Warning: Undefined array key "mm" in /www/wwwroot/www.ai-bt.com/si.php on line 10 Deprecated: trim(): Passing null to parameter #1 ($string) of type string is deprecated in /www/wwwroot/www.ai-bt.com/si.php on line 10 Withdrawal of generic budeprion for nonbioequivalence.

Literature DB >> 23216549

Withdrawal of generic budeprion for nonbioequivalence.

Janet Woodcock¹, Mansoor Khan, Lawrence X Yu.

Abstract

Mesh：

Substances：
Drugs, Generic
Bupropion

Year: 2012 PMID： 23216549 DOI： 10.1056/NEJMp1212969

Source DB: PubMed Journal: N Engl J Med ISSN： 0028-4793 Impact factor: 91.245

Keyword Cloud
Cited

× No keyword cloud information.

19 in total

Review 1. The risks of risk aversion in drug regulation.

Authors: Hans-Georg Eichler; Brigitte Bloechl-Daum; Daniel Brasseur; Alasdair Breckenridge; Hubert Leufkens; June Raine; Tomas Salmonson; Christian K Schneider; Guido Rasi
Journal: Nat Rev Drug Discov Date: 2013-11-15 Impact factor: 84.694

2. Metabolism of bupropion by carbonyl reductases in liver and intestine.

Authors: Jamie N Connarn; Xinyuan Zhang; Andrew Babiskin; Duxin Sun
Journal: Drug Metab Dispos Date: 2015-04-22 Impact factor: 3.922

3. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

Authors: Aaron S Kesselheim; Joshua J Gagne
Journal: Drug Saf Date: 2015-10 Impact factor: 5.606

4. Misidentification of Bupropion Glucuronide Metabolites and Re-evaluation of Metabolite Pharmacokinetics.

Authors: Aaron M Teitelbaum; Evan D Kharasch
Journal: Drug Metab Dispos Date: 2016-11 Impact factor: 3.922

Review 5. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.

Authors: Aaron S Kesselheim; Jennifer M Polinski; Lisa A Fulchino; Danielle L Isaman; Joshua J Gagne
Journal: Drugs Date: 2015-04 Impact factor: 9.546

Review 6. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 3. Pharmacological Treatments.

Authors: Sidney H Kennedy; Raymond W Lam; Roger S McIntyre; S Valérie Tourjman; Venkat Bhat; Pierre Blier; Mehrul Hasnain; Fabrice Jollant; Anthony J Levitt; Glenda M MacQueen; Shane J McInerney; Diane McIntosh; Roumen V Milev; Daniel J Müller; Sagar V Parikh; Norma L Pearson; Arun V Ravindran; Rudolf Uher
Journal: Can J Psychiatry Date: 2016-08-02 Impact factor: 4.356

Withdrawal of generic budeprion for nonbioequivalence.

Review 1. The risks of risk aversion in drug regulation.

2. Metabolism of bupropion by carbonyl reductases in liver and intestine.

3. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

4. Misidentification of Bupropion Glucuronide Metabolites and Re-evaluation of Metabolite Pharmacokinetics.

Review 5. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.

Review 6. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 3. Pharmacological Treatments.

7. Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence.

Review 8. Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges.

9. Identification and Structural Characterization of Three New Metabolites of Bupropion in Humans.

Review 10. Generic drugs for hypertension: are they really equivalent?