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Regulatory Needs and Decision Contexts for Acute Oral Systemic...
... CBER regulates biological products for human use, such as vaccines, blood and blood products, allergenics, cellular and tissue products, and gene therapies . CBER's requirement is ...
Size: 945KB https://ntp.niehs.nih.gov/iccvam/meetings/at-models-2018/ppt/3-reinke.pdf -
Minutes: BSC; June 21-22, 2012
... for the suggestion and noted that the data are very challenging to interpret, particularly since many of the chemotherapy agents are used in combination with other therapies. Dr. ...
Size: 191KB https://ntp.niehs.nih.gov/sites/default/files/ntp/about_ntp/bsc/2013/june/minutes20130625_508.pdf -
DNTP Strategic Portfolio; BSC; Dec. 8, 2021
... toxicity testing to address potential concerns, such as those that may present with individuals exposed to HIV therapies across the lifespan or during different life stages. ...
Size: 249KB https://ntp.niehs.nih.gov/sites/default/files/ntp/about_ntp/bsc/2021/december/meeting_materials/2masten_bsc_508.pdf -
RoC Profile: Diethylstilbestrol; 15th RoC 2021
... also occurred in the past through the use of diethylstilbestrol to prevent miscarriages, as hormone replacement therapy, to treat prostate cancer, and in other medical therapies. ...
Size: 141KB https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/content/profiles/diethylstilbestrol.pdf -
RoC Profile: Estrogens, Steroidal; 15th RoC 2021
... These replace- ment therapies are used to treat symptoms of menopause, including menopause ... used in typical estrogen therapies, particularly in some oral contraceptive formulations. ...
Size: 161KB https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/content/profiles/estrogenssteroidal.pdf -
Background Document: RoC: Aristolochic Acids ; 2010
... In contemporary medicine, Aristolochia plant products have been used in therapies for ... In contemporary medicine, Aristolochia plant extracts have been used in therapies for ...
Size: 2.7MB https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/twelfth/2010/finalbds/aristolochic_acids_final_508.pdf -
RoC Background Document: Steroidal Estrogens; Dec. 13-14, 2000
... between the effects of estrogen- only and estrogen-progestin combination therapies. ... combination therapies; however, others have not had adequate information to do so. ...
Size: 1.7MB https://ntp.niehs.nih.gov/sites/default/files/ntp/newhomeroc/roc10/se_no_appendices_508be.pdf -
Research Concept: Cobalt; 2014
... Ingestion of excess vitamin (e.g., B12) supplements containing cobalt, prescribed cobalt therapies, and use of cobalt-containing prosthetics can all result in elevated exposure. ...
Size: 690KB https://ntp.niehs.nih.gov/sites/default/files/ntp/roc/concept_docs/2014/cobalt_508.pdf -
Poster Abstracts: Sept. 2010 ICCVAM Workshop on Vaccine Testing
... Michel Girard, Sushama Sontakke, Dean Smith Health Canada, Biologic and Genetic Therapies Directorate, Center for Vaccine Evaluation, Ottawa, Ontario, Canada The mouse ...
Size: 147KB https://ntp.niehs.nih.gov/iccvam/meetings/biologicswksp-2010/posterabstracts.pdf -
Presenter Biosketches: Sept. 2010 ICCVAM Workshop on Vaccine...
... McFarland is currently the Associate Director for Policy in the Office of Cellular, Tissue and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER), at ...
Size: 163KB https://ntp.niehs.nih.gov/iccvam/meetings/biologicswksp-2010/wkshpbiosketch.pdf
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