Applying the Noninferiority Paradigm to Assess Exposure‐Response Similarity and Dose Between Pediatric and Adult Patients

The use of extrapolation of efficacy in pediatric drug development programs is possible when disease progression and treatment response are similar in adult and pediatric populations. Historically, the exposure‐response (E‐R) similarity was assessed by visual inspection of 2 E‐R curves to support pe...

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Veröffentlicht in:	Journal of clinical pharmacology 2021-06, Vol.61 (S1), p.S165-S174
Hauptverfasser:	Zhang, Qunshu, Travis, James, Rothwell, Rebecca, Jay, Christopher E., Jahidur, Rashid, Zhang, Yifei, Crentsil, Victor, Altepeter, Tara, Lee, Jessica J., Burckart, Gilbert J., Ganley, Charles, Wang, Jian
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Bayesian analysis Child Data Interpretation, Statistical Dose-Response Relationship, Drug Drug Approval - methods Drug development Drug Development - methods Drug Dosage Calculations exposure‐response extrapolation Humans Patients pediatric drug development Pediatrics Pediatrics - methods Probability regulatory science United States United States Food and Drug Administration
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