YAKUJI NIPPO’s English Publications
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New Titles
Supplement II to the Japanese Pharmacopoeia Fifteenth Edition (Supplement II to JP XV)
JPY26,000; 2010; p.p 312; A4 Format (210 x 297 mm); Paperback; ISBN978-4-8408-1135-4 C3047; Published by Pharmaceutical and Medical Device Regulatory Science Society of Japan
Official Monographs provides approx. 230 articles, including 106 articles newly added, 1 article deleted, 160 articles revised. General Tests, Process and Apparatus provides the following tests newly added: 2.04 Amino Acid Analysis of Proteins. Revision is made on the following 9 tests: 1.07 Heavy Metals Limit Test, 1.08 Nitrogen Determination (Semimicro-Kjeldahl Method), 1.09 Qualitative Tests, 2.01 Liquid Chromatography, 3.01 Determination of Bulk and Tapped Densities, 3.02 Specific Surface Area by Gas Adsorption, 3.03 Powder Particle Density Determination, 3.04 Particle Size Determination, 7.02 Test Methods for Plastic Containers. Addenda include the followings: The monographs revised in the Supplement II to JP 15th Edition and their revised sections, PMRJ Reference Standards Ordering Information for Foreign Users, PMRJ Reference Standards Catalog, PMRJ Order Form, and PMRJ Reference Standards User Information.
Pharmaceuticals
The Japanese Pharmacopoeia Fifteenth Edition (JP XV)
JPY60,000; 2007; pp. 1820; A4 format (210 x 297 mm); hardbound; ISBN978-4-8408-0974-0 C3047; Published by Published by the Society of Japanese Pharmacopoeia (Pharmaceutical and Medical Device Regulatory Science Society of Japan); Official from March 31, 2006; Official Monographs provides 1483 articles, including 102 articles newly added and 8 articles deleted. Comprises the following items in order: The Ministry of Health, Labour and Welfare Ministerial Notification; Contents; Preface; General Notices; General Rules for Crude Drugs; General Rules for Preparations; General Tests, Processes and Apparatus; Official Monographs, including Monographs for Crude Drugs; Infrared Reference Spectra; Ultraviolet-visual Reference Spectra; General Information; Atomic Weight Table (2004) and Standard Atomic Weights 2004 as Appendix ; and Cumulative Index (English, Latin and Japanese titles).
Supplement I to the Japanese Pharmacopoeia Fifteenth Edition (Supplement I to JP XV)
JPY20,000; 2008; p.p 264; A4 Format (210 x 297 mm); Paperback; ISBN978-4-8408-1042-5 C3047; Published by the Society of Japanese Pharmacopoeia (Pharmaceutical and Medical Device Regulatory Science Society of Japan)
Official Monographs provides approx. 260 articles, including 6 articles deleted, 90 articles newly added, and the remaining articles revised. General Tests, Processes and Apparatus provides the following test newly added: 6.11 Foreign Insoluble Matter Test for Ophthalmic Solutions. Revision is made on the following 10 tests: 1.09 Qualitative Tests, 2.01 Liquid Chromatography, 2.02 Gas Chromatography, 2.48 Water Determination (Karl Fisher Method), 2.49 Optical Rotation Determination, 4.01 Bacterial Endotoxins Test, 4.05 Microbial Limit Test, 6.01 Test for Metal Particles in Ophthalmic Ointments, 6.08 Insoluble Particulate Matter Test for Ophthalmic Solutions, 6.10 Dissolution Test.
The Japanese Pharmacopoeial Forum (JPF) (Bilingual in Japanese/English)
US$260.00 for serial publications (quarterly); A4 format (210 x 297 mm); paperback; Published by Pharmaceutical and Medical Device Regulatory Science Society of Japan (the Society of Japanese Pharmacopoeia); Provides firsthand information and ideas relating to the development of drug standards and analytical methods, and public notices and actions taken by the government’s JP committee.
Japanese Accepted Names for Pharmaceuticals 1996 (JAN 1996) (Bilingual in Japanese/English)
JPY29,126; 1996; pp.742; B5 format (181 x 257 mm); paperback; ISBN4-8408-0394-3 C3047; Edited by the Society of Japanese Pharmacopoeia (Pharmaceutical and Medical Device Regulatory Science Society of Japan); Carries 2100 articles, mainly comprising in order Introduction; Japanese Accepted Names (JAN) for Pharmaceutical Substances; Indexes such as general, therapeutic category, CAS registry number, and molecular formula; and List of Manufacturers.
Japanese Pharmaceutical Excipients 2004 (JPE 2004)
JPY19,000; 2004; pp. 980; A5 format (148 x 210 mm); hardback; ISBN4-8408-0806-6 C3047; Carries 479 articles, which include 44 articles newly listed, 31 articles partly revised and 1 article deleted.
Japanese Pharmaceutical Excipients Directory 1996 (JPED 1996)
JPY27,185; 1996; pp.640; B5 Format (181 x 257 mm); hardback; ISBN4-8408-0418-4 C3047; Provides Preface; Monographs for 590 articles as official JPE; Appendix to carry 522 articles as non-official JPE; and Manufacturers’ Directory, followed by Index.
The Japanese GMP Regulations 2003
JPY7,000; 2003; pp. 190; A4 format (210 x 297 mm); Paperbound; ISBN4-8408-0761-2 C3047
Japan’s and ICH Guidelines for New Drug Registration 1999
JPY13,000; 1999; pp. 780; A4 format (210 x 297mm); paperback; ISBN4-8408-0569-5 C3047; Provides Japan’s latest regulations required for new drug approval applications and the related MHW notification, PAL, ordinance, etc., including 17 Japan’s guidelines with enforcement of GLP ordinance, handling of nonclinical safety data, procedure to conduct GLP on-site review, GLP compliance review guideline, toxicity studies of drugs, general pharmacology studies, nonclinicval pharmacokinetic studies, etc.; 36 ICH guidelines many of which have been implemented (Step 5) in Japan by being adopted with MHW notification published.
SUPPLEMENT 2000: Japan’s and ICH Guidelines for New Drug Registration
JPY7,000; 2000; pp. 300; A4 format (210 x 297mm); paperback; ISBN4-8408-0611-X C3047; Provides the latest notifications issued by MHW on new drug application, and requirements for drug approval; the combined two guidelines of Japan’s and ICH guidelines for “Genotoxicity Studies of Drugs” and “Carcinogenicity Studies of Drugs,” and ICH Guidelines for Q6A, S7, E11, E12 & M4.
ICH E5 Handbook 1999 with Q &A on the “Guideline for Ethnic Factors in the Acceptability of Foreign Clinical Data”
JPY3,700; 1999; pp. 74; Irregular format (182 x 21 mm); paperback: ISBN4-8408-0526-1 C3047; Editorial Supervision by MHW; Explains handling of clinical data on pharmaceuticals generated in the foreign countries through the Questions and Answers on the ICH guideline E5.
Japan’s New GCP and Other Rules on Clinical Trials PART 2
JPY10,000; 1998; pp.270; A4 format (210 x 297 mm); paperback; ISBN4-8408-0479-6 C3047; Editorial Supervision by MHW; Explains how to apply the new GCP guideline to clinical trials, in addition to GMP for investigational products.
Japan’s New GCP and Other Rules on Clinical Trials PART 3 with CD-ROM Containing the Laws, Ordinances & Notification Collected in the PARTS 1 to 3 (See Section Drug on the Parts 1 & 2)
JPY22,000; 1999; pp. 160; A4 format (210 x 297 mm); paperback; ISBN4-8408-0515-6 C3047; Editorial Supervision by MHW; Provides Japan’s new GCP regulations and their impact on clinical trials, Japan’s medical insurance application of Special Medical Care Expense provision, research grants and clarification of investigators’ trial-related work, and Appendixes: Insurance medical care institutions and insured medical care, preparation of medical care fee bills, medical care fee points table, handling and conduct of contract researches, clinical trial handling at National University Hospitals, guidelines on clinical trials conducted at private medical school hospitals, etc.
Japanese Standards for Herbal Medicines (JSHM)
JPY17,476; 1993; pp.361; A5 format (148 x 210 mm); hardback; ISBN4-8408-0299-8 C3047; Carries 248 articles, comprising General Notices; Monographs; and Appendix to include crude drugs test, general rules for crude drugs, allied plants and animals species, and photographs and microscopic views), followed by Index.
Summary Basis of Approval (SBA)
Editorial Supervision by MHW; Provides characteristic of newly approved drug, results of clinical studies, post-approval clinical studies now underway or planned; cautions for use and rationale for their establishment, adverse reaction, clinical pharmacology, pharmacokinetics in humans; chemical structure; pharmacology, toxicology, etc.
SBA No.1: Irinotecan Hydrochloride
JPY4,894; 1996; pp.142; A4 format (210 x 297 mm); paperback;
ISBN4-8408-0420-6 C3047
SBA No.2: Sobuzoxane
JPY3,875; 1996; pp.70; A4 format (210 x 297 mm); paperback;
ISBN4-8408-0390-0 C3047
SBA No.3: Propagermanium
JPY3,875; 1996; pp.72; A4 format (210 x 297 mm); paperback;
ISBN4-8408-0387-0 C3047
SBA No.5: Carperitide
JPY3,885; 1997; pp.78; A4 format (210 x 297 mm); paperback;
ISBN4-8408-0455-9 C3047
SBA No.7: Nedaplatin
JPY4,384; 1996; pp.106; A4 format (210 x 297 mm); paperback;
ISBN4-8408-0421-4 C3047
Medical Device
Guide to Medical Device Registration in Japan, 7th Edition
JPY12,000; 2004; pp. 422; A4 format (210 x 297 mm); paperback; ISBN4-8408-0808-2 C3047
Cosmetics
Functional Cosmetology-Substantiation of Cosmetics Efficacy: Recent Progress and Future Promise-
JPY28,000; 2003; pp.611; B5 format (181 x 257 mm); paperback; ISBN4-8408-0737-X; Supervised by Katsuyuki Takeda, Shotaro Harada, Masanori Ando; Edited by Society of Cosmetic Chemists of Japan; Describes usefulness of cosmetics from psychological and dermatological viewpoints in PART 1. In PART 2, the most current evaluation techniques of cosmetics are introduced by the leading cosmetics researchers in Japan.
Others
Pharmaceutical Administration in Japan 2007
JPY5,000; 2007; pp. 364; B5 format (183×257 mm); paperbound; ISBN978-4-8408-1000-5 C3047; With the Pharmaceutical Affairs Law revised in 2002, the new systems for the core part of the pharmaceutical regulation have been implemented as follows: The system for sponsor-investigator clinical trials; the system to ensure safety of drugs and medical devices by introduction of biological product regulation; introduction of marketing business license; GMP compliance including overseas audit; the new regulation for medical devices according to their classification. Appendix: The Cosmetic Standards; GVP Ministerial Ordinance on Drugs, Quasi-drugs, Cosmetics and Medical Devices; GPSP Ministerial Ordinance on Drugs as well as on Medical Devices.
The Japanese Pharmaceutical Industry in the New Millennium
JPY9,000; 2001; pp.168; B5 format (181 x 257 mm); paperback; ISBN4-8408-0640-3 C3047; Provides recent trends of the Pharmaceutical Indusrty in Japan and analyzes the structure and problems in the Industry with strict and unique viewpoints of experts.
