Download or read book Japanese Pharmacopoeia written by 医薬品医療機器レギュラトリーサイエンス財団 and published by . This book was released on 2017 with total page 2630 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Japanese Pharmacopoeia 17th edition (JP XVII) English translation is fully endorsed by the society of the Japanese Pharmacopoeia. It defines the specifications, criteria and standard test methods necessary to properly ensure the quality of medicines in Japan. The Japanese language edition was effective from 1st April 2016. Key features: -General Notices, General Rules for Crude Drugs, General Rules for Preparations: revised and expanded. -Official monographs: 76 new monographs and 473 revised monographs. -General tests, processes and apparatus: 23 new standards and 10 revised standards. -Infrared reference spectra: 21 new spectra and 2 revised spectra. -Ultraviolet-visible reference spectra: 14 new spectra and 2 revised spectra This title supersedes the Japanese Pharmacopoeia 16th edition (ISBN 9784840812023), as well as JP 16th edition Supplement I (ISBN 9784840812382) and JP 16th edition Supplement II (ISBN 9784840812832). The JP aims to: 1.Include all drugs which are important from the viewpoint of health care and medical treatment. 2.Make qualitative improvement by introducing the latest science and technology. 3.Promote internationalization. Make prompt partial revision as necessary and facilitating smooth administrative operation. Ensure transparency regarding the revision, and disseminating the JP to the public.
Download or read book History of the Japanese Pharmacopoeia written by Japanese Pharmacopoeia Commission and published by . This book was released on 1987 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Japanese Pharmaceutical Excipients 2004 written by and published by Society of Japanese Pharmac. This book was released on 2004-01-01 with total page 968 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication sets out the standards which have been established for the determination of the essence, preparation method, description, quality and storage of drug substances and products, as specified in general notices, general tests, processes and apparatus, and monographs detailing a total of 479 articles including 44 newly listed, 31 articles partly revised and one article deleted. Also known as JPE 2004, this publication is a companion publication to the Japanese pharmacopoeia (2001 main ed., ISBN 4840806721) and to Japanese pharmaceutical codex.
Download or read book The Pharmacopoeia of Japan written by and published by . This book was released on 1907 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book British Pharmacopoeia written by The Stationery Office and published by Stationery Office Books (TSO). This book was released on 2016-08-15 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated annually, the British Pharmacopoeia is the only comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products. It includes almost 4,000 monographs which are legally enforced by the Human Medicines Regulations 2012.
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 The International Pharmacopoeia written by World Health Organization and published by World Health Organization. This book was released on 2006 with total page 1526 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate) adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004. It includes some additions and amendments to the general notices of the Pharmacopoeia, as well as some changes to its layout and format. Volume one contains monographs for pharmaceutical substances A to O and the General Notices; and volume two contains monographs for pharmaceutical substances P to Z, together with those for dosage forms and radiopharmaceutical preparations, the methods of analysis and reagents.
Download or read book The Japanese Pharmacopoeia written by Society of Japanese Pharmacopoeia Staff and published by . This book was released on 2000 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: This work is published under the supervision of the Research and Development, Pharmaceutical Affairs Bureau and the Ministry of Health and Welfare of Japan. This supplement contains general notices, general rules for preparations plus general tests of processes and apparatus. The book is aimed at pharmaceutical companies who require the official pharmaceutical standards in Japan.
Download or read book The Japanese Pharmacopoeia written by and published by Yakuji Nippo Limited. This book was released on 2006-01-01 with total page 1788 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the English version of the 15th edition of the Japanese Pharmacopoeia setting out the official Japanese standards for the description and quality of drug substances and products. It contains over 1,400 articles regarding: general rules for preparations; general tests, processes and apparatus; monographs on drugs; infrared reference spectra and ultraviolet-visible reference spectra.
Download or read book Supplement I to the Japanese Pharmacopoeia Sixteenth Edition written by and published by . This book was released on 2013 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Japanese Pharmacopoeia written by Pharmaceutical and medical device regulatory science society of Japan and published by . This book was released on 2012 with total page 2319 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Japanese Pharmacopoeia written by and published by . This book was released on 1996 with total page 1116 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Extra Pharmacopoeia written by William Martindale and published by . This book was released on 1958 with total page 1914 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Japanese Pharmacopoeia written by PHARMACEUTICAL AND MEDICAL DEVICE REGULATORY SCIENCE SOCIETY OF JAPAN. and published by . This book was released on 2022-07-20 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Japanese Pharmacopoeia 18h edition (JP XVIII) English translation is fully endorsed by the society of the Japanese Pharmacopoeia. It defines the specifications, criteria and standard test methods necessary to properly ensure the quality of medicines in Japan. The Japanese language edition was effective from ???
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 211 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 The Japanese Pharmacopoeia written by and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Supplement II to the Japanese Pharmacopoeia Fifteenth Edition written by and published by . This book was released on 2010 with total page 7 pages. Available in PDF, EPUB and Kindle. Book excerpt:
