Japanese Center for the Validation of Alternative Methods
Office : New Testing Method Assessment, Division of Pharmacology,
National Biological Safety Research Center (NBSRC),
National Institute of Health Sciences (NIHS)

JaCVAM Activities

Academic activities

Articles 　-- 2008 　-- 2007 　-- 2006

Presentations, Speeches 　-- 2010 　-- 2009 　-- 2008 　-- 2007 　-- 2006

Articles

-- 2008

• Nakazawa T, Kurokawa M, Kimura K, Wakata A, Hisada S, Inoue T, Sagami F, Heidel SM, Kawakami K, Shinoda K, Onodera H, Kumagai Y, Ohno Y, Kawamura N, Yamazaki T, Inoue T. Safety assessment of biopharmaceuticals: Japanese perspective on ICH S6 guideline maintenance. J Toxicol Sci 33:277-282, 2008
• Nakae D, Onodera H, Fueki O, Urano T, Komiyama N, Sagami F, Kai S, Nishimura C, Inoue T. Points to consider on the non-clinical safety evaluation of anticancer drugs. J Toxicol Sci 33:123-126, 2008
• Inoue T, Kodama Y. Future alternatives in "3Rs": Learning from history. Alternatives to Animal Testing and EXperimentation 14:257-260, 2008
• Hirabayashi Y, Inoue T. Principles of data-mining in toxicogenomics. In: Sahu SC, ed. Toxicogenomics: A Powerful Tool for Toxicity Assessment. Hoboken, NJ John Wiley & Sons, Ltd.: 57-84, 2008
• Takao Ashikaga1, Hitoshi Sakaguchi2, Kenji Okamoto1, Makoto Mizuno4, Jun Sato5, Takaaki Yamada6, Mayumi Yoshida7, Naoko Ota7, Seiji Hasegawa6, Tatsuji Kodama5, Yuko Okamoto4, Hirofumi Kuwahara3, Nanae Kosaka2, Sakiko Sono1, Yasuo Ohno: Assessement of the human cell line activation test (h-CLAT) for skin sensitization; Results of the first Japanese inter-laboratory study. AATEX 13, 27-35, 2008. (1: Shiseido Co. Ltd., 2: Kao Corp., 3: Kanebo Cosmetics inc., Kose Corp., 5: Lion Corp., 6: Nippon Menard Cosmetic Co., Ltd., 7: Pola Chemical Industries, Inc.)
• Kojima, H., JaCVAM: An organization supporting the validation and peer review of new alternatives to animal testing, WC6 proceedings, 483 (2008)
• Kojima, H., Perspectives on validation and regulatory acceptance of animal alternative testings in Japan, P&G Actives Risk Communication, 2(1), 1-4 (2008)
• Hajime Kojima, Tomoko Ando, Katsuhiro Inagaki, Mahito Ohhira, Tadashi Kosaka, Yosuke Nakamura, Hisashi Torishima, Noriyuki Morikawa, Jun Kanno, Mami Kuboki, Michiru Genno, Masaru Nokata, Takanori Harada, Takashi Morimoto, Isao Yoshimura, Yasuo Ohno, Validation of human skin models for skin corrosivity tests in Japan, Altern. Animal Test. EXperiment, 13(1), 36-44 (2008)
• Takashi Omori, Yoshiaki Ikarashi, Yukiko Kanazawa, Kenji Idehara, Hajime Kojima, Takashi Sozu, Kazunori Arima, Hirohiko Goto, Tomohiko Hanada, Taketo Inoda, Tadashi Kosaka, Eiji Maki, Takashi Morimoto, Shinsuke Shinoda, Naoki Shinoda, Masahiro Takeyoshi, Masashi Tanaka, Mamoru Uratani, Masahito Usami, Atsushi Yamanaka, Tomofumi Yoneda, Isao Yoshimura and Atsuko Yuasa, Validation studies on an alternative endpoint for the local lymph node assay (LLNA-DA): Importance of study management, WC6 proceedings, 429 (2008)
• Takashi Omori , Kenji Idehara , Hajime Kojima , Takashi Sozu , Kazunori Arima , Hirohiko Goto ,　Tomohiko Hanada , Yoshiaki Ikarashi , Taketo Inoda , Yukiko Kanazawa , Tadashi Kosaka , Eiji Maki ,Takashi Morimoto , Shinsuke Shinoda , Naoki Shinoda , Masahiro Takeyoshi , Masashi Tanaka ,　Mamoru Uratani , Masahito Usami , Atsushi Yamanaka , Tomofumi Yoneda ,Isao Yoshimura , Atsuko Yuasa, Interlaboratory validation of the modified murine local lymph node assay based on adenosine triphosphate measurement, Journal of Pharmacological and Toxicological Methods 58 11-26(2008)
• Arai, S., Yamamoto, N., Kato M., and Kojima, H.: An in vitro evaluation methods to test ocular irriation using a human corneal epithelium model, Altern. Animal Test. EXperiment, 13(2), 83-90 (2008)

