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Specification of Drug Substances and Products

Specification of Drug Substances and Products
  • Author : Christopher M. Riley,Thomas W. Rosanske,George L. Reid
  • Publisher :Unknown
  • Release Date :2020-07-23
  • Total pages :694
  • ISBN : 9780081028254
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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 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

Development and Validation of Analytical Methods

Development and Validation of Analytical Methods
  • Author : Christopher M. Riley,Thomas W. Rosanske
  • Publisher :Unknown
  • Release Date :1996-05-29
  • Total pages :349
  • ISBN : 0080530354
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Summary : The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

Specification of Drug Substances and Products

Specification of Drug Substances and Products
  • Author : Christopher M. Riley,Thomas W. Rosanske,Shelley R. Rabel Riley
  • Publisher :Unknown
  • Release Date :2016-06
  • Total pages :390
  • ISBN : 0081013132
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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 of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them. Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authoritiesDirect applicability to the day-to-day activities in drug development and the potential to increase productivity

ICH Quality Guidelines

ICH Quality Guidelines
  • Author : Andrew Teasdale,David Elder,Raymond W. Nims
  • Publisher :Unknown
  • Release Date :2017-10-09
  • Total pages :736
  • ISBN : 9781118971116
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Summary : Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Pharmaceutical Analysis for Small Molecules

Pharmaceutical Analysis for Small Molecules
  • Author : Behnam Davani
  • Publisher :Unknown
  • Release Date :2017-08-14
  • Total pages :256
  • ISBN : 9781119121114
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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 find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

Frontiers in Statistical Quality Control 8

Frontiers in Statistical Quality Control 8
  • Author : Hans-Joachim Lenz,Peter-Theodor Wilrich
  • Publisher :Unknown
  • Release Date :2006
  • Total pages :351
  • ISBN : UOM:39015064917605
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Summary : This volume treats the three main categories of Statistical Quality Control: General Aspects of SQC Methodology, On-line Control including Sampling Plans, Control Charts and Monitoring, and Off-line Control including Data Analysis, Calibration and Experimental Design. Experts with international reputation present their newest contributions.

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
  • Author : Kim Huynh-Ba
  • Publisher :Unknown
  • Release Date :2008-11-16
  • Total pages :389
  • ISBN : 9780387856278
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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.

International Stability Testing

International Stability Testing
  • Author : David J. Mazzo
  • Publisher :Unknown
  • Release Date :2020-08-27
  • Total pages :352
  • ISBN : 9781000161663
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Summary : In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.

Pharmaceutical Stability Testing to Support Global Markets

Pharmaceutical Stability Testing to Support Global Markets
  • Author : Kim Huynh-Ba
  • Publisher :Unknown
  • Release Date :2009-12-04
  • Total pages :266
  • ISBN : 1441908897
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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 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.

Handbook of Pharmaceutical Manufacturing Formulations

Handbook of Pharmaceutical Manufacturing Formulations
  • Author : Safaraz K. Niazi
  • Publisher :Unknown
  • Release Date :2016-04-19
  • Total pages :464
  • ISBN : 9781420081312
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Summary : No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing ster

Handbook of Analytical Validation

Handbook of Analytical Validation
  • Author : Michael E. Swartz,Ira S. Krull
  • Publisher :Unknown
  • Release Date :2012-04-24
  • Total pages :220
  • ISBN : 9781420014488
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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

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
  • Author : John Geigert
  • Publisher :Unknown
  • Release Date :2012-12-06
  • Total pages :350
  • ISBN : 9781441991317
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Summary : "The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.

Analytical Profiles of Drug Substances

Analytical Profiles of Drug Substances
  • Author : Klaus Florey
  • Publisher :Unknown
  • Release Date :1988
  • Total pages :229
  • ISBN : 0122608119
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Summary :

Federal Register

Federal Register
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1997-11-25
  • Total pages :229
  • ISBN : UIUC:30112059133832
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Summary :

Photostability of Drugs and Drug Formulations, Second Edition

Photostability of Drugs and Drug Formulations, Second Edition
  • Author : Hanne Hjorth Tonnesen
  • Publisher :Unknown
  • Release Date :2004-06-29
  • Total pages :448
  • ISBN : 1420023594
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Summary : Providing the guidance needed for formulation, handling, and quality control of photolabile drugs, Photostability of Drugs and Drug Formulations, Second Edition explores the significance of new information on drug photoreactivity in a pharmaceutical context. Completely revised and updated, with chapter authors drawn from an international panel of experts, the book supplies the background necessary for planning standardized photochemical stability studies as a part of drug development and formulation work. It contains comprehensive coverage of the physical and chemical aspects of drug photoreactivity, formulation, stability testing, and drug design/discovery in one resource. The contents have been reorganized to focus on the standardization of photostability testing of drug substances and products, in vitro photoreactivity screening of drugs, and various aspects of the formulation of photoreactive substances. The information on in vitro screening of drug photoreactivity is of great relevance for scientists who are developing and validating a set of testing protocols to address photosafety. Discussing kinetic and chemical aspects of drug photodecomposition as well as the practical problems frequently encountered in photochemical stability testing, this book helps you design a test protocol and interpret the results. Features Assists non-experts in this field design a test protocol and interpret the results Covers in vitro and in vivo aspects of interactions between drugs and light Explores the kinetic and chemical aspects of drug photodecomposition Discusses the problems frequently encountered in photochemical stability testing Provides guidance on how to address photosafety assessments and labeling requirements of potentially photoreactive drugs Highlights the practical implications of drug photodecomposition from a pharmaceutical viewpoint Offers specific guidance in photostability testing and screening of drug photoreactivity

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
  • Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
  • Publisher :Unknown
  • Release Date :2009-03-10
  • Total pages :978
  • ISBN : 008093272X
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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 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

Pharmaceutical Stability Testing to Support Global Markets

Pharmaceutical Stability Testing to Support Global Markets
  • Author : Kim Huynh-Ba
  • Publisher :Unknown
  • Release Date :2009-12-04
  • Total pages :266
  • ISBN : 1441908897
GET BOOK HERE

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 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.

The International Pharmacopoeia. -- 1981-

The International Pharmacopoeia. -- 1981-
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1981
  • Total pages :229
  • ISBN : OCLC:1200942005
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Summary :

Statistical Tolerance Regions

Statistical Tolerance Regions
  • Author : Kalimuthu Krishnamoorthy,Thomas Mathew
  • Publisher :Unknown
  • Release Date :2009-05-06
  • Total pages :512
  • ISBN : 0470473894
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Summary : A modern and comprehensive treatment of tolerance intervals and regions The topic of tolerance intervals and tolerance regions has undergone significant growth during recent years, with applications arising in various areas such as quality control, industry, and environmental monitoring. Statistical Tolerance Regions presents the theoretical development of tolerance intervals and tolerance regions through computational algorithms and the illustration of numerous practical uses and examples. This is the first book of its kind to successfully balance theory and practice, providing a state-of-the-art treatment on tolerance intervals and tolerance regions. The book begins with the key definitions, concepts, and technical results that are essential for deriving tolerance intervals and tolerance regions. Subsequent chapters provide in-depth coverage of key topics including: Univariate normal distribution Non-normal distributions Univariate linear regression models Nonparametric tolerance intervals The one-way random model with balanced data The multivariate normal distribution The one-way random model with unbalanced data The multivariate linear regression model General mixed models Bayesian tolerance intervals A final chapter contains coverage of miscellaneous topics including tolerance limits for a ratio of normal random variables, sample size determination, reference limits and coverage intervals, tolerance intervals for binomial and Poisson distributions, and tolerance intervals based on censored samples. Theoretical explanations are accompanied by computational algorithms that can be easily replicated by readers, and each chapter contains exercise sets for reinforcement of the presented material. Detailed appendices provide additional data sets and extensive tables of univariate and multivariate tolerance factors. Statistical Tolerance Regions is an ideal book for courses on tolerance intervals at the graduate level. It is also a valuable reference and resource for applied statisticians, researchers, and practitioners in industry and pharmaceutical companies.

Special Topics in Drug Discovery

Special Topics in Drug Discovery
  • Author : Taosheng Chen,Sergio Chai
  • Publisher :Unknown
  • Release Date :2016-11-30
  • Total pages :190
  • ISBN : 9789535127994
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Summary : Drug discovery involves multiple disciplines, technologies, and approaches. This book selects important topics related to drug discovery, including emerging tool (Chapter 1), cutting-edge approaches (Chapters 2, 3, and 4), examples of specific therapeutic area (Chapter 5), quality control in drug development (Chapter 6), and job and career opportunities in the pharmaceutical sector, a topic rarely covered by other books (Chapter 7). This book draws knowledge from experts actively involved in different areas of drug discovery from both industrial and academic settings. We hope that this book will facilitate your efforts in drug discovery.

Countering the Problem of Falsified and Substandard Drugs

Countering the Problem of Falsified and Substandard Drugs
  • Author : Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products
  • Publisher :Unknown
  • Release Date :2013-06-20
  • Total pages :376
  • ISBN : 9780309269391
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Summary : The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.