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Biologicals
- ICH Topic S6: Preclinical safety evaluation of biotechnology-derived pharmaceuticals
EMEA, July 1997
 size: 85 kB
- Guidance on similar biological medicinal products
EMEA, October 2005
size: 106 kB, EMEA Web server
- Additional literature
- Vargas HM, Bass AS, Breidenbach A, Feldman HS, Gintant GA, Harmer AR, Heath B, Hoffmann P, Lagrutta A, Leishman D, McMahon N, Mittelstadt S, Polonchuk L, Pugsley MK, Salata JJ, Valentin JP (2008) Scientific review and recommendations on preclinical cardiovascular safety evaluation of biologics. J Pharmacol Toxicol Methods 58: 72-76
 PubMed abstract.
- Coe Clough NE, Hauer PJ (2005) Using polyclonal and monoclonal antibodies in regulatory testing of biological products. ILAR J 46: 300-306
PubMed abstract.
- Hendriksen CF (2002) Refinement, reduction, and replacement of animal use for regulatory testing: current best scientific practices for the evaluation of safety and potency of biologicals. ILAR J 43 Suppl: S43-S48
PubMed abstract.
Endocrine modulating compounds (including Endocrine disruptors)
- Uterotrophic Bioassay
Critical review and evaluation of the uterotrophic bioassay
OECD, September 2002
 zipped PDF file, size: 1.346 kB
Detailed background review of the uterotrophic bioassay
Owens JW, Ashby J (2002) Critical review and evaluation of the uterotrophic bioassay for the identification of possible estrogen agonists and antagonists: in support of the validation of the OECD uterotrophic protocols for the laboratory rodent. Organisation for Economic Co-operation and Development. Crit Rev Toxicol 32: 445-520
Above link shows the PubMed abstract
Guidance document uterotrophic assay
OECD, July 2007
size: 331 kB, OECD Web server
Validation uterotrophic assay
OECD, August 2007
size: 1.23 MB, OECD Web server
- Fish Endocrine Screening Assay
OECD, Endocrine Disrupter Testing and Assessment
- Hershberger Assay
Revised guideline Hershberger test
OECD, November 2008
size: 203 kB, OECD Web server
Validation report Hershberger test
OECD, November 2008
size: 556 kB, OECD Web server
Peer review document from the Hershberger bioassay
OECD, November 2007
size: 251 kB, OECD Web server
- Endocrine disruption: a guidance document for histologic evaluation of endocrine and reproductive tests
OECD, May 2008
Part 1: Guideline for dissection and trimming of endocrine tissues
size: 391 kB, OECD Web server
Part 2: Male reproductive system (pp. 1-5)
size: 1.06 MB, OECD Web server
Part 2: Male reproductive system (pp. 6-10)
size: 4.97 MB, OECD Web server
Part 2: Male reproductive system (pp. 11-20)
size: 2.90 MB, OECD Web server
Part 2: Male reproductive system (pp. 21-24)
size: 4.46 MB, OECD Web server
Part 2: Male reproductive system (p. 25)
size: 5.53 MB, OECD Web server
Part 2: Male reproductive system (pp. 26-27)
size: 4.21 MB, OECD Web server
Part 2: Male reproductive system (pp. 28-30)
size: 448 kB, OECD Web server
Part 3: Female reproductive system (pp. 1-17)
size: 3.92 MB, OECD Web server
Part 3: Female reproductive system (pp. 18-27)
size: 3.07 MB, OECD Web server
Part 3: Female reproductive system (pp. 28-45)
size: 3.51 MB, OECD Web server
Part 4. Mammary gland
size: 582 kB, OECD Web server
Part 5. Preparation, reading and reporting of vaginal smears
size: 282 kB, OECD Web server
Part 6: Pituitary gland
size: 2.01 MB, OECD Web server
- Endocrine Disruptor Screening Program (EDSP)
EPA Website
- Additional literature
- Combes RD (2004) Peer review of validation studies: an assessment of the role of the OECD by reference to the validation of the uterotrophic assay for endocrine disruptors. Altern Lab Anim 32: 111-117
PubMed abstract.
- Clode SA (2006) Assessment of in vivo assays for endocrine disruption. Best Pract Res Clin Endocrinol Metab 20: 35-43
PubMed abstract.
- Gelbke HP, Kayser M, Poole A (2004) OECD test strategies and methods for endocrine disruptors. Toxicology 205: 17-25
PubMed abstract.
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