共 10 条
[1]
CHMP Guideline on the need for Non-Clinical Testing inJuvenile Animals on Human Pharmaceuticals for Paediatric Indicat-ions. EMEA. (EMEA/CHMP/SWP/169215/2005) . 2011
[2]
Preponderance of thiopurine S-methyltransferase deficiency and heterozygosity among patients intolerant to mercaptopurine or azathioprine. Evans WE,Hon YY,Bomgaars L,et al. Journal of Clinical Oncology . 2001
[3]
Pharmacoepidemiol. Evans S J,Waller P C,Davis S. Drug Safety . 2001
[4]
ICH S5(R2)Note for Guidance on the Detection of Toxicityto Reproduction for Medicinal Products&Toxicity to Male Fertility. ICH. (CPMP/ICH/386/95) . 2011
[5]
Guideline on Clinical Trials in Small Populations. EMEA EWP. (CHMP/EWP/83561/2005) . 2011
[6]
ICH E2C(R1)Note for Guidance on Clinical Safety DataManagement:Periodic Safety Update Reports for Marketed Drugs andAddendum. ICH. (CPMP/ICH/288/95) . 2011
[7]
ICH E11 Note for Guidance on the Clinical Investigation ofMedicinal Products in the Paediatric Population. ICH. (CPMP/ICH/2711/99) . 2010
[8]
CHMP guideline on conduct of pharmacovigilance formedicines used by the pediatric population. EMEA. (EMEA/CHMP/PhVWP/235910/2005-rev.1) . 2011
[9]
EMEA CHMP Guideline on Risk Assessment of Medicinal Prod-ucts on Human Reproduction andLactation:from Data to Labelling(EMEA/CHMP/203927/2005). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_gui-deline/2009/09/WC500002926.pdf . 2010
[10]
EMEA CHMP Guideline on Risk Management System for Medic-inal Products for Human Use(EMEA/CHMP/96268/2005). http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004888.pdf . 2011