Orphan drug development is not taking off
- PMID: 19552743
- PMCID: PMC2686065
- DOI: 10.1111/j.1365-2125.2009.03369.x
Orphan drug development is not taking off
References
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- Schieppati A, Henter J-I, Daina E, Aperia A. Why rare diseases are an important medical and social issue. Lancet. 2008;371:2039–41. - PubMed
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- Remuzzi G, Garattini S. Rare diseases: what's next? Lancet. 2008;371:1978–9. - PubMed
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- Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. Official Journal of the European Communities. L18:1–5. 22.01.2000.
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- Committee for Proprietary Medicinal Products. Note for Guidance on Repeated Dose Toxicity. [accessed 21 March 2008]. July 2000. Available at http://www.emea.europa.eu/pdfs/human/swp/104299en.pdf.
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- Committee for Proprietary Medicinal Products. Note for guidance on duration of chronic toxicity testing in animals (rodent and non rodent toxicity testing) [accessed 26 November 2008]. May 1999. Available at http://www.emea.europa.eu/pdfs/human/ich/030095en.pdf.
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