Pediatric Extrapolation in Type 2 Diabetes: Future Implications of a Workshop

被引：9

作者：

Barrett, Jeffrey S. ^{[1
]}

Bucci-Rechtweg, Christina ^{[2
]}

Amy Cheung, S. Y. ^{[3
]}

Gamalo-Siebers, Margaret ^{[4
]}

Haertter, Sebastian ^{[5
]}

Karres, Janina ^{[6
]}

Marquard, Jan ^{[7
]}

Mulugeta, Yeruk ^{[8
]}

Ollivier, Cecile ^{[9
]}

Strougo, Ashley ^{[10
]}

Yanoff, Lisa ^{[11
]}

Yao, Lynne ^{[8
]}

Zeitler, Philip ^{[12
]}

机构：

[1] Bill & Melinda Gates Med Res Inst, Quantitat Sci, Cambridge, MA USA

[2] Novartis Pharmaceut, Pediat & Maternal Hlth Policy, Regulatory Affairs, E Hanover, NJ USA

[3] Certara, Princeton, NJ USA

[4] Eli Lilly & Co, Global Stat Sci, Indianapolis, IN 46285 USA

[5] Boehringer Ingelheim GmbH & Co KG, Translat Med & Clin Pharmacol, Biberach, Germany

[6] European Med Agcy, Paediat Med Off, Amsterdam, Netherlands

[7] Boehringer Ingelheim GmbH & Co KG, Global Clin Dev CardioMetab, Ingelheim, Germany

[8] Ctr Drug Evaluat & Res, Off New Drugs, Div Pediat & Maternal Hlth, Washington, DC USA

[9] Aparito, Leiden, Netherlands

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

[11] Ctr Drug Evaluat & Res, Off New Drugs, Div Metab & Endocrinol Prod, Washington, DC USA

[12] Univ Colorado, Sch Med, Dept Pediat, Aurora, CO USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2020年 / 108卷 / 01期

关键词：

INSULIN-RESISTANCE; GLUCOSE-TOLERANCE; GLYCEMIC CONTROL; CLINICAL-TRIAL; YOUTH; ADOLESCENTS; PHARMACOKINETICS; CHILDREN; PHARMACODYNAMICS; CHALLENGES;

D O I：

10.1002/cpt.1805

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Extrapolation from adults to youth with type 2 diabetes (T2D) is challenged by differences in disease progression and manifestation. This manuscript presents the results of a mock-team workshop focused on examining the typical team-based decision process used to propose a pediatric development plan for T2D addressing the viability of extrapolation. The workshop was held at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) in Orlando, Florida on March 21, 2018.

引用

页码：29 / 39

页数：11

共 50 条

[1] Clinical Pharmacokinetics and Pharmacodynamics of Antihyperglycemic Medications in Children and Adolescents with Type 2 Diabetes Mellitus [J].

Akhlaghi, Fatemeh ;

Matson, Kelly L. ;

Mohammadpour, Amir Hooshang ;

Kelly, Meghan ;

Karimani, Asieh .

CLINICAL PHARMACOKINETICS, 2017, 56 (06) :561-571

[2]

[Anonymous], 1998, Guidance for Industry-Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products

[3]

[Anonymous], 2018, GUID CLIN INV MED PR

[4] Metabolic Contrasts Between Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes: II. Observations Using the Oral Glucose Tolerance Test [J].

Arslanian, Silva A. ;

Kahn, Steven E. ;

Buchanan, Thomas A. ;

Edelstein, Sharon L. ;

Ehrmann, David A. ;

Nadeau, Kristen J. ;

Palmer, Jerry P. ;

Utzschneider, Kristina M. .

DIABETES CARE, 2018, 41 (08) :1707-1716

[5]

AstraZeneca, STUD EV SAF EFF DAP

[6] In Vivo Insulin Sensitivity and Secretion in Obese Youth What are the differences between normal glucose tolerance, impaired glucose tolerance, and type 2 diabetes? [J].

Bacha, Fida ;

Gungor, Neslihan ;

Lee, SoJung ;

Arslanian, Silva A. .

DIABETES CARE, 2009, 32 (01) :100-105

[7] Population Pharmacokinetics and Exposure-Response (Efficacy and Safety/Tolerability) of Empagliflozin in Patients with Type 2 Diabetes [J].

Baron, Kyle T. ;

Macha, Sreeraj ;

Broedl, Uli C. ;

Nock, Valerie ;

Retlich, Silke ;

Riggs, Matthew .

DIABETES THERAPY, 2016, 7 (03) :455-471

[8] Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of Extrapolation [J].

Barrett, Jeffrey S. ;

Bishai, Raafat ;

Bucci-Rechtweg, Christina ;

Cheung, Amy ;

Corriol-Rohou, Solange ;

Haertter, Sebastian ;

James, Angela ;

Kovacs, Steven J. ;

Liu, Jing ;

Potempa, Dennis ;

Strougo, Ashley ;

Vanevski, Konstantina .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2018, 103 (03) :419-433

[9]

Boehringer Ingelheim, DIAB STUD LIN EMP CH

[10] Relationship Between Parental Diabetes and Presentation of Metabolic and Glycemic Function in Youth With Type 2 Diabetes: Baseline Findings From the TODAY Trial [J].

Chernausek, Steven D. ;

Arslanian, Silva ;

Caprio, Sonia ;

Copeland, Kenneth C. ;

El Ghormli, Laure ;

Kelsey, Megan M. ;

Koontz, Michaela B. ;

Orsi, Carisse M. ;

Wilfley, Denise .

DIABETES CARE, 2016, 39 (01) :110-117

← 1 2 3 4 5 →