Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development

Sebastian Haertter

Sebastian Haertter, sebastian.haertter@boehringer-ingelheim.com, is clinical pharmacology expert (director) translational medicine and clinical pharmacology, Boehringer Ingelheim.

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S. Y. Amy Cheung

S. Y. Amy Cheung is senior director, Certara.

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Angela James

Angela James is director, Astellas Pharma Global Development.

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Ashley Strougo

Ashley Strougo is head of M&S Germany,pharmacokinetics, dynamics and metabolism, translational medicine, Sanofi.

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Christina Bucci-Rechtweg

Christina Bucci-Rechtweg is global head, pediatric and maternal health policy, Novartis Pharmaceuticals Corporation.

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Jing Liu

Jing Liu is senior director, clinical pharmacology, Pfizer.

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Meina Tao Tang

Meina Tao Tang is principal scientist, clinical pharmacology, Genentech, Inc.

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Paulien Ravenstijn

Paulien Ravenstijn is senior consultant, qPharmetra LLC.

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Satyendra Suryawanshi

Satyendra Suryawanshi is director, clinical pharmacology and pharmacometrics, Bristol Myers Squibb.

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Solange Corriol-Rohou

Solange Corriol-Rohou is senior regulatory affairs and policy director for Europe, CMO office and chair of AZ Paediatric Work Group Regulatory Excellence, AstraZeneca.

BioPharm International, BioPharm International-03-15-2021, Volume 2021 eBook, Issue 1
Pages: 31-35

Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.

Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.

Read this article in BioPharm International's Regulatory Sourcebook March 2021 eBook.

About the authors

Sebastian Haertter*, sebastian.haertter@boehringer-ingelheim.com, is clinical pharmacology expert (director) translational medicine and clinical pharmacology, Boehringer Ingelheim; S. Y. Amy Cheung is senior director, Certara; Angela James is director, Astellas Pharma Global Development;Ashley Strougo is head of M&S Germany,pharmacokinetics, dynamics and metabolism, translational medicine, Sanofi; Christina Bucci-Rechtweg is global head, pediatric and maternal health policy, Novartis Pharmaceuticals Corporation; Jing Liu is senior director, clinical pharmacology, Pfizer; Meina Tao Tang is principal scientist, clinical pharmacology,Genentech, Inc.; Paulien Ravenstijn is senior consultant, qPharmetra LLC; Raafat Bishai is global clinical program lead, AstraZeneca; Satyendra Suryawanshi is director, clinical pharmacology and pharmacometrics, Bristol Myers Squibb; and Solange Corriol-Rohou is senior regulatory affairs and policy director for Europe, CMO office and chair of AZ Paediatric Work Group Regulatory Excellence, AstraZeneca; all authors are members of the IQ Consortium.

*To whom all correspondence should be addressed.

Article Details

BioPharm International
eBook: Regulatory Sourcebook, March 2021
March 2021
Pages: 31–35

Citation

When referring to this article, please cite it as Sebastian Haertter et al., “Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development," BioPharm International Regulatory Sourcebook eBook (March 2021).