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Author : United States Pharmacopeial Convention
Publisher :
ISBN 13 : 9781936424320
Total Pages : pages
Book Rating : 4.4/5 (243 download)
Download or read book Usp38-Nf33 written by United States Pharmacopeial Convention and published by . This book was released on 2014-11-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Lanju Zhang
Publisher : Springer
ISBN 13 : 3319235583
Total Pages : 698 pages
Book Rating : 4.3/5 (192 download)
Download or read book Nonclinical Statistics for Pharmaceutical and Biotechnology Industries written by Lanju Zhang and published by Springer. This book was released on 2016-01-13 with total page 698 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.
Author : Graham P. Bunn
Publisher : CRC Press
ISBN 13 : 1351646990
Total Pages : 369 pages
Book Rating : 4.3/5 (516 download)
Download or read book Good Manufacturing Practices for Pharmaceuticals, Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Author :
Publisher : Academic Press
ISBN 13 : 0128051760
Total Pages : 454 pages
Book Rating : 4.1/5 (28 download)
Download or read book Profiles of Drug Substances, Excipients and Related Methodology written by and published by Academic Press. This book was released on 2016-02-26 with total page 454 pages. Available in PDF, EPUB and Kindle. Book excerpt: Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. Contributions from leading authorities Informs and updates on all the latest developments in the field
Author : Suzanne M. Kresta
Publisher : John Wiley & Sons
ISBN 13 : 1118944291
Total Pages : 1040 pages
Book Rating : 4.1/5 (189 download)
Download or read book Advances in Industrial Mixing written by Suzanne M. Kresta and published by John Wiley & Sons. This book was released on 2016-03-11 with total page 1040 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in Industrial Mixing is a companion volume and update to the Handbook of Industrial Mixing. The second volume fills in gaps for a number of industries that were not covered in the first edition. Significant changes in five of the fundamental areas are covered in entirely updated or new chapters. The original text is provided as a searchable pdf file on the accompanying USB. This book explains industrial mixers and mixing problems clearly and concisely. Gives practical insights by the top professionals in the field, combining industrial design standards with fundamental insight. Details applications in 14 key industries. Six of these are new since the first edition. Provides the professional with information he/she did not receive in school. Five completely rewritten chapters on mixing fundamentals where significant advances have happened since the first edition and seven concise update chapters which summarize critical technical information.
Author : Larry L. Augsburger
Publisher : CRC Press
ISBN 13 : 1841849774
Total Pages : 436 pages
Book Rating : 4.8/5 (418 download)
Download or read book Pharmaceutical Dosage Forms written by Larry L. Augsburger and published by CRC Press. This book was released on 2017-10-30 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.
Author : Atta-ur-Rahman
Publisher : Bentham Science Publishers
ISBN 13 : 1681081431
Total Pages : 304 pages
Book Rating : 4.6/5 (81 download)
Download or read book Applications in Food Sciences written by Atta-ur-Rahman and published by Bentham Science Publishers. This book was released on 2016-04-12 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Applications of NMR Spectroscopy is a book series devoted to publishing the latest advances in the applications of nuclear magnetic resonance (NMR) spectroscopy in various fields of organic chemistry, biochemistry, health and agriculture. The fourth volume of the series features several reviews focusing on NMR spectroscopic techniques in food sciences. Readers will find references on methods used to test food quality, food color analysis, the role of Tannins in wine taste as well as NMR studies on lipid oxidation and large protein complexes.