-- 2007

• Hirabayashi Y, Inoue T. Implications of hemopoietic progenitor cell kinetics and experimental leukemogenesis: Relevance to Gompertzean mortality as possible hematotoxicological endpoint. Exp Hematol 35:125-133, 2007

-- 2006

• Hajime Kojima, Izumi Ishii, Satoru Nakata and Hiroaki Konishi, Dose-response evaluation using an Epidermal model, an alternative to skin irritation testing, Altern. Animal Test. EXperiment,11, 177-184 (2006)

Presentations, Speeches

-- 2010

• Kojima, H., Arai, S. and Hojyo, M.: Adequate conditions for performance of comet assay using 3-dimensional human epidermal model, 49th Annual SOT meeting, Salt Lake City (2010)
• W Stokes, M Wind, D Blakey, J Kreysa, H Kojima, E Anklam: Establishment of the International Cooperation on Alternative Test Methods (ICATM) and Its Role in the Validation and Regulatory Acceptance of Globally Harmonized Safety Assessment Methods, 49th Annual SOT meeting, Salt Lake City (2010)
• P Ceger, F Deal, D Allen, G Clark, P Pazos, J de Lange, S Bremer, M Nakamura, H Kojima, A Ono, R Tice, W Stokes, Testing of Coded Substances in the NICEATM/ECVAM/JaCVAM LUMI-CELL® STTA Multiphase International Validation Study, 49th Annual SOT meeting, Salt Lake City (2010.3)

