Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond

Toxicologic Pathology

Volumn 27, Issue 1, 1999, Pages 27-31

  Serabian, Mercedes A ^a   Pilaro, Anne M ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Biotherapeutics; Preclinical trials; S6 document; Toxicity testing

Indexed keywords

RECOMBINANT PROTEIN;

BIOTECHNOLOGY; CLINICAL RESEARCH; CONFERENCE PAPER; DRUG SAFETY; HUMAN; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; TOXICITY TESTING;

ANIMALIA;

EID: 0033024643     PISSN: 01926233     EISSN: None     Source Type: Journal    
DOI: 10.1177/019262339902700106     Document Type: Conference Paper

References (5)

1. Food and Drug Administration (November 1997). International Conference on Harmonisation: Guidance on preclinical safety evaluation of biotechnology-derived pharmaceuticals. Fed. Register 62: 61515-61519. Available at: http://www.cber.gov.
2. Henck JW, Hilbish KG, Serabian MA, Cavagnaro JA, Hendrickx AG, Agnish ND, Kung AHC, and Mordenti J (1996). Reproductive toxicity testing of therapeutic biotechnology agents. Teratology 53: 185-195.
3. Mazue G, Bertolero F, Garofano L, Brughera M, and Carminati P (1992). Experience with the preclinical assessment of basic fibroblast growth factor (bFGF). Toxicol. Lett. 64/65: 329-338.
4. Siegel JP, Gerrard T, Cavagnaro JA, Keegan P, Cohen RB, and Zoon K (1995). Development of biological therapeutics for oncologic use. In: Biological Therapy of Cancer, 2nd ed., VT Devita Jr, S Hellman, and SA Rosenberg (eds). J. B. Lippincott, Philadelphia, pp. 879-890.
5. Stromberg K, Chapekar MS, Goldman BA, Chambers WA, and Cavagnaro JA (1995). Regulatory concerns in the development of topical recombinant ophthalmic and cutaneous wound healing biologies. Wound Rep. Reg. 2: 155-164.