Nihs.go.jp

Division of Drugs|National Institute of Health Sciences

WebLab Projects. The division consists of four sections engaged in research work related to chemical analysis and pharmaceutical (biological and physico-chemical) evaluation of …

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URL: https://www.nihs.go.jp/drug/index-E.html

National Institute of Health Sciences

WebThe National Institute of Health Sciences(NIHS), which was established in Tokyo in 1874 as the Tokyo Drug Control Laboratory (later renamed the Tokyo Institute of Hygienic …

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Japanese Pharmacopoeia

WebThe cautions on use. "The Japanese Pharmacopoeia Eighteenth Edition Name and Structure Database" is a database which is being developed by Division of Medicinal …

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Japan Existing Chemical Database (JECDB)

WebJapan Existing Chemical Database (JECDB) - National Institute of Health Sciences. Background to the Publication of Toxicity Testing Reports for Environmental Chemicals …

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National Institute of Health Sciences

WebWe perform the testing, research, and examinations to ensure the quality and safety of food additives and food contact materials. Our main research themes are development of …

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JAN: Japanese Accepted Names for Pharmaceuticals

WebThe Japanese Pharmacopoeia Eighteenth Edition (JP18) Name and Structure Database. Contact Information for Japanese Accepted Names (JAN) Name and Structure Database.

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National Institute of Health Sciences

WebDIVISION OF FOOD SAFETY INFORMATION. 1F. DIVISION OF MEDICINAL SAFETY SCIENCE. 4F. HEAD OF BIOLOGICAL SAFETY RESEARCH CENTER. 2F. DIVISION …

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National Institute of Health Sciences (NIHS), Center for Biological

WebThe CBSR (formerly known as Biological Safety Research Center, BSRC) of the NIHS was established on December 28, 1977 as the National Institute of Hygienic Sciences …

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Recent Regulatory Developments in Japan for Ensuring the …

WebYoji SATO, PhD. Head, Division of Cell-Based Therapeutic Products National Institute of Health Sciences 3-25-26 Tonomachi, Kawasaki Ward, Kawasaki 210-9501, …

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Division of Genome Safety Science, National Institute of Health

Web2024.04.01. Division of Genome Safety Science was established with organizational reform. This webpage will be updated soon. 2024.01.23. The 2nd …

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GUIDELINES FOR THE DESIGN AND EVALUATION OF ORAL …

WebThe present guidelines are prepared for oral prolonged release dosage forms, mainly for drugs with new pharmaceutical forms. However, many of the general principles of the …

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Bioanalytical Method Validation in Japan

WebJapanese. Purpose. The purpose of this web site is to provide the information about bioanalytical method validation (BMV) and to boost its discussions in Japan. Topics. …

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Guideline for Bioequivalence Studies for Different Strengths of …

WebSection 1: Introduction. This guideline describes the principles of procedures of bioequivalence studies for post-approval changes in the components and composition of …

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Guideline for Bioequivalence Studies for Different Strengths of

WebThis guideline describes the principles of procedures of bioequivalence studies for oral solid drug products which are the same in active ingredient, dosage form, therapeutic …

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Guideline for Bioequivalence Studies of Generic

WebSection 1: Introduction. This guideline describes the principles of procedures of bioequivalence studies of generic products. The objective of the study is to assure …

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Guideline for Bioequivalence Studies of Generic Products

Web1 English translation of Attachment 1 of Division-Notification 0229 No. 10 of the Pharmaceutical and Food Safety Bureau, dated February 29, 2012 Guideline for …

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Guideline for Bioequivalence Studies of Generic Products Q

Web3 product to the reference product are within the range of log 0.90 to log 1.11 on the condition that dissolution test results should indicates very low possibility of bio …

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