-- 2009

• Kojima, H., Current aspects of LLNA-DA and LLNA-BrdU as alternatives for skin sensitizer classification in Japan, 2009 Winter Conference of　Korean Society of Alternatives to Animal Experiments, Seoul (February, 2009)
• R Tice, F Deal, P Ceger, D Allen, J Gordon, J DeLange, S Bremer, M Nakamura, H Kojima, A Ono and W Stokes: Establishing a Historical Database for a Multi-phased International Validation Study of a Stably-Transfected Estrogen Receptor (ER) Transcriptional Activation (TA) Test Method, 48th Annual SOT meeting, Baltimore (2009)
• J Strickland, M Paris, D Allen, R Tice, H Kojima, P Prieto, M Wind and W Stokes: ICCVAM/NICEATM/ECVAM/JaCVAM Scientific Workshop on Acute Chemical Safety Testing: Advancing In Vitro Approaches and Humane Endpoints for Acute Systemic Toxicity Evaluations, 48th Annual SOT meeting, Baltimore (2009)
• Kojima, H.：3D comet assay, JaCVAM experience, 5th International Workshop on Genotoxicity Testing, Basel (2009)
• Kojima, H., Yamakage, K., Burlinson, B., Escober, P., Pant, K., Kraynak, A., Hayashi, M., Corvi, R., Uno, Y., Schechtman, L., Tice, R. and Honma, M.: International validation study of the in vitro alkaline comet assay, 8th International Comet Assay Workshop, Perugia (2009)
• Nakajima, M., Masumori, S., Tanaka, J., Hayashi, M., Uno, Y., Kojima, H. and Tice, R.: An atlas of comet images: JaCVAM initiative International Validation trial for the in vivo comet assay, 8th International Comet Assay Workshop, Perugia (2009)
• Kojima, H.：Validation of innovative methods for safety testing: drawbacks and advantages of Japanese validation studies, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Kojima, H., Matsui, T., Kohara, A., Yoshida, A. and Nakamura, Y.: GCCP initiatives in Japan, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Ono, A., Takeyoshi, M., Bremer, S., Jacob, M., Laws, S., Sozu, T. and Kojima, H.: The International validation study for the ER alpha STTA antagonist assay using HeLa9903, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Allen, D., Deal, F., Ceger, P., Gordon, J., Pazos, P., deLange, L., Bremer, S., Nakamura, M., Kojima, H., Ono, A., Tice, R. and Stokes W.: Testing of coded substances for a multi-phases international validation study of an estorogen receptor (ER) transcriptional activation (TA) assay, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Kojima, H., IIjima, M., Matsunaga, K., Sasa, H., Itagaki, H., Okamoto, Y., Nishiyama, N., Mita I., Washida, J., Masuyama, K., Onodera, H., Masuda, M. and Ohno, Y.: Review of an alternative to animal testing for safety evaluation of cosmetic ingredients using Quasi-drug, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Wind, M., Blakey, D., Kojima, H., Kreysa, J. and Stokes, W.: What is the international cooperation on alternative test methods (ICATM) and what is its role?, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Kojima, H.：JaCVAM’s role in the 3Rs and ICATM, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Kojima, H.：Recent progress and future directions at JaCVAM, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Inoue, T., Masuda, M., Akita. M., Kojima, H. and Ohno, Y.: JaCVAM statement on new alternative to animal testing, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Takeyoshi, M., Kojima, H., Omori, T., Sozu, T. and Yoshimura, I.: Validation study for non-radioisotopic local lymph node assay based on BrdU incorporation (LLNA-BrdU), 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Kojima, H., Ando, Y., Yamaguchi, Y., Kosaka, T., Suzuki, T., Yuasa, A., Watanabe, Y., Shinoda, S., Idehara, K., Yoshimura, I., Miyaoka, E., Ishiyama, K., Kato, M. and Omori, T. : Validation of LabCyte EPI-MODEL24, an In Vitro Assay for Detecting Skin Irritants, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Yamamoto, N., Hirano, K., Kato, M., Hata, K., Horiguchi, M., Taniguchi, K. and Kojima, H.: Cell surface maker of corneal epithelium stem cells and culture, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Lowther, D., Wind, M., Stokes, W., Barroso, J., Zuang, V., Amcoff, P., Kojima, H., Prinsen, M., Tice, R., Allen, D. and McCall, D.: International acceptance of in vitro alternative ocular safety testing methods: the isolated chicken eye (ICE) test method (Draft OECD TG 438), 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Merrill, J., Wind, M., Stokes, W., Barroso, J., Zuang, V., Amcoff, P., Kojima, H., Jacobs, A., McCall, D. Allen D. and Tice, R.,: International acceptance of in vitro alternative ocular safety testing methods: bovine corneal opacity and permeability (BCOP) test method (Draft OECD TG 437), 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Hayashi, M., Uno, Y., Honma, M., Schectmann, L., Tice, R., Corvi, R., Morita, T., Asano, N. and Kojima, H.: In vivo Comet Assay: Update on the on-Going international validation study, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Honma, M., Kojima, H., Morita, T., Uno, Y., Asano, N., Nakajima, M., Corvi, R., Tice, R., Schectman, L. and Hayashi, M.: Intenational validation study of the in vitro alkaline comet assay, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Kojima, H., Arai S. and Hojyo M.: Adequate conditions for performance of comet assay using 3-dimensional human epidermal model, 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Stokes, W., Wind, M., Matheson, J., Jacob., A., Casati, S., Kojima, H., Allen, D., Burns, T., Salicru, E., Strickland, J. and Tice, R., Internationally harmonized performance standards (PS) for the murine local lymph node assay (LLNA), 7th World Congress on Alternatives & Animal Use in the Life Sciences, Rome（2009）
• Honma, M., Kojima, H., Morita, T., Uno, Y., Asano, N., Nakajima, M., Corvi, R., Tice, R., Schectman, L. and Hayashi, M.: Intenational validation study of the in vitro alkaline comet assay, 25th ICEM , Florence（2009）
• Uno, Y., Kojima, H., Honma, M., Schectmann, L., Tice, R., Corvi, R., Morita, T., Asano, N. and Hayashi, M.: In vivo Comet Assay: Update on the on-Going international validation study, 25th ICEM , Florence（2009）
• Hajime Kojima: Japanese views in the 3Rs in the 21st century, ZEBET's 20th Anniversary Symposium, Berlin, Germany (2009)
• Hajime Kojima: Organization of JaCVAM and its activity, KoCVAM International Symposium and 6th Congress of KSAAE, Seoul (2009)
• Hajime Kojima: Utilization of an alternative to animal testing for safety evaluation of cosmetic ingredients using Quasi-drug, The 17th ICDS (International Contact Dermatitis Symposium) and the 10th APEODS (Asia-Pacific Environmental and Occupational Dermatology Symposium), Kyoto (2009)
• Hajime Kojima:Japanese approach to regulatory acceptance of new skin sensitization testings with due considerations to animal welfare and 3Rs, The 17th ICDS (International Contact Dermatitis Symposium) and the 10th APEODS (Asia-Pacific Environmental and Occupational Dermatology Symposium), Kyoto (2009)
  

