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:
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".
Download or read book Basic Tests for Pharmaceutical Dosage Forms written by and published by . This book was released on 2008 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Basic test for pharmaceutical dosage forms written by Organización Mundial de la Salud and published by . This book was released on 1991 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Dosage Forms written by Kenneth E. Avis and published by Routledge. This book was released on 2018-05-04 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.
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 2019-12-31 with total page 312 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.
Download or read book Pharmaceutical Dissolution Testing written by Jennifer J. Dressman and published by CRC Press. This book was released on 2005-07-08 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: An expertly written source on the devices, systems, and technologies used in the dissolution testing of oral pharmaceutical dosage forms, this reference provides reader-friendly chapters on currently utilized equipment, equipment qualification, consideration of the gastrointestinal physiology in test design, the analysis and interpretation of data and procedure automation -laying the foundation for the creation of appropriate and useful dissolution tests according to the anticipated location and duration of drug release from the dosage form within the gastrointestinal tract.
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:
Download or read book Tests Methods and General Requirements Quality Specifications for Pharmaceutical Substances Excippients and Dosage Forms written by and published by . This book was released on 1994 with total page 343 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sample Preparation of Pharmaceutical Dosage Forms written by Beverly Nickerson and published by Springer Science & Business Media. This book was released on 2011-08-05 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.
Download or read book How to Develop Robust Solid Oral Dosage Forms written by Bhavishya Mittal and published by Academic Press. This book was released on 2016-10-05 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. - Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more - Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin - Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues
Download or read book Physicochemical Principles of Pharmacy written by Alexander Taylor Florence and published by . This book was released on 1988 with total page 485 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the physicochemical background to the design and use of pharmaceutical dosage forms. It goes beyond the introductory aspects of the subject to show how basic physicochemical principles are essential to an understanding of every aspect of drug action, from the dosage form to the site of action in the body. This is not a textbook of physical chemistry for pharmacists, but is a book which bridges the gap between basic first-year physical chemistry and the more applied practice of later years. This extensively revised second edition includes much new material, illustrations and references to take into account recent scientific developments and curriculum changes.
Download or read book Dosage Form Design Parameters written by and published by Academic Press. This book was released on 2018-07-25 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design
Download or read book Essential Chemistry for Formulators of Semisolid and Liquid Dosages written by Vitthal S. Kulkarni and published by Academic Press. This book was released on 2015-10-15 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: A needed resource for pharmaceutical scientists and cosmetic chemists, Essential Chemistry for Formulators of Semisolid and Liquid Dosages provides insight into the basic chemistry of mixing different phases and test methods for the stability study of nonsolid formulations. The book covers foundational surface/colloid chemistry, which forms the necessary background for making emulsions, suspensions, solutions, and nano drug delivery systems, and the chemistry of mixing, which is critical for further formulation of drug delivery systems into semisolid (gels, creams, lotions, and ointments) or liquid final dosages. Expanding on these foundational principles, this useful guide explores stability testing methods, such as particle size, rheological/viscosity, microscopy, and chemical, and closes with a valuable discussion of regulatory issues. Essential Chemistry for Formulators of Semisolid and Liquid Dosages offers scientists and students the foundation and practical guidance to make and analyze semisolid and liquid formulations. - Unique coverage of the underlying chemistry that makes possible stable dosages - Quality content written by experienced experts from the drug development industry - Valuable information for academic and industrial scientists developing topical and liquid dosage formulations for pharmaceutical as well as skin care and cosmetic products
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 737 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 The International Pharmacopoeia Tests methods and general requirements quality specifications for pharmaceutical substances excipients and dosage forms written by World Health Organization and published by . This book was released on 1979 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by and published by . This book was released on 2003-01-01 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations relating to the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. It includes discussions concerning the development of the International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms as well as general quality control issues.
