Zobrazeno 1 - 10
of 25
pro vyhledávání: '"Kathleen A. Funk"'
Autor:
LaRonda Morford, Ronee Baracani, Aurore Varela, Arun Tatiparthi, Mukesh Summan, Maralee McVean, Kathleen A. Funk
Publikováno v:
International Journal of Toxicology. 42:182-197
Recommendations on study designs that adequately evaluate the in-life effects leading to juvenile bone toxicity, the various imaging modalities that can aid interpretation of the bone effects, biomarkers that may be useful, and regulatory issues were
Autor:
Maureen T. O’Brien, JoAnn C. L. Schuh, Lyn M. Wancket, Sarah D. Cramer, Kathleen A. Funk, Nicolette D. Jackson, Kamala Kannan, Kevin Keane, Abraham Nyska, Serge D. Rousselle, Adrienne Schucker, Valerie S. Thomas, Stefan Tunev
Publikováno v:
Toxicologic Pathology. 50:512-530
Nonclinical implantation studies are a common and often critical step for medical device safety assessment in the bench-to-market pathway. Nonclinical implanted medical devices or drug-device combination products require complex macroscopic and micro
Autor:
Torrie A Crabbs, Maralee McVean, William J. Reagan, Martin Sanders, Laura Dill Morton, Kathleen A. Funk
Publikováno v:
International Journal of Toxicology. 38:228-234
A number of issues may arise during the conduct of a study which can complicate interpretation of in vitro and in vivo datasets. Speakers discussed the implications of differing interpretations and how to avoid complicating factors during study plann
Publikováno v:
Current Topics in Nonclinical Drug Development ISBN: 9780429027536
Current Topics in Nonclinical Drug Development
Current Topics in Nonclinical Drug Development
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5510300972b0369197c26e70e7e6ca8b
https://doi.org/10.1201/9780429027536-3
https://doi.org/10.1201/9780429027536-3
Autor:
JoAnn C. L. Schuh, Kathleen A. Funk
Publikováno v:
Toxicologic Pathology. 47:344-357
The development of biomaterials, medical device components, finished medical products, and 3-D printed and regenerative medicine products is governed by a variety of international and country-specific standards and guidelines. Of greatest importance
Autor:
Shambhunath Choudhary, Charlotte M. Keenan, Audrey Walker, Kimberly Maratea, Kathleen A. Funk, Imran M. Khan
Publikováno v:
Toxicologic Pathology. 46:1006-1012
The Standard for the Exchange of Nonclinical Data (SEND) is an implementation of the Study Data Tabulation Model for nonclinical studies that enables the U.S. Food and Drug Administration (FDA) to modernize and streamline the review process. As a res
Publikováno v:
Toxicologic Pathology ISBN: 9780429504624
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::09dc37729ef2f9529e68082635e14bce
https://doi.org/10.1201/9780429504624-4
https://doi.org/10.1201/9780429504624-4
Autor:
Harold M. Aberman, Brent G. Parks, Ralph-Heiko Mattern, Heber C. Crockett, Pedro A. Piza, Kevin L. Ohashi, Dale R. Peterson, Michael L. Hawes, Joseph I. Fernandez, Kathleen A. Funk, Pamela J. Lund
Publikováno v:
Journal of Shoulder and Elbow Surgery. 24:1764-1773
Background A new scaffold design combined with a peptide growth factor was tested prospectively for safety and for improved tendon healing in sheep. Methods The infraspinatus tendon was detached and then surgically repaired to the humerus using sutur
Publikováno v:
Journal of Applied Toxicology. 33:383-389
Female Fischer 344 (F344) rats were exposed to N-nitrosodiphenylamine (NDPA) by dietary feed at concentrations of 0, 250, 1000, 2000, 3000 or 4000 ppm for 5 days, 2, 4 and 13 weeks duration. Endpoints evaluated included clinical observations, body we
Publikováno v:
Journal of Toxicology and Environmental Health, Part A. 75:637-648
Female F344 rats were exposed to 4,4'-methylenebis(N,N'-dimethyl)aniline (MDA) by dietary feed at concentrations of 0, 50, 200, 375, 500, or 750 ppm for 5 d, 2 wk, 4 wk, and 13 wk duration. Endpoints evaluated included clinical observations, body wei