-- 2008

• Kojima, H., The Importance of the in vivo comet assay in genotoxicity testing, Predictive Human Toxicity and ADME/TOX studies, 3rd Annual conference of Mondial Research Presentation, Brussels (2008)
• Kojima, H., et al., Panel Discussion, ICCVAM Tan-Year Anniversary Symposium, Washington DC (2008)
• Kojima, H.,　Opening remark, Workshop　on Acute chemical safety testing: Advancing in vitro approaches and Humane Endpoints for systemic Toxicity Evaluation, Washington, DC (2008)
• Hajime Kojima, Masahiro Takeyoshi Takashi Omori, Takashi Sozu, Kazunori Arima, Kenji Idehara, Yoshiaki Ikarashi, Yukiko Kanazawa, Eiji Maki, Naoto Nakagiri, Masashi Tanaka, Atsuko Yuasa, and Isao Yoshimura, Inter-laboratory validation study on LLNA-BrdU, 47th Annual SOT meeting, Seattle (2008)
• Kojima, H., Report JaCVAM, ECVAM Scientific Advisory Committee, Ispra (May,2008)
• Kojima, H.,　Japanese Collaboration on Alternative to Animal Toxicology Testing, World Congress on in Vitro Biology, Tucson (2008)
• Kojima, H., JaCVAM Update, Scientific Advisory Committee on Alternative Toxicological Methods, Bethesda, (June, 2008)
• Kojima, H., Report JaCVAM, ECVAM Scientific Advisory Committee, Brussels (November, 2008)
• Kojima, H., International Current of 3Rs International Symposium　on the 3Rs Promotion in Asia、Saitama（2008）

