Analytical Methods For Drug Development
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Analytical Techniques In The Pharmaceutical Sciences
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Author : Anette Müllertz
language : en
Publisher: Springer
Release Date : 2016-08-30
Analytical Techniques In The Pharmaceutical Sciences written by Anette Müllertz and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-30 with Medical categories.
The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.
Analytical Methods For Drug Development
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Author : Dr. Sumithra M
language : en
Publisher: ThinkPlus Pharma Publications
Release Date : 2025-04-16
Analytical Methods For Drug Development written by Dr. Sumithra M and has been published by ThinkPlus Pharma Publications this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-04-16 with Medical categories.
This textbook offers a practical approach to understanding analytical methods in drug development. Written for students, researchers, and industry professionals, it bridges fundamental concepts with real-world applications. The book covers essential techniques from early-stage drug discovery through manufacturing, incorporating current regulatory standards and industry practices. Each chapter builds analytical knowledge through practical examples, case studies, and detailed protocols. Whether you're studying pharmacy, working in quality control, or conducting research, this guide provides the tools needed to master modern pharmaceutical analysis and implement effective analytical strategies in drug development.
Specification Of Drug Substances And Products
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Author : Christopher M. Riley
language : en
Publisher: Elsevier
Release Date : 2020-07-23
Specification Of Drug Substances And Products written by Christopher M. Riley and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-07-23 with Science categories.
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
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Author : Christopher M. Riley
language : en
Publisher: Elsevier
Release Date : 1996-05-29
Development And Validation Of Analytical Methods written by Christopher M. Riley and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996-05-29 with Science categories.
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.
Analytical Method Development And Validation
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Author : Michael E. Swartz
language : en
Publisher: CRC Press
Release Date : 2018-10-03
Analytical Method Development And Validation written by Michael E. Swartz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-03 with Science categories.
Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Formulation And Analytical Development For Low Dose Oral Drug Products
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Author : Jack Zheng
language : en
Publisher: John Wiley & Sons
Release Date : 2009-03-04
Formulation And Analytical Development For Low Dose Oral Drug Products written by Jack Zheng and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-04 with Medical categories.
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
Separation Methods In Drug Synthesis And Purification
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Author : Klara Valko
language : en
Publisher: Elsevier
Release Date : 2000-10-13
Separation Methods In Drug Synthesis And Purification written by Klara Valko and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-10-13 with Science categories.
Separation Methods in Drug Synthesis and Purification
Handbook Of Analytical Quality By Design
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Author : Sarwar Beg
language : en
Publisher: Academic Press
Release Date : 2021-01-09
Handbook Of Analytical Quality By Design written by Sarwar Beg and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-09 with Science categories.
Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. - Concise language for easy understanding of the novel and holistic concept - Covers key aspects of analytical development and validation - Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance
Bayesian Analysis With R For Drug Development
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2019-06-26
Bayesian Analysis With R For Drug Development written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-26 with Mathematics categories.
Drug development is an iterative process. The recent publications of regulatory guidelines further entail a lifecycle approach. Blending data from disparate sources, the Bayesian approach provides a flexible framework for drug development. Despite its advantages, the uptake of Bayesian methodologies is lagging behind in the field of pharmaceutical development. Written specifically for pharmaceutical practitioners, Bayesian Analysis with R for Drug Development: Concepts, Algorithms, and Case Studies, describes a wide range of Bayesian applications to problems throughout pre-clinical, clinical, and Chemistry, Manufacturing, and Control (CMC) development. Authored by two seasoned statisticians in the pharmaceutical industry, the book provides detailed Bayesian solutions to a broad array of pharmaceutical problems. Features Provides a single source of information on Bayesian statistics for drug development Covers a wide spectrum of pre-clinical, clinical, and CMC topics Demonstrates proper Bayesian applications using real-life examples Includes easy-to-follow R code with Bayesian Markov Chain Monte Carlo performed in both JAGS and Stan Bayesian software platforms Offers sufficient background for each problem and detailed description of solutions suitable for practitioners with limited Bayesian knowledge Harry Yang, Ph.D., is Senior Director and Head of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory experiences. He has published 6 statistical books, 15 book chapters, and over 90 peer-reviewed papers on diverse scientific and statistical subjects, including 15 joint statistical works with Dr. Novick. He is a frequent invited speaker at national and international conferences. He also developed statistical courses and conducted training at the FDA and USP as well as Peking University. Steven Novick, Ph.D., is Director of Statistical Sciences at AstraZeneca. He has extensively contributed statistical methods to the biopharmaceutical literature. Novick is a skilled Bayesian computer programmer and is frequently invited to speak at conferences, having developed and taught courses in several areas, including drug-combination analysis and Bayesian methods in clinical areas. Novick served on IPAC-RS and has chaired several national statistical conferences.
Validation Of Analytical Methods For Pharmaceutical Analysis
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Author : Oona McPolin
language : en
Publisher: Lulu.com
Release Date : 2009-05-01
Validation Of Analytical Methods For Pharmaceutical Analysis written by Oona McPolin and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-05-01 with Medical categories.
This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.