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Author :
Publisher :
ISBN 13 : 9788185386270
Total Pages : 205 pages
Book Rating : 4.3/5 (862 download)
Download or read book Basic Tests For Pharmaceutical Substances, 1/Ed. written by and published by . This book was released on 2007 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9789241545136
Total Pages : 104 pages
Book Rating : 4.5/5 (451 download)
Download or read book Basic Tests for Drugs written by World Health Organization and published by World Health Organization. This book was released on 1998 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a step-by-step guide to simple methods for verifying the identity of commonly used pharmaceutical substances and dosage forms. The basic tests described can also be used to detect mislabeled, substandard, or counterfeit products when the labeling or physical attributes give rise to doubt. Intended for use in developing countries, where resources and specialized skills may be scarce, all tests rely on a limited range of easily available reagents and equipment and need not be performed in a fully equipped laboratory or by persons with specialized training in pharmacy or chemistry. The book describes tests for 23 pharmaceutical substances and 58 pharmaceutical dosage forms, most of which are included in the WHO Model List of Essential Drugs. Basic tests for confirming the identity of four commonly used medicinal plant materials are also included. As stressed in the text, these tests, which merely confirm identity, are intended for use as primary screening tools and may need to be followed, in cases of adverse test results, by a full pharmacopoeial analysis. The book opens with a brief description of the importance of basic tests as one of the many steps needed to ensure a supply of safe and effective drugs. Chapter two describes several collections of more sophisticated tests, including volumetric or spectrophotometric analysis and thin-layer chromatography, that can be useful in the primary screening of imported pharmaceutical substances, and dosage forms. Information on how to obtain and use these guides to tests, which have not been published by WHO is also provided. Against this background, the main part of the book sets out test procedures for verifying the identity of selected pharmaceutical substances, pharmaceutical dosage forms, and medicinal plant materials. The book concludes with a cumulative index of test procedures described here and in the related WHO publications "Basic Tests for Pharmaceutical Substances" and "Basic Tests for Pharmaceutical Dosage Forms".
Author : World Health Organization
Publisher :
ISBN 13 :
Total Pages : 246 pages
Book Rating : 4.3/5 (91 download)
Download or read book Basic Tests for Pharmaceutical Substances written by World Health Organization and published by . This book was released on 1986 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9789241544184
Total Pages : 144 pages
Book Rating : 4.5/5 (441 download)
Download or read book Basic Tests for Pharmaceutical Dosage Forms written by World Health Organization and published by World Health Organization. This book was released on 1991 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241545100
Total Pages : 122 pages
Book Rating : 4.2/5 (415 download)
Download or read book Quality Control Methods for Medicinal Plant Materials written by World Health Organization and published by World Health Organization. This book was released on 1998 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: A collection of test procedures for assessing the identity, purity, and content of medicinal plant materials, including determination of pesticide residues, arsenic and heavy metals. Intended to assist national laboratories engaged in drug quality control, the manual responds to the growing use of medicinal plants, the special quality problems they pose, and the corresponding need for international guidance on reliable methods for quality control. Recommended procedures - whether involving visual inspection or the use of thin-layer chromatography for the qualitative determination of impurities - should also prove useful to the pharmaceutical industry and pharmacists working with these materials.
Author : A. C. Moffat
Publisher :
ISBN 13 :
Total Pages : 680 pages
Book Rating : 4.3/5 (91 download)
Download or read book Clarke's Analysis of Drugs and Poisons written by A. C. Moffat and published by . This book was released on 2004 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt: This manual and reference work provides a source of analytical data for drugs and related substances. It is intended for scientists faced with the difficult problem of identifying a drug in a pharmaceutical product, in a sample of tissue or body fluid, from a living patient or in post-mortem material. Volume One contains 32 chapters covering the practice of and analytical procedures used in forensic toxicology. Volume Two contains over 1750 drug and related substance monographs detailing: physical properties; analytical methods; pharmacokinetic data; and toxicity data, as well as expanded indexes and appendices. These volumes should be useful for all forensic and crime laboratories, toxicologists and analytical chemists, pathologists, poison information centres and clinical pharmacology departments.
Author : Sean C. Sweetman
Publisher :
ISBN 13 : 9780853697046
Total Pages : 3335 pages
Book Rating : 4.6/5 (97 download)
Download or read book Martindale written by Sean C. Sweetman and published by . This book was released on 2006-01-01 with total page 3335 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is thirty-fifth edition of Martindale, which provides reliable, and evaluated information on drugs and medicines used throughout the world. It contains encyclopaedic facts about drugs and medicines, with: 5,500 drug monographs; 128,000 preparations; 40,700 reference citations; 10,900 manufacturers. There are synopses of disease treatments which enables identification of medicines, the local equivalent and the manufacturer. It also Includes herbals, diagnostic agents, radiopharmaceuticals, pharmaceutical excipients, toxins, and poisons as well as drugs and medicines. Based on published information and extensively referenced
Author : Benjamin E. Blass
Publisher : Academic Press
ISBN 13 : 0128172150
Total Pages : 712 pages
Book Rating : 4.1/5 (281 download)
Download or read book Basic Principles of Drug Discovery and Development written by Benjamin E. Blass and published by Academic Press. This book was released on 2021-03-30 with total page 712 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator’s fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist’s early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry
Author : Steven W. Baertschi
Publisher : CRC Press
ISBN 13 : 9780824740214
Total Pages : 504 pages
Book Rating : 4.7/5 (42 download)
Download or read book Pharmaceutical Stress Testing written by Steven W. Baertschi and published by CRC Press. This book was released on 2005-06-24 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.