-- 2007

• Kenji Idehara, Takashi Omori, Hajime Kojima, Takashi Sozu, Kazunori Arima, Hirohiko Goto, Tomohiko Hanada, Yoshiaki Ikarashi, Taketo Inoda, Yukiko Kanazawa, Tadashi Kosaka, Eiji Maki, Takashi Morimoto, Shinsuke Shinoda, Naoki Shinoda, Masahiro Takeyoshi, Masashi Tanaka, Mamoru Uratani, Masahito Usami, Atsushi Yamanaka, Tomofumi Yoneda, Isao Yoshimura, Atsuko Yuasa, Validation of LLNA-DA assay for assessing skin sensitization potential, 46th SOT, North Carolina (2007)
• WS Stokes, S Bremer, M Jacobs, H Kojima, J Kanno, P Ceger, FH Deal, RR Tice, NICEATM/ECVAM/JaCVAM Multi-phased International Validation Study of a Stably-Transfected Estrogen Receptor (ER) Transcriptional Activation (TA) Test Method. 46th SOT, North Carolina (2007)
• Kojima, H., JaCVAM Update, Scientific Advisory Committee on Alternative Toxicological Methods, Bethesda, (June, 2007)
• Kojima, H. JaCVAM Update, 6th　World Congress on Alternatives 6 Animal Use in the Life Sciences, p.119,Tokyo (2007)
• Kojima, H. JaCVAM Process to Validate and Peer Review of New Alternative Methods, 6th　World Congress on Alternatives 6 Animal Use in the Life Sciences, p.82, Tokyo (2007)
• Kojima, H. Validation study using Japanese models, 6th　World Congress on Alternatives 6 Animal Use in the Life Sciences, p.64, Tokyo (2007)
• Arai, S., Yamamoto, N. and Kojima, H., Safety evaluation test using a human cultured epidermal model- with the ECVAM validation proposal and chemicals-, 6th　World Congress on Alternatives 6 Animal Use in the Life Sciences, p.224. Tokyo (2007)
• Kojima, H., Arai, S., Kubo, K. and Kato M., Dose-response evaluation using a coreal model, an alternative to Draize eye irritation testing, 6th　World Congress on Alternatives & Animal Use in the Life Sciences, p.223,Tokyo (2007)
• Yamamoto, N, Kojima, H., Tanikawa, A. and Horiguchi, M., A study of retinal regulative medicine by human iris tissue cells, 6th　World Congress on Alternatives & Animal Use in the Life Sciences, p.103, Tokyo (2007)
• Yoshiaki Ikarashi, Takashi Omori, Yukiko Kanazawa, Kenji Idehara, Hajime Kojima, Takashi Sozu, Kazunori Arima, Hirohiko Goto, Tomohiko Hanada, Taketo Inoda, Tadashi Kosaka, Eiji Maki, Takashi Morimoto, Shinsuke Shinoda, Naoki Shinoda, Masahiro Takeyoshi, Masashi Tanaka, Mamoru Uratani, Masahito Usami, Atsushi Yamanaka, Tomofumi Yoneda, Isao Yoshimura and Atsuko Yuasa, First Inter-laboratory validation study on LLNA-DA, 6th　World Congress on Alternatives 6 Animal Use in the Life Sciences, p.254, Tokyo (2007)
• Yukiko Kanazawa, Takashi Omori, Yoshiaki Ikarashi, Kenji Idehara, Hajime Kojima, Takashi Sozu, Kazunori Arima, Hirohiko Goto, Tomohiko Hanada, Taketo Inoda, Tadashi Kosaka, Eiji Maki, Takashi Morimoto, Shinsuke Shinoda, Naoki Shinoda, Masahiro Takeyoshi, Masashi Tanaka, Mamoru Uratani, Masahito Usami, Atsushi Yamanaka, Tomofumi Yoneda, Isao Yoshimura and Atsuko Yuasa, Second Inter-laboratory validation study on LLNA-DA, 6th　World Congress on Alternatives 6 Animal Use in the Life Sciences, p.255, 6th　World Congress on Alternatives 6 Animal Use in the Life Sciences, Tokyo (2007)
• Takashi Omori, Yoshiaki Ikarashi, Yukiko Kanazawa, Kenji Idehara, Hajime Kojima, Takashi Sozu, Kazunori Arima, Hirohiko Goto, Tomohiko Hanada, Taketo Inoda, Tadashi Kosaka, Eiji Maki, Takashi Morimoto, Shinsuke Shinoda, Naoki Shinoda, Masahiro Takeyoshi, Masashi Tanaka, Mamoru Uratani, Masahito Usami, Atsushi Yamanaka, Tomofumi Yoneda, Isao Yoshimura and Atsuko Yuasa, Validation studies on LLNA: Importance of study management,　 6th　World Congress on Alternatives & Animal Use in the Life Sciences, p.264, Tokyo (2007)
• Stokes, W. S., Bremer, S., Jacobs, M., Ono A., Kojima, H., Ceger, P., Deal F. and Tice, R., NICVEATM/ECVAM/JaCVAM Multi-phase International validation study of an in vitro estrogen receptor transcriptional activation assay to detect agonist and antagonist activity, 6th　World Congress on Alternatives & Animal Use in the Life Sciences, p.265, Tokyo (2007)
• Kojima, H., JaCVAM Update, ECVAM Scientific Advisory Committee, Ispra (November ,2007)
• Kojima, H., International Validation Study of Non Animal Screening Assay for Endocrine Disrupter、2007　National Institute of Toxicological　Research　International　Symposium, Korea（2007）
• Arai, S., Saitou, M., Takashima, Y. Honma, M. and Kojima, H., Anew trial for in vitro Comet assay using a 3-dimensional human epidermal model, 36th Annual Meetings of the Japanese Environmental Mutagen Society, Kitakyusu (2007)
• Kojima, H., et al, Validation and implementation, Round table on International aspects of validation & accept, Regulatory Acceptance and Implementation of 3R approach, Annual Conference 2007 EPAA, Brussels (2007)

-- 2006

• H. Kojima, Current activities on alternative research in Japan, KSOT/KEMS Spring Annual Meeting, Alternative Toxicology and Marine Ecotoxicology, Korea(2006)
• H. Kojima, 6th World Congress on Alternatives ＆ Animal Use in the Life Sciences, Symposium on Laboratory Animal & Biosafety, 2nd International Forum on Laboratory Animal Science and Technology, Beijing (2006)
• H. Kojima, Evaluation of skin toxicity using 3-dimensional cultured skin model, the 19th annual and International Meeting of the Japanese Association for Animal Cell Technology, Kyoto (2006)
• H. Kojima, JaCVAM Update, Scientific Advisory Committee on Alternative Toxicological Methods, North Carolina (2006)