The Journal of Toxicological Sciences

The Journal of Toxicological Sciences

Online ISSN : 1880-3989
Print ISSN : 0388-1350
ISSN-L : 0388-1350

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Volume 21, Issue 5

Displaying 1-27 of 27 articles from this issue

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"S1-1 Thioredoxin/Adult T-Cell Leukemia-Derived Factor (ADF) and Redox Regulation (<SYMPOSIUM 1>Regulation of biological events and occurrence of toxicity with active oxygen species and NO)

Tetsuro Sasada, Hiroshi Sono, Junji Yodoi

1996 Volume 21 Issue 5 Pages 285-287
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_285

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"S2-1 STRATEGIC PROPOSALS FOR PREDICTING DRUG-DRUG INTERACTIONS DURING NEW DRUG DEVELOPMENT : BASED ON SIXTEEN DEATHS CAUSED BY INTERACTIONS OF THE NEW ANTIVIRAL SORIVUDINE WITH 5-FLUOROURACIL PRODRUGS (<SYMPOSIUM 2>Strategy how we can learn drug-drug interaction during the development of a new drug)

Tadashi WATABE

1996 Volume 21 Issue 5 Pages 299-300
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_299

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"S2-2 STRATEGIC PROPOSALS TO AVOID DRUG INTERACTIONS DURING DRUG DEVELOPMENT : A LESSON FROM A TERFENADINE-RELATED DRUG INTERACTION (<SYMPOSIUM 2>Strategy how we can learn drug-drug interaction during the development of a new drug)

Takashi ISHIZAKI, M.D. Ph.D.

1996 Volume 21 Issue 5 Pages 301-303
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_301

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"S2-3 STRATEGIC PROPOSALS TO AVOID TOXIC DRUG INTERACTIONS DURING NEW DRUG DEVELOPMENT : MOLECULAR TOXICOLOGY PROPOSALS (<SYMPOSIUM 2>Strategy how we can learn drug-drug interaction during the development of a new drug)

Tetsuya KAMATAKI, Tsuyoshi YOKOI, Yasuko YAMAYOSHI, Katsunori NAKAMURA ...

1996 Volume 21 Issue 5 Pages 305-308
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_305

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"S2-4 STRATEGIC PROPOSALS FOR AVOIDING TOXIC INTERACTIONS WITH DRUGS FOR CLINICAL USE DURING DEVELOPMENT AND AFTER MARKETING OF A NEW DRUG : PHARMACOKINETIC CONSIDERATION (<SYMPOSIUM 2>Strategy how we can learn drug-drug interaction during the development of a new drug)

Yuichi SUGIYAMA, Takafumi IWATSUBO, Kaoru UEDA, Kiyomi ITO

1996 Volume 21 Issue 5 Pages 309-316
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_309

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"S2-5 A PROPOSAL FOR AVOIDING TOXIC INTERACTIONS OF A DRUG UNDER DEVELOPMENT TO ESTIMATE INHIBITORY ABILITY ON THE DRUG METABOLIZING ENZYMES IN HUMAN LIVER (<SYMPOSIUM 2>Strategy how we can learn drug-drug interaction during the development of a new drug)

Hideyo NOGUCHI

1996 Volume 21 Issue 5 Pages 317-321
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_317

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Drug interactions can be divided into those involving the pharmacokinetics of a drug and those affecting the pharmacodynamic response to it. Following strategies should be considered for avoiding pharmacokinetic drug interactions of new chemical entities under development. 1. To estimate the major metabolic pathways (including metabolic activation) using human liver preparations. 2. To identify the enzyme systems participating in the major metabolic pathways. 3. To examine metabolic inhibition for other drugs and by other drugs. 4. To confirm a pharmacokinetic effect for the combined drugs in vivo.

