Zobrazeno 1 - 10
of 41
pro vyhledávání: '"John L, Vahle"'
Autor:
John L. Vahle, Joe Dybowski, Michael Graziano, Shigeru Hisada, Jose Lebron, Thomas Nolte, Ronald Steigerwalt, Kenjiro Tsubota, Frank D. Sistare
Publikováno v:
Frontiers in Toxicology, Vol 6 (2024)
Industry representatives on the ICH S1B(R1) Expert Working Group (EWG) worked closely with colleagues from the Drug Regulatory Authorities to develop an addendum to the ICH S1B guideline on carcinogenicity studies that allows for a weight-of-evidence
Externí odkaz:
https://doaj.org/article/053d6740fba4457d80fc51a572935162
Autor:
Nancy Bower, William E. Achanzar, Virginie Boulifard, Peter R. Brinck, Birgit Kittel, John L. Vahle
Publikováno v:
International Journal of Toxicology. 41:431-441
The objective of the pharmaceutical industry is to develop new drugs that are safe for human use. In many cases, the accepted approach codified in guidance from regulatory authorities to assess the nonclinical safety profile of potential pharmaceutic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::10c8280d91d8e4206ca7f39a704c155a
https://doi.org/10.1177/10915818221125670
https://doi.org/10.1177/10915818221125670
Publikováno v:
Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2 : Safety Assessment Environmental Toxicologic Pathology ISBN: 9780128210475
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::400e794d9a63b2b1e9c099375fecf6fc
https://doi.org/10.1016/b978-0-12-821047-5.00022-1
https://doi.org/10.1016/b978-0-12-821047-5.00022-1
Autor:
Basel T. Assaf, Adam D. Aulbach, Virunya Bhat, Brad Bolon, William M. Bracken, Alys E. Bradley, Glenn H. Cantor, Kevin B. Donnelly, Elodie Drevon-Gaillot, Stephen K. Durham, Jeffery A. Engelhardt, Daniela Ennulat, James Fikes, John Reginald Foster, Kathleen Funk, Sibylle Gröters, Magali R. Guffroy, Silvia Guionaud, Katherine Hammerman, Carole Harbison, Claudia Harper, Christopher Hurst, Evan B. Janovitz, Kevin Keane, Stephanie Klein, Rebecca Kohnken, Michael W. Leach, Xiantang Li, René Meisner, Keith Nelson, Thomas Nolte, Arun R. Pandiri, Jonathan A. Phillips, Colin G. Rousseaux, Daniel G. Rudmann, Keegan C. Rudmann, Aaron M. Sargeant, JoAnn C.L. Schuh, A. Eric Schultze, Rani S. Sellers, James A. Swenberg, Eric Tien, John L. Vahle, Lyn M. Wancket, Charles E. Wood
Publikováno v:
Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2 : Safety Assessment Environmental Toxicologic Pathology ISBN: 9780128210475
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::31409643d62572b0c03a3aa33f1f4680
https://doi.org/10.1016/b978-0-12-821047-5.01002-2
https://doi.org/10.1016/b978-0-12-821047-5.01002-2
Autor:
Karyn, Colman, Rachel N, Andrews, Hannah, Atkins, Theresa, Boulineau, Alys, Bradley, Annamaria, Braendli-Baiocco, Raffaella, Capobianco, David, Caudell, Mark, Cline, Takuya, Doi, Rainer, Ernst, Eric, van Esch, Jeffrey, Everitt, Pierluigi, Fant, Margarita M, Gruebbel, Lars, Mecklenburg, Andew D, Miller, Kristen J, Nikula, Shigeru, Satake, Julie, Schwartz, Alok, Sharma, Akihito, Shimoi, Cécile, Sobry, Ian, Taylor, Vimala, Vemireddi, Justin, Vidal, Charles, Wood, John L, Vahle
Publikováno v:
Journal of Toxicologic Pathology
The INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions Project (www.toxpath.org/inhand.asp) is a joint initiative of the Societies of Toxicologic Pathology from Europe (ESTP), Great Britain (BSTP), Japan (JSTP) an
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::e526dcfd7f7a5de8fc7b019878f90472
https://pubmed.ncbi.nlm.nih.gov/34712008
https://pubmed.ncbi.nlm.nih.gov/34712008
Publikováno v:
Toxicologic pathology. 49(2)
The delivery of biotherapeutic molecules (antibodies, proteins, peptides) and nucleic acids via the respiratory route has presented challenges for regulatory approval, due in part to a lack of understanding of the expected pathology, mechanisms of to
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a1a2def2a517c0bd057d29bd367322d1
https://pubmed.ncbi.nlm.nih.gov/33397211
https://pubmed.ncbi.nlm.nih.gov/33397211
Autor:
John L. Vahle
Publikováno v:
Toxicologic Pathology. 45:845-850
In animal studies, light microscopic examination remains an important tool in the detection and characterization of effects on the skeleton. In the case of both anticipated and unanticipated effects on bone histology, pathologists must carefully sele
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b49e279991db9fe9b4805b8d0cdca88c
https://doi.org/10.1177/0192623317734511
https://doi.org/10.1177/0192623317734511
Autor:
Jamie L. Blackbourne, David E. Coutant, Julie S. Moyers, Owens Rebecca Anne, M. Dodson Michael, Richard A. Byrd, A. Eric Schultze, John L. Vahle, Michael K. Sievert, Niraj Tripathi, Mark W. Farmen
Publikováno v:
Regulatory Toxicology and Pharmacology. 88:56-65
Basaglar®/Abasaglar® (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus® (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We asse
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::da1e31f53c987023a1ffe89a88e5134b
https://doi.org/10.1016/j.yrtph.2017.05.013
https://doi.org/10.1016/j.yrtph.2017.05.013
Autor:
John L. Vahle
Publikováno v:
Toxicologic pathology. 46(8)
This article summarizes a continuing education presentation on immunogenicity that was part of a continuing education course entitled, “Clinical Pathology of Biotherapeutics.” Immunogenicity of a biotherapeutic can have diverse impacts including
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6438f674feceef96dc8800b7050ed682
https://pubmed.ncbi.nlm.nih.gov/30157708
https://pubmed.ncbi.nlm.nih.gov/30157708
Autor:
John L. Vahle
Haemophilus parasuis is a common cause of polyserositis and polyarthritis in swine. Little is known about the mucosal and systemic sites of replication and lesions following aerosol exposure to H. parasuis. In this experiment, 5 week old cesarean der
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::67d34ada35e072ee2827dbaa12524b75
https://doi.org/10.31274/rtd-180813-10389
https://doi.org/10.31274/rtd-180813-10389