Author : Colin Poole
Publisher : Elsevier
ISBN 13 : 0323983014
Total Pages : 692 pages
Book Rating : 4.3/5 (239 download)
Download or read book Instrumental Thin-Layer Chromatography written by Colin Poole and published by Elsevier. This book was released on 2023-01-14 with total page 692 pages. Available in PDF, EPUB and Kindle. Book excerpt: Instrumental Thin-Layer Chromatography, Second Edition offers a comprehensive source of authoritative information on all aspects of instrumental thin-layer chromatography. The use of short, topic-focused chapters facilitates identifying information of immediate interest for familiar or emerging uses of thin-layer chromatography. The book gives those working in both academia and industry the opportunity to learn, refresh, or deepen their understanding of fundamental and instrumental aspects of thin-layer chromatography, as well as the tools to interpret and manage chromatographic data. The book serves as a practical consolidated guide to the selection of separation conditions and the use of auxiliary techniques. This fully updated new edition restores the contemporary character of the book for those involved in advancing the technology, analyzing data produced, or applying the technique to new application areas. Some chapters have been consolidated to make room for topics not covered in the first edition, reflecting general changes in the field of thin-layer chromatography, especially in effects-directed detection, convenient interfaces for advanced spectroscopic detection, and greater automation possibilities. This book is a valuable reference for anyone who needs to acquire fundamental and practical information to facilitate progress in research and management functions utilizing information acquired by thin-layer chromatography. Features individual chapters written by recognized authoritative and visionary experts in the field Provides an overview and focused treatment of a single topic Provides tables and diagrams with commonly used data to facilitate practical work, comparison of results, and decision-making Places modern developments in the research literature into a general context not always apparent to inexperienced users of the technique Offers comprehensive updates to all chapters Includes new chapters on instrument platforms, effects-directed detection, data analysis tools, small-scale and microfluidic planar separation systems, and applications to the separation of amino acids and peptides, the analysis of saccharides and lipids, and forensic analysis
Author : Hideyuki Ito
Publisher : MDPI
ISBN 13 : 3038978345
Total Pages : 318 pages
Book Rating : 4.0/5 (389 download)
Download or read book Special Issue Dedicated to Late Professor Takuo Okuda written by Hideyuki Ito and published by MDPI. This book was released on 2019-04-30 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antioxidative polyphenols represented by tannins and flavonoids are rich in numerous food sources and traditional natural medicines and currently attracting increased attention in health care and food industries because of their multiple biological activities that are favorable to human health. Commemorating the outstanding achievements on tannins by Dr. Takuo Okuda on the occasion of his passing away in December 2016, his colleagues, friends, and worldwide experts of polyphenol research have contributed 18 papers on their recent study to the Special Issue of Molecules. This book is its reprinted form. This covers reviews of structural features, historical usages, and biological activities of unique class of ellagitannins and condensed tannins, and original articles on the most up-to-date findings on the anticancer effect of green tea catechins, the antivirus effect of tannins comparing with the clinically used drugs, the analytical method of ellagitannins using quantitative NMR, the chemical structures of Hydrangea-blue complex (pigment) and condensed tannins in Ephedra sinica and purple prairie clover, and the relationship of condensed tannins in legumes and grape-marc with methane production in the in vitro ruminant system, and others. This book will be useful to natural product chemists and also to researchers in pharmaceutical and/or food industry.
Author : Nevin Tasaltin
Publisher : BoD – Books on Demand
ISBN 13 : 1839624795
Total Pages : 327 pages
Book Rating : 4.8/5 (396 download)
Download or read book Advanced Functional Materials written by Nevin Tasaltin and published by BoD – Books on Demand. This book was released on 2020-11-26 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book was written by authors in the field of preparation of advanced functional materials and their wide-ranging applications. The topics in the book include: preparation of several advanced functional materials, and their applications in sensors, health, concrete, textile, glasses, and pharmacy. In this book, the authors focused on recent studies, applications, and new technological developments in fundamental properties of advanced functional materials.
Author : Michael Gruss
Publisher : John Wiley & Sons
ISBN 13 : 3527823069
Total Pages : 576 pages
Book Rating : 4.5/5 (278 download)
Download or read book Solid State Development and Processing of Pharmaceutical Molecules written by Michael Gruss and published by John Wiley & Sons. This book was released on 2021-09-14 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Solid State Development and Processing of Pharmaceutical Molecules A guide to the lastest industry principles for optimizing the production of solid state active pharmaceutical ingredients Solid State Development and Processing of Pharmaceutical Molecules is an authoritative guide that covers the entire pharmaceutical value chain. The authors—noted experts on the topic—examine the importance of the solid state form of chemical and biological drugs and review the development, production, quality control, formulation, and stability of medicines. The book explores the most recent trends in the digitization and automation of the pharmaceutical production processes that reflect the need for consistent high quality. It also includes information on relevant regulatory and intellectual property considerations. This resource is aimed at professionals in the pharmaceutical industry and offers an in-depth examination of the commercially relevant issues facing developers, producers and distributors of drug substances. This important book: Provides a guide for the effective development of solid drug forms Compares different characterization methods for solid state APIs Offers a resource for understanding efficient production methods for solid state forms of chemical and biological drugs Includes information on automation, process control, and machine learning as an integral part of the development and production workflows Covers in detail the regulatory and quality control aspects of drug development Written for medicinal chemists, pharmaceutical industry professionals, pharma engineers, solid state chemists, chemical engineers, Solid State Development and Processing of Pharmaceutical Molecules reviews information on the solid state of active pharmaceutical ingredients for their efficient development and production.
Author : Yihong Qiu
Publisher : Academic Press
ISBN 13 : 0128026375
Total Pages : 1178 pages
Book Rating : 4.1/5 (28 download)
Download or read book Developing Solid Oral Dosage Forms written by Yihong Qiu and published by Academic Press. This book was released on 2016-11-08 with total page 1178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more. Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives
Author : Martin J. Forrest
Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110640287
Total Pages : 358 pages
Book Rating : 4.1/5 (16 download)
Download or read book Rubber Analysis written by Martin J. Forrest and published by Walter de Gruyter GmbH & Co KG. This book was released on 2019-04-01 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rubber analysis plays a vital part in ensuring that manufactured products are fit for purpose. This comprehensive, application-based book with up-to-date referencing covers all important applications and subject area associated with the analysis of rubber compounds and rubber products. Includes characterization of rubber polymers, rubber fumes, identification of extractables and leachables, as well as reverse engineering on compounded products.
