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Author : United States Pharmacopeial Convention
Publisher :
ISBN 13 : 9781936424443
Total Pages : pages
Book Rating : 4.4/5 (244 download)
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:
Author : United States Pharmacopeial Convention
Publisher :
ISBN 13 : 9781889788883
Total Pages : 491 pages
Book Rating : 4.7/5 (888 download)
Download or read book USP 33 NF 28 written by United States Pharmacopeial Convention and published by . This book was released on 2010 with total page 491 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : E. Clyde Buchanan
Publisher : ASHP
ISBN 13 : 1585283312
Total Pages : 497 pages
Book Rating : 4.5/5 (852 download)
Download or read book Compounding Sterile Preparations written by E. Clyde Buchanan and published by ASHP. This book was released on 2009-02-01 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Empower your staff to improve safety, quality and compliance with the help of new guidelines and standards. We’ve updated every chapter of this popular review of the fundamentals of preparing sterile products in hospital, home-care, and community pharmacy settings to reflect the most recent revisions to USP . Included are the latest guidelines for the compounding process, quality assurance methods, and comprehensive coverage of all aspects of the dispensing process. Comprehensive documentation for the guidelines is included in the appendices.Chapters new to this edition focus on: Gap analysis and action plans Safe use of automatic compounding devices Cleaning and disinfecting Radiopharmaceuticals as CSPs Allergen extracts as CSPs.
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 : 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 : Patricia C. Kienle
Publisher :
ISBN 13 : 9781585286294
Total Pages : 0 pages
Book Rating : 4.2/5 (862 download)
Download or read book The Chapter 800 Answer Book written by Patricia C. Kienle and published by . This book was released on 2021-09-30 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Provides explanation of elements of USP Hazardous Drugs' Handling in Healthcare Settings and best practices to comply with the requirements and recommendations of the USP General Chapter"--Pref.
Author : Kerm Henriksen
Publisher :
ISBN 13 :
Total Pages : 526 pages
Book Rating : 4.7/5 (54 download)
Download or read book Advances in Patient Safety written by Kerm Henriksen and published by . This book was released on 2005 with total page 526 pages. Available in PDF, EPUB and Kindle. Book excerpt: v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309069491
Total Pages : 530 pages
Book Rating : 4.3/5 (9 download)
Download or read book Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids written by Institute of Medicine and published by National Academies Press. This book was released on 2000-08-27 with total page 530 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is the newest release in the authoritative series of quantitative estimates of nutrient intakes to be used for planning and assessing diets for healthy people. Dietary Reference Intakes (DRIs) is the newest framework for an expanded approach developed by U.S. and Canadian scientists. This book discusses in detail the role of vitamin C, vitamin E, selenium, and the carotenoids in human physiology and health. For each nutrient the committee presents what is known about how it functions in the human body, which factors may affect how it works, and how the nutrient may be related to chronic disease. Dietary Reference Intakes provides reference intakes, such as Recommended Dietary Allowances (RDAs), for use in planning nutritionally adequate diets for different groups based on age and gender, along with a new reference intake, the Tolerable Upper Intake Level (UL), designed to assist an individual in knowing how much is "too much" of a nutrient.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 030967218X
Total Pages : 353 pages
Book Rating : 4.3/5 (96 download)
Download or read book Compounded Topical Pain Creams written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-07-21 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.
Author : United States. Food and Drug Administration. Division of Microbiology
Publisher :
ISBN 13 :
Total Pages : 180 pages
Book Rating : 4.F/5 ( download)
Download or read book Bacteriological Analytical Manual written by United States. Food and Drug Administration. Division of Microbiology and published by . This book was released on 1969 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Behnam Davani
Publisher : John Wiley & Sons
ISBN 13 : 1119425034
Total Pages : 258 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 2017-07-12 with total page 258 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 :
Publisher :
ISBN 13 :
Total Pages : 676 pages
Book Rating : 4.3/5 (91 download)
Download or read book Pharmacopoeia of the United States of America written by and published by . This book was released on 1893 with total page 676 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
ISBN 13 : 1441908897
Total Pages : 261 pages
Book Rating : 4.4/5 (419 download)
Download or read book Pharmaceutical Stability Testing to Support Global Markets written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2009-12-04 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.
Download or read book The United States Pharmacopeia; USP 34 written by and published by . This book was released on 2011 with total page 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 : 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.