Author :
Publisher :
ISBN 13 :
Total Pages : 20 pages
Book Rating : 4.3/5 (91 download)
Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1984 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
Author : Ole Pedersen
Publisher : CRC Press
ISBN 13 : 0203492269
Total Pages : 168 pages
Book Rating : 4.2/5 (34 download)
Download or read book Pharmaceutical Chemical Analysis written by Ole Pedersen and published by CRC Press. This book was released on 2006-01-13 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Complete, referenced information in an easy-to-use formatMany of the monographs in the European Pharmacopiea, the industry standard test for certain groups of ingredients and excipients, do not describe the tests in full, but reference general methods based on test-tube chemistry. When a test fails, you need to know what went wrong, how it can be f
Author : Kim Huynh-Ba
Publisher : John Wiley & Sons
ISBN 13 : 1119120918
Total Pages : 420 pages
Book Rating : 4.1/5 (191 download)
Download or read book Analytical Testing for the Pharmaceutical GMP Laboratory written by Kim Huynh-Ba and published by John Wiley & Sons. This book was released on 2022-04-19 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.
Author : Ali S. Faqi
Publisher : Academic Press
ISBN 13 : 0128036214
Total Pages : 988 pages
Book Rating : 4.1/5 (28 download)
Download or read book A Comprehensive Guide to Toxicology in Nonclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2016-11-03 with total page 988 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology
Author : P. Heinrich Stahl
Publisher : John Wiley & Sons
ISBN 13 : 9783906390581
Total Pages : 392 pages
Book Rating : 4.3/5 (95 download)
Download or read book Handbook of Pharmaceutical Salts Properties, Selection, and Use written by P. Heinrich Stahl and published by John Wiley & Sons. This book was released on 2008-08-04 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.
Author : Stig Pedersen-Bjergaard
Publisher : John Wiley & Sons
ISBN 13 : 111936275X
Total Pages : 722 pages
Book Rating : 4.1/5 (193 download)
Download or read book Introduction to Pharmaceutical Analytical Chemistry written by Stig Pedersen-Bjergaard and published by John Wiley & Sons. This book was released on 2019-02-11 with total page 722 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive textbook on the chemical analysis of pharmaceutical drugs – fully revised and updated Introduction to Pharmaceutical Analytical Chemistry enables students to gain fundamental knowledge of the vital concepts, techniques and applications of the chemical analysis of pharmaceutical ingredients, final pharmaceutical products and drug substances in biological fluids. A unique emphasis on pharmaceutical laboratory practices, such as sample preparation and separation techniques, provides an efficient and practical educational framework for undergraduate studies in areas such as pharmaceutical sciences, analytical chemistry and forensic analysis. Suitable for foundational courses, this essential undergraduate text introduces the common analytical methods used in quantitative and qualitative chemical analysis of pharmaceuticals. This extensively revised second edition includes a new chapter on chemical analysis of biopharmaceuticals, which includes discussions on identification, purity testing and assay of peptide and protein-based formulations. Also new to this edition are improved colour illustrations and tables, a streamlined chapter structure and text revised for increased clarity and comprehension. Introduces the fundamental concepts of pharmaceutical analytical chemistry and statistics Presents a systematic investigation of pharmaceutical applications absent from other textbooks on the subject Examines various analytical techniques commonly used in pharmaceutical laboratories Provides practice problems, up-to-date practical examples and detailed illustrations Includes updated content aligned with the current European and United States Pharmacopeia regulations and guidelines Covering the analytical techniques and concepts necessary for pharmaceutical analytical chemistry, Introduction to Pharmaceutical Analytical Chemistry is ideally suited for students of chemical and pharmaceutical sciences as well as analytical chemists transitioning into the field of pharmaceutical analytical chemistry.
Author : Prasenjit Mondal
Publisher : Educreation Publishing
ISBN 13 :
Total Pages : 262 pages
Book Rating : 4./5 ( download)
Download or read book Handbook of Practical Pharmaceutical Organic, Inorganic and Medicinal Chemistry written by Prasenjit Mondal and published by Educreation Publishing. This book was released on 2019-02-20 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book described about the concept and procedure involved in various important inorganic laboratory experiments, with all the possible explanation. This book explains about the detail’s steps involved the identification of unknown chemical compounds, synthesis of numbers of drugs and intermediates with reaction mechanisms and calculation. The assay methods of various drugs and calculation of drug content also included. This book covers the entire inorganic, organic and medicinal chemistry experiments as per the Pharmacy council of India’s B. Pharm and Pharm D syllabus
Author : Christopher M. Riley
Publisher : Elsevier
ISBN 13 : 0080530354
Total Pages : 363 pages
Book Rating : 4.0/5 (85 download)
Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
