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Author: 医薬品医療機器レギュラトリーサイエンス財団 Publisher: ISBN: 9784840813716 Category : Languages : en Pages : 2630
Book Description
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.
Author: 医薬品医療機器レギュラトリーサイエンス財団 Publisher: ISBN: 9784840813716 Category : Languages : en Pages : 2630
Book Description
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.
Author: The Stationery Office Publisher: Stationery Office Books (TSO) ISBN: 9780113230204 Category : Business & Economics Languages : en Pages : 0
Book Description
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.
Author: World Health Organization Publisher: World Health Organization ISBN: 924156301X Category : Medical Languages : en Pages : 1526
Book Description
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.
Author: Behnam Davani Publisher: John Wiley & Sons ISBN: 1119425018 Category : Science Languages : en Pages : 211
Book Description
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: Indian Pharmacopoeia Commission Publisher: ISBN: 9789381238073 Category : Languages : en Pages :
Book Description
The seventh edition of the Indian Pharmacopoeia (IP 2014) is published by the Indian Pharmacopoeia Commission (IPC) on behalf of the Government of India, Ministry of Health & Family Welfare. The Indian Pharmacopoeia (IP) is published in fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder. It prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines. The standards of this pharmacopoeia are authoritative and legally enforceable. It intends to help in the licensing of manufacturing, inspection and distribution of medicines. IP is published in continuing pursuit of the mission of IPC to improve the health of the people through ensuring the quality, safety and efficacy of medicines. The Commission has been receiving significant inputs from regulatory, industrial houses, academic institutions, national laboratories, individual scientists and others. Publication of IP at regular and shorter intervals is one of the main mandates of the Commission. The seventh edition of Indian Pharmacopoeia is published in accordance with the principles and designed plan decided by the Scientific Body of the IPC. To establish transparency in setting standards for this edition the contents of new monographs, revised appendices and other informations have been publicized on the website of the IPC, besides following conventional approach of obtaining comments. The feedback and inputs were reviewed by the relevant Expert Committee to ensure the feasibility and practicability of the standards and methods revised. The principle of "openness, justice and fairness" is kept in mind during compiling and editing the contents of this edition. The Indian Pharmacopoeia 2014 is presented in four volumes. The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines
Author: Raymond C. Rowe Publisher: Amer Pharmacists Assn ISBN: 9781582121352 Category : Medical Languages : en Pages : 888
Book Description
An internationally acclaimed reference work recognized as one of the most authoritative and comprehensive sources of information on excipients used in pharmaceutical formulation with this new edition providing 340 excipient monographs. Incorporates information on the uses, and chemical and physical properties of excipients systematically collated from a variety of international sources including: pharmacopeias, patents, primary and secondary literature, websites, and manufacturers' data; extensive data provided on the applications, licensing, and safety of excipients; comprehensively cross-referenced and indexed, with many additional excipients described as related substances and an international supplier's directory and detailed information on trade names and specific grades or types of excipients commercially available.
Author: 医薬品医療機器レギュラトリーサイエンス財団
Author: 医薬品医療機器レギュラトリーサイエンス財団
Author: 
Author: The Stationery Office
Author: Nihon Yakugakkai
Author: World Health Organization
Author: Behnam Davani
Author: 
Author: William Martindale
Author: Indian Pharmacopoeia Commission
Author: Raymond C. Rowe