YAKUJINIPPO’s English Publications


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New Titles

Supplement II to the Japanese Pharmacopoeia Sixteenth Edition (Supplement II to JP XVI)

JPY 22,000; 2014; 296 pages; A4 Format (210 x 297 mm); Paperback; ISBN978-4-8408-1283-2 C3047; Published by Pharmaceutical and Medical Device Regulatory Science Society of Japan

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Official Monographs provide approx. 230 articles, including 60 articles newly added, 1 article deleted and 173 articles revised. General Tests, Processes and Apparatus provides the following test newly added: 2.61 Turbidity Measurement. Revision has been made on the following 7 tests. 1.11 Arsenic Limit Test; 2.25 Infrared Spectrophotometry; 5.01 Crude Drugs Test; 6.02 Uniformity of Dosage Units; 6.06 Foreign Insoluble Matter Test for Injections; 7.02 Test Methods for Plastic Containers; 7.03 Test for Rubber Closure for Aqueous Injections. Addenda include the following: The monographs revised in the Supplement II to JP16 and their revised sections, PMRJ Reference Standards Ordering Information for Foreign Users, PMRJ Reference Standards Catalog; PMRJ Reference Standards Order/Quote Request Form; and PMRJ Reference Standards Information for Users.

Pharmaceuticals

The Japanese Pharmacopoeia Sixteenth Edition (JP XVI)

JPY 72,000; 2012; 2320 pages; A4 Format (210 x 297 mm); Paperback; ISBN978-4-8408-1202-3 C3047; Published by Pharmaceutical and Medical Device Regulatory Science Society of Japan

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Official Monographs provides 1764 articles, including 106 articles newly added, 15 articles deleted and 330 articles revised. Main features and revisions of this book are: Full revision of General Rules for Preparations, including the classification of dosage forms by administration route and application site, etc., the addition of 43 dosage forms, and the change of the definitions; Revision of General Notices, Official Monographs and General Information on Water for Pharmaceutical Use, etc. General Tests, Processes and Apparatus which were revised are 2.01 Liquid Chromatography, 2.46 Residual Solvents Test, 2.51 Conductivity Measurement, 2.54 pH Determination, 2.58 X-Ray Powder Diffraction Method, 3.01 Determination of Bulk and Tapped Densities, 4.01 Bacterial Endotoxins Test, 4.05 Microbial Limit Test, 4.06 Sterility Test, 5.02 Microbial Limit Test for Crude Drugs, 6.03 Particle Size Distribution Test for Preparations, 6.07 Insoluble Particulate Matter Test for Injections, 6.08 Insoluble Particulate Matter Test for Ophthalmic Solutions, 7.02 Test Methods for Plastic Containers, and 8.01 Sterilization and Aseptic Manipulation.

Supplement I to the Japanese Pharmacopoeia Sixteenth Edition (Supplement I to JP XVI)

JPY 24,000; 2013; 332 pages; A4 Format (210 x 297 mm); Paperback; ISBN978-4-8408-1238-2 C3047; Published by Pharmaceutical and Medical Device Regulatory Science Society of Japan

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Official Monographs provide approx. 250 articles, including 77 articles newly added, 4 articles deleted and 176 articles revised. General Tests, Processes and Apparatus provides the following tests newly added: 2.62 Mass Spectrometry, and 2.63 Inductively Coupled Plasma-Atomic Emission Spectrometry and Inductively Coupled Plasma-Mass Spectrometry. Revision has been made on the following 6 tests. 2.22 Fluorometry; 2.47 Osmolarity Determination; 2.49 Optical Rotation Determination; 3.01 Determination of Bulk and Tapped Densities; 4.01 Bacterial Endotoxins Test; 6.10 Dissolution Test. Addenda include the following: The monographs revised in the Supplement I to JP16 and their revised sections, PMRJ Reference Standards Ordering Information for Foreign Users, PMRJ Reference Standards Catalog; PMRJ Reference Standards Order Form, and PMRJ Reference Standards User Information.

The Japanese Pharmacopoeial Forum (JPF) (Bilingual in Japanese/English)

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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)

[PDF 408KB][Correction]

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.


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