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"S2-5-1) STRATEGIC PROPOSALS FOR AVOIDING TOXIC INTERACTIONS WITH DRUGS FOR CLINICAL USE DURING DEVELOPMENT AND AFTER MARKETING OF A NEW DRUG : PROPOSALS FOR DESIGNING NON-CLINICAL AND CLINICAL STUDIES : IS THE NON-CLINICAL STUDY USEFUL? (<SYMPOSIUM 2>Strategy how we can learn drug-drug interaction during the development of a new drug)

Naoki OZAWA

1996 Volume 21 Issue 5 Pages 323-329
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_323

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Since sorivudine incident has happened in Japan in 1993, an adverse drug-drug interaction has been of special meanings at each step of new drug development including the discovery step, NDA process, and on market. While it is known that several mechanisms are involved in the drug-drug interactions, the mechanisms related to drug metabolism are 1) inhibition of drug metabolizing enzymes, 2) induction of the enzymes, 3) drug absorption, 4) renal excretion, 5) hepatic transport, and 6) protein binding (displacement) interaction. In this report, proposals to avoid serious/lethal drug-drug interactions are presented with the examples. The proposals are: 1) To estimate the drug-drug interactions in consideration of the mechanisms reported so far, 2) To be especially careful for drugs with a small therapeutic index and sever/lethal toxicity, 3) To estimate the drug-drug interactions in consideration of physiological factors of patients, who receive drugs in combination, 4) Not to leave the mechanism unclear, when some data, which do not deny the critical drug-drug interactions, were obtained, and 5) To conduct the drug-drug interaction studies in humans in careful consideration of the safety.

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"S2-5-2) BASIC STRATEGY FOR AVOIDING DRUG INTERACTION DURING STAGE OF DRUG DEVELOPMENT : THE PROPOSALS RELATIVE TO PLANING OF NON-CLINICAL AND CLINICAL STUDIES HOW SHOULD IT BE THE PLANING OF CLINICAL TRIALS (<SYMPOSIUM 2>Strategy how we can learn drug-drug interaction during the development of a new drug)

Toru HORIE, Hiroshi NAKATA, Kenichi KUSUBE

1996 Volume 21 Issue 5 Pages 331-339
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_331

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Report 1 : CURRENT ISSUES WITH REGARD TO SINGLE DOSE TOXICITY STUDIES (<Session 1>Single Dose Toxicity and Repeated Dose Toxicity Studies)

Masaharu HASHIMOTO

1996 Volume 21 Issue 5 Pages 417-420
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_417

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Report 2 : ICH TOPIC "6 vs 12 MONTHS" FOR LONG-TERM REPEATED DOSE STUDIES IN DOGS (<Session 1>Single Dose Toxicity and Repeated Dose Toxicity Studies)

Toshihito KADOTA

1996 Volume 21 Issue 5 Pages 421-424
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_421

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Report 3 : CASE STUDIES DEFINING NON-TOXIC AND TOXIC DOSE OF PHARMACEUTICALS (<Session 1>Single Dose Toxicity and Repeated Dose Toxicity Studies)

Ichiro NAESHIRO

1996 Volume 21 Issue 5 Pages 425-435
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_425

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Report 1 : CURRENT STATUS OF IMPLEMENTATION OF THE ICH GUIDELINE IN JAPAN (<Session 2>Reproductive toxicities)

Masashi AKAIKE, Takayuki IWASE, Hiroyasu NARITA, Masanori SASAKI

1996 Volume 21 Issue 5 Pages 439-449
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_439

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Report 2 : STANDARD PROTOCOLS BASED ON THE ICH GUIDELINES FOR REPRODUCTIVE AND DEVELOPMENTAL TOXICITY STUDIES : AN INTERNATIONAL IMPLEMENTATION (<Session 2>Reproductive toxicities)

Masao HORIMOTO

1996 Volume 21 Issue 5 Pages 451-455
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_451

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Report 3 : ASSESSMENT OF MALE REPRODUCTIVE TOXICITY IN RATS UNDER ICH GUIDELINES (<Session 2>Reproductive toxicities)

Mark A. Ph. D. CUKIERSKI

1996 Volume 21 Issue 5 Pages 457-458
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_457

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Report 1 : HOW WILL THE GENOTOXICITY GUIDELINES FOR PHARMACEUTICALS BE CHANGED BY THE ICH AGREEMENT (<Session 3>Genotoxicity tests)

Toshio SOFUNI

1996 Volume 21 Issue 5 Pages 461-464
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_461

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Report 2 : A CASE STUDY : EVALUATION OF RESULTS AND SELECTION OF ADDITIONAL STUDIES (<Session 3>Genotoxicity tests)

