Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Download Handbook Of Dissolution Testing full books in PDF, epub, and Kindle. Read online Handbook Of Dissolution Testing ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Author : William A. Hanson
Publisher :
ISBN 13 :
Total Pages : 180 pages
Book Rating : 4.3/5 (91 download)
Download or read book Handbook of Dissolution Testing written by William A. Hanson and published by . This book was released on 1982 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Royal Hanson
Publisher :
ISBN 13 : 9780976151906
Total Pages : 199 pages
Book Rating : 4.1/5 (519 download)
Download or read book Handbook of Dissolution Testing written by Royal Hanson and published by . This book was released on 2004 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 0849383595
Total Pages : 602 pages
Book Rating : 4.8/5 (493 download)
Download or read book Handbook of Bioequivalence Testing written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2007-08-22 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made
Author : Umesh V. Banakar
Publisher : John Wiley & Sons
ISBN 13 : 1119634601
Total Pages : 564 pages
Book Rating : 4.1/5 (196 download)
Download or read book Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence written by Umesh V. Banakar and published by John Wiley & Sons. This book was released on 2022-01-19 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore the cutting-edge of dissolution testing in an authoritative, one-stop resource In Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence: Science, Applications, and Beyond, distinguished pharmaceutical advisor and consultant Dr. Umesh Banakar delivers a comprehensive and up-to-date reference covering the established and emerging roles of dissolution testing in pharmaceutical drug development. After discussing the fundamentals of the subject, the included resources go on to explore common testing practices and methods, along with their associated challenges and issues, in the drug development life cycle. Over 19 chapters and 1100 references allow practicing scientists to fully understand the role of dissolution, apart from mere quality control. Readers will discover a wide range of topics, including automation, generic and biosimilar drug development, patents, and clinical safety. This volume offers a one-stop resource for information otherwise scattered amongst several different regulatory regimes. It also includes: A thorough introduction to the fundamentals and essential applications of pharmaceutical dissolution testing Comprehensive explorations of the foundations and drug development applications of bioavailability and bioequivalence Practical discussions about solubility, dissolution, permeability, and classification systems in drug development In-depth examinations of the mechanics of dissolution, including mathematical models and simulations An elaborate assessment of biophysiologically relevant dissolution testing and IVIVCs, and their unique applications A complete understanding of the methods, requirements, and global regulatory expectations pertaining to dissolution testing of generic drug products Ideal for drug product development and formulation scientists, quality control and assurance professionals, and regulators, Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence is also the perfect resource for intellectual property assessors.
Author : Satinder Ahuja
Publisher : Elsevier
ISBN 13 : 0080455182
Total Pages : 679 pages
Book Rating : 4.0/5 (84 download)
Download or read book Handbook of Pharmaceutical Analysis by HPLC written by Satinder Ahuja and published by Elsevier. This book was released on 2005-02-09 with total page 679 pages. Available in PDF, EPUB and Kindle. Book excerpt: High pressure liquid chromatography–frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry. Written by selected experts in their respective fields, the Handbook of Pharmaceutical Analysis by HPLC Volume 6, provides a complete yet concise reference guide for utilizing the versatility of HPLC in drug development and quality control. Highlighting novel approaches in HPLC and the latest developments in hyphenated techniques, the book captures the essence of major pharmaceutical applications (assays, stability testing, impurity testing, dissolution testing, cleaning validation, high-throughput screening). A complete reference guide to HPLC Describes best practices in HPLC and offers 'tricks of the trade' in HPLC operation and method development Reviews key HPLC pharmaceutical applications and highlights currents trends in HPLC ancillary techniques, sample preparations, and data handling
Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
ISBN 13 : 0387856277
Total Pages : 389 pages
Book Rating : 4.3/5 (878 download)
Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Rajesh Krishna
Publisher : Springer Science & Business Media
ISBN 13 : 038772379X
Total Pages : 416 pages
Book Rating : 4.3/5 (877 download)
Download or read book Biopharmaceutics Applications in Drug Development written by Rajesh Krishna and published by Springer Science & Business Media. This book was released on 2007-09-20 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 135158233X
Total Pages : 442 pages
Book Rating : 4.3/5 (515 download)
Download or read book Handbook of Preformulation written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2019-03-22 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 new drug development. Entirely focused on preformulation principles, this fully revised and updated Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity. Features: Addresses the preformulation studies of three different types of new active entities - chemical, biological, and botanical, which is the latest established class of active ingredient classified by the FDA Illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects Includes extensive flow charts for characterization decision making Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization Includes over 50% new material
Author : Nikoletta Fotaki
Publisher : John Wiley & Sons
ISBN 13 : 1118675835
Total Pages : 314 pages
Book Rating : 4.1/5 (186 download)
Download or read book In Vitro Drug Release Testing of Special Dosage Forms written by Nikoletta Fotaki and published by John Wiley & Sons. This book was released on 2019-10-11 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.
