Literature DB >> 24048239

Confidence in generic drug substitution.

R Lionberger1, W Jiang, S-M Huang, G Geba.   

Abstract

Patients should have confidence that the generic drugs they are prescribed in the United States can be effectively substituted for the brand product or another generic product. Through new bioequivalence study designs for narrow therapeutic index (NTI) drugs and postapproval studies of generic substitution, the US Food and Drug Administration's (FDA's) ongoing generic drug regulatory science activities are designed to ensure successful generic substitution for all drug products.

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Year:  2013        PMID: 24048239     DOI: 10.1038/clpt.2013.104

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  6 in total

1.  A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion.

Authors:  Wenlei Jiang; Fairouz Makhlouf; Donald J Schuirmann; Xinyuan Zhang; Nan Zheng; Dale Conner; Lawrence X Yu; Robert Lionberger
Journal:  AAPS J       Date:  2015-04-04       Impact factor: 4.009

Review 2.  How accurate and precise are limited sampling strategies in estimating exposure to mycophenolic acid in people with autoimmune disease?

Authors:  Azrin N Abd Rahman; Susan E Tett; Christine E Staatz
Journal:  Clin Pharmacokinet       Date:  2014-03       Impact factor: 6.447

3.  The adoption of generic immunosuppressant medications in kidney, liver, and heart transplantation among recipients in Colorado or nationally with Medicare part D.

Authors:  Qian Liu; Abigail R Smith; Jeong M Park; Murewa Oguntimein; Sarah Dutcher; Ghalib Bello; Margaret Helmuth; Marc Turenne; Rajesh Balkrishnan; Melissa Fava; Charlotte A Beil; Adam Saulles; Sangeeta Goel; Pratima Sharma; Alan Leichtman; Jarcy Zee
Journal:  Am J Transplant       Date:  2018-03-31       Impact factor: 8.086

Review 4.  Formulation predictive dissolution (fPD) testing to advance oral drug product development: An introduction to the US FDA funded '21st Century BA/BE' project.

Authors:  Bart Hens; Patrick D Sinko; Nicholas Job; Meagan Dean; Jozef Al-Gousous; Niloufar Salehi; Robert M Ziff; Yasuhiro Tsume; Marival Bermejo; Paulo Paixão; James G Brasseur; Alex Yu; Arjang Talattof; Gail Benninghoff; Peter Langguth; Hans Lennernäs; William L Hasler; Luca Marciani; Joseph Dickens; Kerby Shedden; Duxin Sun; Gregory E Amidon; Gordon L Amidon
Journal:  Int J Pharm       Date:  2018-06-23       Impact factor: 5.875

5.  Prescribing Generic Medication in Chronic Musculoskeletal Pain Patients: An Issue of Representations, Trust, and Experience in a Swiss Cohort.

Authors:  Valérie Piguet; Stéphanie D'Incau; Marie Besson; Jules Desmeules; Christine Cedraschi
Journal:  PLoS One       Date:  2015-08-03       Impact factor: 3.240

6.  Is it ethical to prescribe generic immunosuppressive drugs to renal transplant patients?

Authors:  Julie Allard; Marie-Chantal Fortin
Journal:  Can J Kidney Health Dis       Date:  2014-09-09
  6 in total

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