Search Results - "Schechtman, Leonard"

Rodent cell transformation assays—A brief historical perspective by Schechtman, Leonard M.

“…► In vitro neoplastic transformation historically employed principally rodent cells. ► Syrian hamster embryo (SHE), BALB/c 3T3 and C3H 10T 1/2 cells were…”
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JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for detection of genotoxic carcinogens: II. Summary of definitive validation study results by Uno, Yoshifumi, Kojima, Hajime, Omori, Takashi, Corvi, Raffaella, Honma, Masamistu, Schechtman, Leonard M., Tice, Raymond R., Beevers, Carol, Boeck, Marlies De, Burlinson, Brian, Hobbs, Cheryl A., Kitamoto, Sachiko, Kraynak, Andrew R., McNamee, James, Nakagawa, Yuzuki, Pant, Kamala, Plappert-Helbig, Ulla, Priestley, Catherine, Takasawa, Hironao, Wada, Kunio, Wirnitzer, Uta, Asano, Norihide, Escobar, Patricia A., Lovell, David, Morita, Takeshi, Nakajima, Madoka, Ohno, Yasuo, Hayashi, Makoto

“…•JaCVAM organized an international validation study of in vivo rat comet assay.•The ultimate goal was to establish the OECD test guideline.•The assay…”
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JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for the detection of genotoxic carcinogens: I. Summary of pre-validation study results by Uno, Yoshifumi, Kojima, Hajime, Omori, Takashi, Corvi, Raffaella, Honma, Masamistu, Schechtman, Leonard M., Tice, Raymond R., Burlinson, Brian, Escobar, Patricia A., Kraynak, Andrew R., Nakagawa, Yuzuki, Nakajima, Madoka, Pant, Kamala, Asano, Norihide, Lovell, David, Morita, Takeshi, Ohno, Yasuo, Hayashi, Makoto

“…•JaCVAM-organized an international validation study of in vivo rat comet assay.•The ultimate goal was to establish the OECD test guideline.•The study protocol…”
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Cell transformation assays for prediction of carcinogenic potential: state of the science and future research needs by Creton, Stuart, Aardema, Marilyn J., Carmichael, Paul L., Harvey, James S., Martin, Francis L., Newbold, Robert F., O'Donovan, Michael R., Pant, Kamala, Poth, Albrecht, Sakai, Ayako, Sasaki, Kiyoshi, Scott, Andrew D., Schechtman, Leonard M., Shen, Rhine R., Tanaka, Noriho, Yasaei, Hemad

“…Cell transformation assays (CTAs) have long been proposed as in vitro methods for the identification of potential chemical carcinogens. Despite showing good…”
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Implementation of the 3Rs (refinement, reduction, and replacement): validation and regulatory acceptance considerations for alternative toxicological test methods by Schechtman, Leonard M

“…Toxicological testing in the current regulatory environment is steeped in a history of using animals to answer questions about the safety of products to which…”
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Meeting Report: Validation of Toxicogenomics-Based Test Systems: ECVAM-ICCVAM/NICEATM Considerations for Regulatory Use by Corvi, Raffaella, Ahr, Hans-Jürgen, Albertini, Silvio, Blakey, David H., Clerici, Libero, Coecke, Sandra, Douglas, George R., Gribaldo, Laura, Groten, John P., Haase, Bernd, Hamernik, Karen, Hartung, Thomas, Inoue, Tohru, Indans, Ian, Maurici, Daniela, Orphanides, George, Rembges, Diana, Sansone, Susanna-Assunta, Snape, Jason R., Toda, Eisaku, Tong, Weida, van Delft, Joost H., Weis, Brenda, Schechtman, Leonard M.

“…This is the report of the first workshop "Validation of Toxicogenomics-Based Test Systems" held 11-12 December 2003 in Ispra, Italy. The workshop was hosted by…”
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The safety assessment process--setting the scene: an FDA perspective by Schechtman, Leonard M

“…The process by which the US Food and Drug Administration (FDA) evaluates the safety/hazard potential of the products under its purview has evolved from a…”
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Strategy for genotoxicity testing and stratification of genotoxicity test results—report on initial activities of the IWGT Expert Group by Müller, Lutz, Blakey, David, Dearfield, Kerry L., Galloway, Sheila, Guzzie, Peggy, Hayashi, Makoto, Kasper, Peter, Kirkland, David, MacGregor, James T., Parry, James M., Schechtman, Leonard, Smith, Andrew, Tanaka, Noriho, Tweats, David, Yamasaki, Hiroshi

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The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): A review of the ICCVAM test method evaluation process and current international collaborations with the European Centre for the Validation of Alternative Methods (ECVAM) by STOKES, William S, SCHECHTMAN, Leonard M, HILL, Richard N

