GDUFA Research Outcomes
Generic Substitution
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to considerations impacting substitution with generic products.
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Genetic Polymorphisms at The Pregane X Receptor and CYP3A5 Loci Influence the Pharmacokinetics of Tacrolimus in Renal Transplant Patients
Hahn, David; Emoto, Chie; Christians, Uwe; Alloway, Rita; Vinks, Alexander; Fukuda, Tsuyoshi
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Optimal Study Design To Evaluate The Clinical Response Of Extended Release Formulations Of Methylphenidate (Mph) In A Pediatric Population
Gomeni, Roberto; Bressolle-Gomeni, Francoise; Spencer, Thomas; Faraone, Stephen
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Use of a clinical response index derived from a PK/PD model to estimate the optimal in vivo release rate of extended release formulations of MPH
Gomeni, Roberto; Bressolle-Gomeni, Francoise; Spencer, Thomas; Faraone, Stephen
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Meta-analytic Approach to Evaluate Alternative Models for Characterizing the PK Profiles of Extended Release Formulations of MPH
Gomeni, Roberto; Bressolle-Gomeni, Francoise; Spencer, Thomas; Faraone, Stephen
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TACROLIMUS PBPK MODELING USING REALISTIC PHYSIOLOGICAL FACTORS IN RENAL TRANSPLANT PATIENTS
Emoto, Chie; Fukuda, Tsuyoshi; Hahn, D; Christians, Uwe; Alloway, Rita; Vinks, Alexander
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Frequency Of Generic Brittleness In Epilepsy Patients
Das, Sharmila; Tung, Renee; Ting, Tricia; Polli, James
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Bioequivalence Analysis of Lamotrigine Extended-Release (ER) Tablets based on an In Vitro-In Vivo Relationship (IVIVR) Using the Physiologically Based Pharmacokinetic (PBPK) Absorption Model
Chow, Edwin; Zheng, Nan; Qu, Wen; Sun, Dajun; Wen, Hong; Zhang, Xinyuan; Jiang, Wenlei; Zhao, Liang