Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of Extrapolation

被引：27

作者：

Barrett, Jeffrey S. ^{[1
]}

Bishai, Raafat ^{[2
]}

Bucci-Rechtweg, Christina ^{[3
]}

Cheung, Amy ^{[4
]}

Corriol-Rohou, Solange ^{[5
]}

Haertter, Sebastian ^{[6
]}

James, Angela ^{[7
]}

Kovacs, Steven J. ^{[8
]}

Liu, Jing ^{[9
]}

Potempa, Dennis ^{[10
]}

Strougo, Ashley ^{[10
]}

Vanevski, Konstantina ^{[11
]}

机构：

[1] Sanofi, Translat Med, Translat Informat, Bridgewater, NJ USA

[2] AstraZeneca, Clin Dev, Dept Metab Dis, Gaithersburg, MD USA

[3] Novartis Pharmaceut, Global Hlth Policy, Regulatory Affairs, E Hanover, NJ USA

[4] AstraZeneca, Quantitat Clin Pharmacol, Early Clin Dev, Innovat Med & Early Dev Biotech Unit, Cambridge, England

[5] Astra Zeneca, GRAPSQA Global Med Dev, Paris, France

[6] Boehringer Ingelheim Pharma GmbH & Co KG, Translat Med & Clin Pharmacol, Ridgefield, CT USA

[7] Astellas Pharma, Clin Pharmacol & Exploratory Dept, Northbrook, IL USA

[8] Novartis Inst BioMed Res, Translat Med, E Hanover, NJ USA

[9] Pfizer, Clin Pharmacol, Groton, CT USA

[10] Sanofi, Translat Med Pharmacokinet Dynam & Metab, M&S, Frankfurt, Germany

[11] Bayer HealthCare, Global Clin Dev, Basel, Switzerland

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2018年 / 103卷 / 03期

关键词：

DRUG-DEVELOPMENT; CLINICAL-TRIAL; MYELOID-LEUKEMIA; CHILDREN; SIMULATION; CANCER; YOUTH; PHARMACOMETRICS; PHARMACOLOGY; ADOLESCENTS;

D O I：

10.1002/cpt.1000

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Extrapolation can be used to address challenges in pediatric drug development. This review describes how these challenges could be addressed by further evolution of quantitative frameworks (i.e., model-based/informed drug discovery and development) and regulatory science in support of pediatric drug development. Included are examples of diseases/indications where extrapolation has been used in different ways as a basis for identifying gaps in the framework and opportunities for continued advancement of pediatric drug development.

引用

页码：419 / 433

页数：15

共 84 条

[1] Improving the outcome for children with cancer: Development of targeted new agents [J].

Adamson, Peter C. .

CA-A CANCER JOURNAL FOR CLINICIANS, 2015, 65 (03) :212-220

[2]

[Anonymous], 2014, GUID IND AN IND DEV

[3]

[Anonymous], 2016, UPD ANT DRUG EFF AD

[4]

[Anonymous], 2017, PHARM SCI CLIN PHARM

[5]

[Anonymous], 2014, GUIDANCE IND GEN CLI

[6]

[Anonymous], 2016, GUID DEV NEW MED PRO

[7]

[Anonymous], 2016, The Journal of Pediatric Pharmacology and Therapeutics, V21, P98

[8]

[Anonymous], 2017, European Medicines Agency procedural advice for users of the centralised procedure for generic/hybrid applications

[9]

[Anonymous], 2017, INT C HARMONIZATION

[10] Effects of Metformin, Metformin Plus Rosiglitazone, and Metformin Plus Lifestyle on Insulin Sensitivity and β-cell Function in TODAY [J].

Arslanian, Silva ;

Pyle, Laura ;

Payan, Marisa ;

Bacha, Fida ;

Caprio, Sonia ;

Haymond, Morey W. ;

Levitsky, Lynne L. ;

Goland, Robin ;

White, Neil H. ;

Willi, Steven M. .

DIABETES CARE, 2013, 36 (06) :1749-1757

← 1 2 3 4 5 6 7 8 9 →