儿科人群药物临床试验技术指导原则2015(4)

2021-09-24 15:14

ICH: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use,人用药品注册技术规范国际协调会

PK: Pharmacokinetics,药代动力学

PD: Pharmacodynamics,药效学

参考文献

[1] Clinical Investigation of Medicinal Products in the Pediatric Population, ICH E11, 2000年7月发布.

[2] E11(R1): Clinical Investigation of Medicinal Products in the Pediatric Population, 2014年8月发布.

[3] Guidance for Industry and Review Staff-Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling (Draft), FDA, 2013年2月发布.

[4] Guidance for Industry-General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (Draft), FDA, 1998年11月发布.

[5] Guidance for Industry-Pediatric Study Plans: Content of and Process for Submitting

Initial Pediatric Study Plans and Amended Pediatric Study Plans (Draft), FDA, 2013年7月发布.

[6] General Considerations for the Clinical Evaluation Drugs in Infants and Children, FDA, 1977年9月发布.

[7] Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations, American Academy of Pediatrics, 2010年3月发布.

[8] Concept paper on extrapolation of efficacy and safety in medicine development, EMA, 2013年3月发布.

[9] Guideline on Pharmaceutical Development of Medicines 5 for Paediatric Use (Draft), EMA, 2013年1月发布.

[10] Guideline on Clinical Trials in Small Populations, EMA, 2007年2月发布.

[11] Guideline on Conduct of Pharmacovigilance for Medicines Used by the Paediatric Population, EMA, 2007年1月发布.

[12] Guideline on the Role of Pharmacokinetics in the Development of Medicinal Products in the Paediatric Population, EMA, 2007年1月发布.

[13] Julia Dunne, William J. Rodriguez, M. Dianne Murphy, et al. Extrapolation of Adult Data and Other Data in Pediatric Drug-Development Programs, Pediatrics, 2011, e1242-e1249.

[14] EfthymiosManolis, Cerard Pons, Proposals for Model-based Paediatric Medicinal Development within the Current European Union Regulatory Framework, British Journal of Clinical Pharmacology, 2009,68(4): 493-501.

[15] 儿科人群药代动力学研究技术指导原则(征求意见稿), CFDA-CDE, 2013年12

月25日发布.

[16] 儿科学(第8版), 人民卫生出版社, 2013年.

[17] 中华人民共和国民法通则, 1986年4月12日发布.


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