312
  • ISBN : 352761365X
  • Language : En, Es, Fr & De
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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 3D structure of large molecules, especially biomolecules. However, NMR spectroscopy has been rarely applied to drug analysis. This book illustrates the power and versatility of NMR spectroscopy in the determination of impurities in and the content of drugs, the composition of polymer excipients, the characterization of isomeric drug mixtures, the complexity of drugs with small-size components or ions, and the behavior of drugs in acid and basic solution. In addition, NMR spectroscopy and especially the hyphenated technique with HPLC is shown to be a powerful tool to measure a drug and its metabolites in various body fluids. The solid state NMR technique can give information on the structure, especially the conformation of drugs and excipients in drug formulations. Recently, SAR by NMR, introduced by Fesik, impressively demonstrated the potential of NMR spectroscopy in drug development and in the characterization of the interaction between large molecules and ligands. The complexation between proteins, lipids and cyclodextrins with drugs is described. Finally, NMR imaging (MRI and MRS) can be used to characterize the liberation of drugs from a drug formulation. Furthermore, the distribution of substances in plants, in animals, in tissues and in humans can be visualized by imaging. In short, this book covers all aspects of drug analysis.

Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances

Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
A Book

by Anonim

  • Publisher : Unknown Publisher
  • Release : 1987
  • Pages : 60
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Pharmaceutical Preformulation and Formulation

Pharmaceutical Preformulation and Formulation
A Practical Guide from Candidate Drug Selection to Commercial Dosage Form

by Mark Gibson

  • Publisher : CRC Press
  • Release : 2016-04-19
  • Pages : 560
  • ISBN : 1420073184
  • Language : En, Es, Fr & De
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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 for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry. Topics include: Candidate drug selection Drug discovery and development Preformulation predictions and drug selections Product design to commercial dosage form Biopharmaceutical support in formulation Development The book is ideal for practitioners working in the pharmaceutical arena—including R&D scientists, technicians, and managers—as well as for undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology.

Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals

Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals
A Book

by Huss Ralf,Guenther Christine,Hauser Andrea Josefine

  • Publisher : World Scientific
  • Release : 2015-09-23
  • Pages : 564
  • ISBN : 981461680X
  • Language : En, Es, Fr & De
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This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies.This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity.

Capillary Electrophoresis Methods for Pharmaceutical Analysis

Capillary Electrophoresis Methods for Pharmaceutical Analysis
A Book

by Satinder Ahuja,Mohamedilias Jimidar

  • Publisher : Elsevier
  • Release : 2011-08-09
  • Pages : 546
  • ISBN : 0080559611
  • Language : En, Es, Fr & De
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Capillary electrophoresis (CE) is a powerful analytical technique that is widely used in research and development and in quality control of pharmaceuticals. Many reports of highly efficient separations and methods have been published over the past 15 years. CE offers several advantages over high-pressure or high-performance liquid chromatography (HPLC). These include simplicity, rapid analysis, automation, ruggedness, different mechanisms for selectivity, and low cost. Moreover, EC requires smaller sample size and yet offers higher efficiency and thus greater resolution power over HPLC. These characteristics are very attractive in research and development, even more so in pharmaceutical quality control (QC) and stability monitoring (SM) studies. This book will provide busy pharmaceutical scientists a complete yet concise reference guide for utilizing the versatility of CE in new drug development and quality control. - Provides current status and future developments in CE analysis of pharmaceuticals. - Explains how to develop and validate methods. - Includes major pharmaceutical applications including assays and impurity testing.

Long Acting Animal Health Drug Products

Long Acting Animal Health Drug Products
Fundamentals and Applications

by Michael J. Rathbone,Arlene McDowell

  • Publisher : Springer Science & Business Media
  • Release : 2012-10-12
  • Pages : 392
  • ISBN : 146144439X
  • Language : En, Es, Fr & De
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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 challenges when innovating new products in this demanding field of controlled release. This book provides the reader with a comprehensive guide on the theories, applications, and challenges associated with the design and development of long acting veterinary formulations. The authoritative chapters of the book are written by some of the leading experts in the field. The book covers a wide scope of areas including the market influences, preformulation, biopharmaceutics, in vitro drug release testing and specification setting to name but a few. It also provides a detailed overview of the major technological advances made in this area. As a result this book covers everything a formulation scientist in industry or academia, or a student needs to know about this unique drug delivery field to advance health, production and reproduction treatment options and benefits for animals worldwide.

Quantitative Methods for Traditional Chinese Medicine Development

Quantitative Methods for Traditional Chinese Medicine Development
A Book

by Shein-Chung Chow

  • Publisher : CRC Press
  • Release : 2015-12-01
  • Pages : 430
  • ISBN : 1498766889
  • Language : En, Es, Fr & De
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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 the first book entirely devoted to the design and analysis of TCM development from a Western perspective, i.e., evidence-based clinical research and development. The book provides not only a comprehensive summary of innovative quantitative methods for developing TCMs but also a useful desk reference for principal investigators involved in personalized medicine. Written by one of the world’s most prominent biostatistics researchers, the book connects the pharmaceutical industry, regulatory agencies, and academia. It presents a state-of-the-art examination of the subject for: Scientists and researchers who are engaged in pharmaceutical/clinical research and development of TCMs Those in regulatory agencies who make decisions in the review and approval process of TCM regulatory submissions Biostatisticians who provide statistical support to assess clinical safety and effectiveness of TCMs and related issues regarding quality control and assurance as well as to test for consistency in the manufacturing processes for TCMs This book covers all of the statistical issues encountered at various stages of pharmaceutical/clinical development of a TCM. It explains regulatory requirements; product specifications and standards; and various statistical techniques for evaluation of TCMs, validation of diagnostic procedures, and testing consistency. It also contains an entire chapter of case studies and addresses critical issues in TCM development and FAQs from a regulatory perspective.