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Biologics / Biotherapeutics / Biotechnology
- Genetically Engineered Organisms (Geo), Genetically Modified Organisms, Antibiotics, Vaccines, Peptides
- Szot, Robert. J.
- Davitt, John M.
- Gad, Shayne C.
- Galiher, Norma Jean
- Hite, Mark
- Mihalko, Paul J.
- Northup, Sharon J.
- Rodgers, Kathleen
- Sawin, Virginia L.
- Schuh, JoAnn C.L.
- Spainhour, Charles B.
See also:
CBER Guidances Guidelines
Points to Consider in use of Independent (Toxicology) Consultants
Toxicology Consultants subject scope: Biotechnology - The nonclinical safety study recommendations for the marketing approval of a pharmaceutical usually include single and repeated dose toxicity studies, reproduction toxicity studies, genotoxicity studies, local tolerance studies, and for drugs that have special cause for concern or are intended for a long duration of use, an assessment of carcinogenic potential.
RTCTox Toxicology Consultants Genetic Engineering | Biotechnology | Biologics; RTCTox Toxicology Consultants Genetically Engineered Organisms, Genetically Modified Organisms, Antibiotics, Vaccines, Peptides, Toxicology Consultant Biotechnology, Biotherapeutics, Biologics