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FDA Update on Advancing Alternatives for Regulatory Use
- Animal studies play a critical role to meet this need and bring safe and effective therapies to patients FDA has a long-standing commitment to replace, reduce and refine ("3Rs") ...
Size: 2.5MB https://ntp.niehs.nih.gov/iccvam/meetings/iccvam-forum-2022/present/07_strauss_508.pdf -
Nomination of BioSentinel Methods for Detection of Botulinum...
Pharmaceutical manufacturing of BoNT-based therapies and cosmetics accounts for an estimated 600,000 animal deaths per year (Adler, 2010). . Development of new BoNT-based therapies ...
Size: 1.7MB https://ntp.niehs.nih.gov/iccvam/methods/biologics/biosentinel/biosentinelcover-508.pdf -
Tissue Chips for Drug Screening Program (ICCVAM 2023 Public Forum...
risk assessment to accurately evaluate the efficacy, safety and toxicity of promising therapies https://ncats.nih.gov/tissuechip . Represents 10 Major Organ Systems . Circulatory . ...
Size: 4.9MB https://ntp.niehs.nih.gov/sites/default/files/2023-06/22_tagle_iccvamforum2023_508.pdf -
RoC Background Document: Cyclosporin A; Nov. 18-19, 1996
3.2.2 CsA, Possibly Other Immunosuppressive Therapies ...... 12 3.2.3 CsA in Combination with Other Immunosuppressive Therapies......
Size: 4.9MB https://ntp.niehs.nih.gov/sites/default/files/ntp/newhomeroc/other_background/cyclosporin_a1_508.pdf -
Measuring U.S. Federal Agency Progress Toward Implementation...
... Scientists also use animals to study basic biological processes (e.g., biochemistry, physiology, behavior), or to develop therapies for diseases. This practice is often referred to ...
Size: 617KB https://ntp.niehs.nih.gov/iccvam/docs/about_docs/iccvam-measuringprogress-feb2021-fd-508.pdf -
Agenda: ICCVAM Public Forum 2023
Break 11. National Cancer Institute . In Vitro Co-culture Assays to Assess Safety of CAR-T Cell Therapies Shari Price 12. NICEATM Computational Tools Update Kamel Mansouri 13. Day ...
Size: 88KB https://ntp.niehs.nih.gov/iccvam/meetings/iccvam-forum-2023/publicforum2023-agenda-draft-public.pdf -
Chemical Exposures and Impacts at the Local Public Health Level...
Public Health practitioners address developmental disabilities in a broad swath Not all kids receive referrals for therapies to improve outcomes - numbers are under-reported Most ...
Size: 2.8MB https://ntp.niehs.nih.gov/iccvam/meetings/popvar-2022/ppt/02_tan_508.pdf -
FDA Guidance: Considerations for Plasmid DNA Vaccines for Infectious...
... INDs for these products should be submitted to CBER's Office of Cellular, Tissue and Gene Therapies (OCTGT). 1 Contains Nonbinding Recommendations FDA's guidance documents, ...
Size: 114KB https://ntp.niehs.nih.gov/iccvam/suppdocs/feddocs/fda/fda_plasdnavac.pdf -
US Department of Veterans Affairs (VA)(ICCVAM 2023 Public Forum...
An organotypic microfluidic model of the tumor microenvironment for preclinical assessment of novel therapies against ovarian cancer. Engineered 3D microfluidic tubular device as ...
Size: 457KB https://ntp.niehs.nih.gov/sites/default/files/2023-06/07_lathrop_iccvamforum2023_508.pdf -
Measurement assurance for cell counting (ICCVAM 2024 Public Forum...
... MISSION: Convene stakeholders in the pre- competitive space to accelerate the adoption of quantitative flow cytometry in biomanufacturing of cell and gene therapies. Contact: Lili ...
Size: 1.9MB https://ntp.niehs.nih.gov/sites/default/files/2024-06/06_Petersen_ICCVAMForum2024_508.pdf
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