“…Over the last decade, national authorities in the USA and Europe have launched initiatives to validate new and improved toxicological test methods. In the USA,…”
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The FDA's regulatory role in the ICCVAM process by Schechtman, Leonard M, Stokes, William S

“…The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), a permanent body set forth in the ICCVAM Authorization Act of 2000…”
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ECVAM-ICCVAM: Prospects for future collaboration by SCHECHTMAN, Leonard M, STOKES, William S

“…The level and complexity of testing for hazard and risk assessment of marketed products and environmental agents has increased substantially over time,…”
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Evaluation of the rodent micronucleus assay by a 28-day treatment protocol: Summary of the 13th Collaborative Study by the Collaborative Study Group for the Micronucleus Test (CSGMT)/Environmental Mutagen Society of Japan (JEMS)-Mammalian Mutagenicity Study Group (MMS) by Hamada, Shuichi, Sutou, Sizuyo, Morita, Takeshi, Wakata, Akihiro, Asanami, Shougo, Hosoya, Satoko, Ozawa, Shigenari, Kondo, Koji, Nakajima, Madoka, Shimada, Hiroyasu, Osawa, Koichi, Kondo, Yasushi, Asano, Norihide, Sato, Sei-ichi, Tamura, Hironobu, Yajima, Nobuhiro, Marshall, Richard, Moore, Catherine, Blakey, David H., Schechtman, Leonard M., Weaver, James L., Torous, Dorothea K., Proudlock, Ray, Ito, Seiichi, Namiki, Chiaki, Hayashi, Makoto

“…To examine whether micronucleus tests can be incorporated into general toxicology assays, we performed micronucleus tests applying the treatment protocols…”
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ECVAM prevalidation study on in vitro cell transformation assays: General outline and conclusions of the study by Corvi, Raffaella, Aardema, Marilyn J., Gribaldo, Laura, Hayashi, Makoto, Hoffmann, Sebastian, Schechtman, Leonard, Vanparys, Philippe

“…► ECVAM prevalidated SHE and BALB/c 3T3 cell transformation assays (CTAs). ► Standardised protocols for CTAs are now available. ► Further testing should…”
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The JaCVAM international validation study on the in vivo comet assay: Selection of test chemicals by Morita, Takeshi, Uno, Yoshifumi, Honma, Masamitsu, Kojima, Hajime, Hayashi, Makoto, Tice, Raymond R, Corvi, Raffaella, Schechtman, Leonard

“…•Test chemicals were selected for the validation study of the in vivo comet assay.•Forty chemicals were selected based on carcinogenicity and genotoxicity…”
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Application of in vitro cell transformation assays in regulatory toxicology for pharmaceuticals, chemicals, food products and cosmetics by Vanparys, Philippe, Corvi, Raffaella, Aardema, Marilyn J., Gribaldo, Laura, Hayashi, Makoto, Hoffmann, Sebastian, Schechtman, Leonard

“…► Alternative ways for carcinogenicity testing are urgently required. ► Transformation, a key event of carcinogenesis, can be assessed by cell transformation…”
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Guidance on good cell culture practice. a report of the second ECVAM task force on good cell culture practice by Coecke, Sandra, Balls, Michael, Bowe, Gerard, Davis, John, Gstraunthaler, Gerhard, Hartung, Thomas, Hay, Robert, Merten, Otto-Wilhelm, Price, Anna, Schechtman, Leonard, Stacey, Glyn, Stokes, William

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ECVAM prevalidation of three cell transformation assays by Vanparys, Philippe, Corvi, Raffaella, Aardema, Marilyn, Gribaldo, Laura, Hayashi, Makoto, Hoffmann, Sebastian, Schechtman, Leonard

“…A prevalidation study on the cell transformation assays in SHE cells at pH 6.7, SHE cells at pH 7.0 and Balb/c 3T3 cell line was coordinated by ECVAM focussing…”
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Points of Reference in the Validation Process by Hoffmann, Sebastian, Edler, Lutz, Gardner, Ian, Gribaldo, Laura, Hartung, Thomas, Klein, Christoph, Liebsch, Manfred, Sauerland, Stefan, Schechtman, Leonard, Stammati, Annalaura, Nikolaidis, Efstathios

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ICH-Harmonised guidances on genotoxicity testing of pharmaceuticals: evolution, reasoning and impact by Müller, Lutz, Kikuchi, Yasumoto, Probst, Gregory, Schechtman, Leonard, Shimada, Hiroyasu, Sofuni, Toshio, Tweats, David

“…The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has convened an expert working…”
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Correlation of in vitro growth properties and tumorigenicity of Syrian hamster cell lines by Barrett, J C, Crawford, B D, Mixter, L O, Schechtman, L M, Ts'o, P O, Pollack, R

“…Several in vitro phenotypic characteristics frequently associated with neoplastic cells were examined in a series of spontaneous and benzo(a)pyrene-induced…”
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