Author : Li Song
Publisher : World Scientific
ISBN 13 : 9813147768
Total Pages : 568 pages
Book Rating : 4.8/5 (131 download)
Download or read book Engineering Stem Cells For Tissue Regeneration written by Li Song and published by World Scientific. This book was released on 2017-11-24 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: Tissue engineering integrates knowledge and tools from biological sciences and engineering for tissue regeneration. A challenge for tissue engineering is to identify appropriate cell sources. The recent advancement of stem cell biology provides enormous opportunities to engineer stem cells for tissue engineering. The impact of stem cell technology on tissue engineering will be revolutionary. This book covers state-of-the-art knowledge on the potential of stem cells for the regeneration of a wide range of tissues and organs, including cardiovascular, musculoskeletal, neurological and skin tissues. The technology platforms for studying and engineering stem cells, such as hydrogel and biomaterials development, microfluidics system and microscale patterning, are also illustrated. Regulatory challenges and quality control for clinical translation are also detailed. This book provides an comprehensive update on the advancement in the field of stem cells and regenerative medicine, and serves as a valuable resource for both researchers and students. Contents: Tissue Engineering: From Basic Biology to Cell-Based Applications (R M Nerem)Recent Advances and Future Perspectives on Somatic Cell Reprogramming (K-Y Kim & I-H Park)Hematopoietic Stem Cells (J J Trowbridge)Mesenchymal Stem Cells for Tissue Regeneration (N F Huang & S Li)Delivery Vehicles for Deploying Mesenchymal Stem Cells in Tissue Repair (M S Friedman & J K Leach)Stem Cells for Cardiac Tissue Engineering (J L Young et al.)Cardiovascular System: Stem Cells in Tissue-Engineered Blood Vessels (R Sawh-Martinez et al.)Stem Cells for Vascular Regeneration: An Engineering Approach (L E Dickinson & S Gerecht)Stem Cells and Wound Repair (S H Ko et al.)Engineering Cartilage: From Materials to Small Molecules (J M Coburn & J H Elisseeff)Adult Stem Cells for Articular Cartilage Tissue Engineering (S Saha et al.)Stem Cells for Disc Repair (A A Allon et al.)Skeletal Tissue Engineering: Progress and Prospects (N J Panetta et al.)Clinical Applications of a Stem Cell Based Therapy for Oral Bone Reconstruction (B McAllister & K Haghighat)Therapeutic Strategies for Repairing the Injured Spinal Cord Using Stem Cells (M S Beattie & J C Bresnahan)Potential of Tissue Engineering and Neural Stem Cells in the Understanding and Treatment of Neurodegenerative Diseases (C Auclair-Daigle & F Berthod)High-Throughput Systems for Stem Cell Engineering (D A Brafman et al.)Microscale Technologies for Tissue Engineering and Stem Cell Differentiation (J W Nichol et al.)Quality Control of Autologous Cell- and Tissue-Based Therapies (N Dusserre et al.)Regulatory Challenges for Cell-Based Therapeutics (T McAllister et al.) Readership: Life science scientists; biomedical researchers; cell biologists; academics, postgraduate students and advanced undergraduate students in cell biology, biochemistry and genetics; surgeons; clinicians; biotechnology and pharmaceutical industry professionals. Keywords: Stem Cells;Tissue Engineering;Regenerative Medicine;Biotechnology;Cell EngineeringReview:0
Author : Behnam Davani
Publisher : John Wiley & Sons
ISBN 13 : 1119425018
Total Pages : 256 pages
Book Rating : 4.1/5 (194 download)
Download or read book Pharmaceutical Analysis for Small Molecules written by Behnam Davani and published by John Wiley & Sons. This book was released on 2017-08-01 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Robert Thomas
Publisher : CRC Press
ISBN 13 : 1351984403
Total Pages : 474 pages
Book Rating : 4.3/5 (519 download)
Download or read book Measuring Elemental Impurities in Pharmaceuticals written by Robert Thomas and published by CRC Press. This book was released on 2018-01-29 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters , , and , together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials. It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes: The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials. Covers heavy metals testing in the pharmaceutical industry from an historical perspective. Gives an overview of current USP Chapters and and ICH Q3D Step 4 Guidelines. Explains the purpose of validation protocols used in Chapter , including how J-values are calculated Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES. Offers guidelines about the optimum strategy for risk assessment Provides tips on how best to prepare and present your data for regulatory inspection. An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand.
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.
