Developmental toxicity testing of vaccines

Methods in Molecular Biology

Volumn 947, Issue , 2013, Pages 81-89

  Barrow, Paul C ^a   Allais, Linda ^b  

^a SOLVO BIOTECHNOLOGY   (Hungary)

^b Ricerca Biosciences   (France)

Author keywords

DART; Developmental toxicology; Preclinical methods; Teratology; Vaccines

Indexed keywords

ANIMALIA; ORYCTOLAGUS CUNICULUS; PRIMATES; RODENTIA;

EID: 84871903901     PISSN: 10643745     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-62703-131-8_7     Document Type: Article

References (13)

1. Centers for Disease Control and Prevention (2009) Use of in fluenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 58:1-8
2. Raghupathy R (1997) Th1-type immunity is incompatible with successful pregnancy. Immunol Today 18:478-482
3. Verdier F, Barrow PC, Bruge J (2003) Reproductive toxicity testing of vaccines. Toxicology 185:213-219
4. Ryan MA, Gumbs GR, Conlin AM, Sevick CJ, Jacobson IG, Snell KJ, Spoone T, Smith TC (2008) Evaluation of preterm births and birth defects in liveborn infants of US military women who received smallpox vaccine. Birth Defects Res A Clin Mol Teratol 82: 533-539
5. FDA (2006) Guidance for industry: considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications. http://www.fda.gov/ohrms/DOCKETS/98fr/E6-1998.htm. Accessed 16 Sept 2011
6. Barrow P (2011) Developmental and reproductive toxicity testing of vaccines. J Pharmacol Toxicol Methods 65(2):58-63. doi: 10.1016/j. vascn.2011.12.001
7. ICH (2009) Draft consensus guideline. Addendum to ICH S6: preclinical safety evaluation of biotechnology-derived pharmaceuticals. http://www.ich.org/ fileadmin/Public-Web-Site/ICH-Products/Guidelines/Safety/S6- R1/Step4/S6-R1-Guideline.pdf. Accessed 16 Sept 2011
8. Pentsuk N, van der Laan JW (2009) An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol 86:328-344
9. Barrow PC, Barbellion S, Stadler J (2010) Preclinical evaluation of juvenile toxicity. In: Gautier J-C (ed) Drug safety evaluation: methods and protocols. Humana Press, New York, pp 17-38
10. House RV, Selgrade MJ (2010) A quarter-century of immunotoxicology: looking back, looking forward. Toxicol Sci 118:1-3
11. Dietert RR, DeWitt J (2010) Developmental immunotoxicity (DIT): the why, when and how of DIT testing. In: Dietert RR (ed) Immunotoxicity testing: methods and protocols. Humana Press, New York, pp 17-26
12. EMEA (1997) Note for guidance on preclini-cal pharmacological and toxicological testing of vaccines. CPMP/SWP/465/95. http://www.ema.europa.eu/ docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003102.pdf. Accessed 16 Sept 2011
13. ICH (2005) Harmonised tripartite guideline S5(R2). Detection of toxicity to reproduction for medicinal products & toxicity to male fertility. http://www.ich.org/fileadmin/Public-Web-Site/ICH-Products/Guidelines/Safety/ S5-R2/Step4/S5-R2-Guideline.pdf. Accessed 16 Sept 2011