Author : Safaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420081314
Total Pages : 458 pages
Book Rating : 4.4/5 (2 download)
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Safaraz K. Niazi and published by CRC Press. This book was released on 2016-04-19 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1482226383
Total Pages : 1007 pages
Book Rating : 4.4/5 (822 download)
Download or read book Handbook of Bioequivalence Testing written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2014-10-29 with total page 1007 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m
Author : Hong Wen
Publisher : John Wiley & Sons
ISBN 13 : 1118060326
Total Pages : 571 pages
Book Rating : 4.1/5 (18 download)
Download or read book Oral Controlled Release Formulation Design and Drug Delivery written by Hong Wen and published by John Wiley & Sons. This book was released on 2011-01-14 with total page 571 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420048457
Total Pages : 258 pages
Book Rating : 4.4/5 (2 download)
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2004-04-27 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul
Author : Sandy Weinberg
Publisher : John Wiley & Sons
ISBN 13 : 0470371382
Total Pages : 390 pages
Book Rating : 4.4/5 (73 download)
Download or read book Guidebook for Drug Regulatory Submissions written by Sandy Weinberg and published by John Wiley & Sons. This book was released on 2009-03-11 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: Destined to become every regulatory director's essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.
Author : American Bar Association. House of Delegates
Publisher : American Bar Association
ISBN 13 : 9781590318737
Total Pages : 216 pages
Book Rating : 4.3/5 (187 download)
Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Author : Andrew Davis
Publisher : Royal Society of Chemistry
ISBN 13 : 1782621830
Total Pages : 753 pages
Book Rating : 4.7/5 (826 download)
Download or read book The Handbook of Medicinal Chemistry written by Andrew Davis and published by Royal Society of Chemistry. This book was released on 2015-07-07 with total page 753 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug discovery is a constantly developing and expanding area of research. Developed to provide a comprehensive guide, the Handbook of Medicinal Chemistry covers the past, present and future of the entire drug development process. Highlighting the recent successes and failures in drug discovery, the book helps readers to understand the factors governing modern drug discovery from the initial concept through to a marketed medicine. With chapters covering a wide range of topics from drug discovery processes and optimization, development of synthetic routes, pharmaceutical properties and computational biology, the handbook aims to enable medicinal chemists to apply their academic understanding to every aspect of drug discovery. Each chapter includes expert advice to not only provide a rigorous understanding of the principles being discussed, but to provide useful hints and tips gained from within the pharmaceutical industry. This expertise, combined with project case studies, highlighting and discussing all areas of successful projects, make this an essential handbook for all those involved in pharmaceutical development.
Author : Charles M. Hansen
Publisher : CRC Press
ISBN 13 : 1420006835
Total Pages : 546 pages
Book Rating : 4.4/5 (2 download)
Download or read book Hansen Solubility Parameters written by Charles M. Hansen and published by CRC Press. This book was released on 2007-06-15 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hansen solubility parameters (HSPs) are used to predict molecular affinities, solubility, and solubility-related phenomena. Revised and updated throughout, Hansen Solubility Parameters: A User's Handbook, Second Edition features the three Hansen solubility parameters for over 1200 chemicals and correlations for over 400 materials including p
