Download or read book Usp39 Nf34 written by United States Pharmacopeial Convention and published by . This book was released on 2015-11-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

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Download or read book USP39 NF34 Spanish written by United States Pharmacopeial Convention and published by . This book was released on 2016-03-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Pharmaceutical Analysis for Small Molecules written by Behnam Davani and published by John Wiley & Sons. This book was released on 2017-08-14 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.

Download or read book Statistical Applications for Chemistry Manufacturing and Controls CMC in the Pharmaceutical Industry written by Richard K. Burdick and published by Springer. This book was released on 2017-02-14 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.

Download or read book Encyclopedia of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 4057 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

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 2022-03-31 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.

Download or read book Pharmaceutical Formulation written by Geoffrey D Tovey and published by Royal Society of Chemistry. This book was released on 2018-06-25 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.

Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-09-29 with total page 624 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)

Download or read book Handbook of Pharmaceutical Wet Granulation written by Ajit S. Narang and published by Academic Press. This book was released on 2018-08-31 with total page 890 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Download or read book Wilderness EMS written by Seth C. Hawkins and published by Lippincott Williams & Wilkins. This book was released on 2017-10-16 with total page 1277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Wilderness EMS is designed for EMS providers and leaders who deliver medical care in the wilderness, and those practicing wilderness medicine as part of a formal team. The textbook is a comprehensive, expertly-written reference ideal for this fast-changing and multidisciplinary specialty. This first-of-its-kind text provides specialized instruction and best practices for wilderness EMS practitioners and students – crucial information for the success of today’s rescue missions. A strong foundation in evidence-based medicine, clinical experience, and field applicability makes it especially useful for any EMS provider in a wilderness environment.

Download or read book Protein Therapeutics written by Tristan Vaughan and published by John Wiley & Sons. This book was released on 2017-07-28 with total page 754 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

Download or read book Food Analysis written by S. Suzanne Nielsen and published by Springer. This book was released on 2017-06-06 with total page 648 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fifth edition provides information on techniques needed to analyze foods for chemical and physical properties. The book is ideal for undergraduate courses in food analysis and is also an invaluable reference to professionals in the food industry. General information chapters on regulations, labeling, sampling, and data handling provide background information for chapters on specific methods to determine chemical composition and characteristics, physical properties, and objectionable matter and constituents. Methods of analysis covered include information on the basic principles, advantages, limitations, and applications. Sections on spectroscopy and chromatography along with chapters on techniques such as immunoassays, thermal analysis, and microscopy from the perspective of their use in food analysis have been expanded. Instructors who adopt the textbook can contact the editor for access to a website with related teaching materials.

Download or read book PHARMACEUTICS written by Mr. Souvik Giri and published by JEC PUBLICATION. This book was released on 2023-05-03 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is a great honor to present the book Pharmaceutics - I to the D. Pharm 1st Year pharmacy students. This book has been written strictly in accordance with the current Pharmacy Council of India syllabus for D. Pharm students. Keeping in mind the needs of students and teachers, this book has been written to cover all topics in an easy-to-compress manner within the prescribed syllabus limits and it provides the students with fundamentals. All efforts have been made to make sure that text is error-free and that the subject is introduced in a student-friendly and understanding way. However, suggestions or constructive comments would be greatly appreciated and suggestions or constructive comments would be greatly appreciated and would be included in a future edition. For suggestion or comments: [email protected]

Download or read book Essentials of Pain Medicine E Book written by Honorio Benzon and published by Elsevier Health Sciences. This book was released on 2017-10-01 with total page 688 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accessible, concise, and clinically focused, Essentials of Pain Medicine, 4th Edition, by Drs. Honorio T. Benzon, Srinivasa N. Raja, Scott M. Fishman, Spencer S. Liu, and Steven P. Cohen, presents a complete, full-color overview of today’s theory and practice of pain medicine and regional anesthesia. It provides practical guidance on the full range of today’s pharmacologic, interventional, neuromodulative, physiotherapeutic, and psychological management options for the evaluation, treatment, and rehabilitation of persons in pain. Covers all you need to know to stay up to date in practice and excel at examinations – everything from basic considerations through local anesthetics, nerve block techniques, acupuncture, cancer pain, and much more. Uses a practical, quick-reference format with short, easy-to-read chapters. Presents the management of pain for every setting where it is practiced, including the emergency room, the critical care unit, and the pain clinic. Features hundreds of diagrams, illustrations, summary charts and tables that clarify key information and injection techniques – now in full color for the first time. Includes the latest best management techniques, including joint injections, ultrasound-guided therapies, and new pharmacologic agents (such as topical analgesics). Discusses recent global developments regarding opioid induced hyperalgesia, addiction and substance abuse, neuromodulation and pain management, and identification of specific targets for molecular pain.

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

Download or read book Biotechnology Operations written by John M. Centanni and published by CRC Press. This book was released on 2016-09-19 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.