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.

• All(57)
• Posters(12)
• Presentations(15)
• Papers(30)

• Determination of CYP2D6 Phenotyping for Metoprolol using CYP2D6 Genotype-derived Activity Score: Results from a Prospective, Clinical Trial

  Thomas, C D; Monsely, S A; El Rouby, N; Kim, S; Lingineni, K; Langaee, T; Langaee, T; Gong, Y; Johnson, J A; Schmidit, S O; Fyre, R F; Cavallari, L H

• Assessing The Association Of Four Measurements Of Adherence To Tacrolimus For Organ Transplant Recipients

  Peipert, John; Waterman, Amy; Tsai, Eileen; Morisky, Donald; Zonana, Moses; Bunnapradist, Suphamai

• Evaluation of Clinical and Safety Outcomes Following Uncontrolled Tacrolimus Conversion in Adult Renal Transplant Recipients

  Lichvar, Alicia; Tremblay, Simon; Naik, Devanshi; Lipscomb, Jessi; King, Eileen; Vinks, Alexander; Christians, Uwe; Alloway, Rita

• Evaluation of Clinical and Safety Outcomes Following Uncontrolled Tacrolimus Conversion in Adult Renal Transplant Recipients

  Lichvar, Alicia; Tremblay, Simon; Naik, Devanshi; King, Eileen; Vinks, Alexander; Christians, Uwe; Alloway, Rita

• Bioequivalence Assessment of Brand and Generic Lamotrigine Extended-Release Tablets

  Li, Zhichuan; Zheng, Nan; Wen, Hong; Fang, Lanyan; Zhang, Xinyuan; Sun, Dajun; Kinjo, Minori; Zhao, Liang; Jiang, Wenlei; Lionberger, Robert

• 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

• 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

• 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

• 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

• TACROLIMUS PBPK MODELING USING REALISTIC PHYSIOLOGICAL FACTORS IN RENAL TRANSPLANT PATIENTS

  Emoto, Chie; Fukuda, Tsuyoshi; Hahn, D; Christians, Uwe; Alloway, Rita; Vinks, Alexander