Chie FURIHATA

1996 Volume 21 Issue 5 Pages 465-467
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_465

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Report 3 : CONSIDERATIONS REGARDING THE SELECTION OF A STANDARD BATTERY TEST (<Session 3>Genotoxicity tests)

Hiroyasu SHIMADA

1996 Volume 21 Issue 5 Pages 469-472
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_469

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Report 1 : TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS : S1, A ; Conditions which require carcinogenicity studies for pharmaceuticals S1, B ; Use of two rodent species S1, C ; Dose selection for carcinogenicity studies of pharmaceuticals (<Session 4>CARCINOGENlClTY STUDIES)

Toshimi USUI, Hiroshi MASUDA

1996 Volume 21 Issue 5 Pages 475-478
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_475

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Report 2 : ASSESSMENT OF CARCINOGENICITY USING TRANSGENIC ANIMALS (<Session 4>CARCINOGENlClTY STUDIES)

Kunitoshi Mitsumori, Akiyoshi Nishikawa

1996 Volume 21 Issue 5 Pages 479-482
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_479

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Report 3 : INITIATION-PROMOTION MODEL FOR ASSESSMENT OF CARCINOGENICITY : MEDIUM-TERM LIVER BIOASSAY IN RATS FOR RAPID DETECTION OF CARCINOGENIC AGENTS (<Session 4>CARCINOGENlClTY STUDIES)

Katsumi IMAIDA, Shoji FUKUSHIMA

1996 Volume 21 Issue 5 Pages 483-487
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_483

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Report 4 : CASE STUDY OF CARCINOGENICITY BY INITIATION-PROMOTION MODEL (<Session 4>CARCINOGENlClTY STUDIES)

Mamoru MUTAI, Toyohiko AOKI

1996 Volume 21 Issue 5 Pages 489-492
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_489

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Report 1 : STUDY DESIGN AND STATISTICAL ANALYSIS OF TOXICOKINETICS : A REPORT OF JPMA INVESTIGATION OF CASE STUDIES (<Session 5A>TOXICOKINETICS)

Toshiji IGARASHI, Tomokuni YABE, Kohsei NODA

1996 Volume 21 Issue 5 Pages 497-504
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_497

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Report 2 : POINTS TO BE CONSIDERED FOR CONDUCTING TOXICOKINETIC STUDIES UNDER GLP AND FOR VALIDATING ANALYTICAL METHODS (<Session 5A>TOXICOKINETICS)

Teruaki YUZURIHA, Kazumasa AIZAWA, Junya OKADA

1996 Volume 21 Issue 5 Pages 505-509
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_505

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Report 3 : FUTURE PROSPECTS FOR TOXICOKINETICS : ITS ABILITY TO PREDICT DRUG ADVERSE EVENTS IN HUMANS (<Session 5A>TOXICOKINETICS)

Yuichi SUGIYAMA, Kiyomi ITO, Mitsuhiro TSUDA, Ikuo HORII

1996 Volume 21 Issue 5 Pages 511-516
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_511

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Report 2 : THE POSSIBILITY OF PREDICTING TISSUE ACCUMULATION AFTER REPEATED DOSING USING A SINGLE-DOSE TISSUE DISTRIBUTION STUDY (<Session 5B>Repeated dose tissue distribution studies)

Kenji MIZOJIRI, Hideyo SHINDO, Yasuo OHNO

1996 Volume 21 Issue 5 Pages 523-527
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_523

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Report 1 : GENERAL PRINCIPLES AND THE RELEVANT CASES (<Session 6B>Safety assessment of biotechnology-derived pharmaceutical product.)

Eiji MAKI

1996 Volume 21 Issue 5 Pages 531-533
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_531

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Report 2 : PHARMACOKINETICS AND TOXICOKINETICS OF BIO-PHARMACEUTICALS : TECHNICAL PROBLEMS (<Session 6B>Safety assessment of biotechnology-derived pharmaceutical product.)

Mutsufumi KAWAI

1996 Volume 21 Issue 5 Pages 535-537
Published: December 20, 1996
Released on J-STAGE: February 21, 2008

DOIhttps://doi.org/10.2131/jts.21.5_535

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