Extrapolation as a Default Strategy in Pediatric Drug Development.

Gamalo, Margaret; Bucci-Rechtweg, Christina; Nelson, Robert M; Vanh, Linh; Porcalla, Ariel; Thackray, Helen; Cooner, Freda; Cutler, Lauren; Friend, Danielle; Portman, Ron

Gamalo, Margaret; Bucci-Rechtweg, Christina; Nelson, Robert M; Vanh, Linh; Porcalla, Ariel; Thackray, Helen; Cooner, Freda; Cutler, Lauren; Friend, Danielle; Portman, Ron.

Afiliação

Gamalo M; Global Biometrics and Data Management - GPD I&I Statistics, 500 Arcola Rd, Collegeville, PA, 19426, USA. margaret.gamalo@pfizer.com.
Bucci-Rechtweg C; Global Head for Pediatric and Maternal Health Policy, Novartis Pharmaceuticals, 1 Health Plaza, East Hanover, NJ, 07936, USA.
Nelson RM; Pediatric Drug Development, Johnson & Johnson, 1400 McKean Rd, Lower Gwynedd Township, Spring House, PA, 19002, USA.
Vanh L; Biostatistical Science and Pharmacometrics, Novartis Pharmaceutical, 250 Massachusetts Ave, Cambridge, MA, 02139, USA.
Porcalla A; Pharmacovigilance and Patient Safety, AbbVie, Inc, Bldg 51-2nd floor, 1 North Waukegan Road, North Chicago, IL, 60064, USA.
Thackray H; BioCryst Pharmaceuticals, 4505 Emperor Blvd., Suite 200., Durham, NC, 27703, USA.
Cooner F; Global Biostatistical Science, 1 Amgen Center Dr, Thousand Oaks, CA, 91320, USA.
Cutler L; Regulatory Affairs, Seagen, 30th Drive S.E., Bothell, WA, 98021, USA.
Friend D; Science and Regulatory Policy, Biotechnology Innovation Organization, 1201 Maryland Ave SW, Washington, DC, 20024, USA.
Portman R; Pediatric Therapeutic Area, Novartis Pharmaceutical, 250 Massachusetts Ave, Cambridge, MA, 02139, USA.

Ther Innov Regul Sci ; 56(6): 883-894, 2022 11.

Article em En | MEDLINE | ID: mdl-35006587

Assuntos

Desenvolvimento de Medicamentos; Adolescente; Criança; Humanos; Pediatria

Palavras-chave

Extrapolation; Pediatric drug development; Pediatric regulations; Treatment landscape archetypes

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Desenvolvimento de Medicamentos Tipo de estudo: Prognostic_studies Limite: Adolescent / Child / Humans Idioma: En Revista: Ther Innov Regul Sci Ano de publicação: 2022 Tipo de documento: Article País de afiliação: Estados Unidos

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