The backlash against bioequivalence and the interchangeability of brand-name and generic drugs
- The BCS, BDDCS, and Regulatory Guidances. Chen, Mei-Ling; Amidon, Gordon; Benet, Leslie; Lennernas, Hans; Yu, Lawrence // Pharmaceutical Research;Jul2011, Vol. 28 Issue 7, p1774
No abstract available.
- Retrospective evaluation of the dose equivalence of Botox and Dysport in the management of blepharospasm and hemifacial spasm: a novel paradigm for a never ending story. Bentivoglio, Anna; Ialongo, Tàmara; Bove, Francesco; Nigris, Francesca; Fasano, Alfonso // Neurological Sciences;Apr2012, Vol. 33 Issue 2, p261
Botox and Dysport are the preparations of botulinum neurotoxin most widely used for therapeutic purposes. Several studies have addressed the topic of the equivalency ratio (D/B ratio) to be used in clinical practice and whether a reliable value exists is still a matter of debate. To this...
- Pharmacovigilance in Public Health Programmes. // Drug Safety;2011, Vol. 34 Issue 10, p932
The article presents several abstracts related to drug safety including "Analysis of Characteristics About Drug Adverse Events Reports Received in KFDA During 2008-2010," by J. Ha, Y. Kim and M. Chung, "Tamoxifen-Duloxetine: Risk of Reduced Therapeutic Response of Tamoxifen," by J. Mahe and...
- Evaluation of the Bioequivalence and Pharmacokinetics of Two Tablet Formulations of Isosorbide-5-mono-nitrate after Single Oral Administration in Healthy Volunteers. Niopas, Ioannis; Daftsios, Athanasios C.; Nikolaidis, Nicolaos // Drug Research / Arzneimittel-Forschung;Mar2002, Vol. 52 Issue 3, p182
Presents a study to compare the pharmacokinetic parameters of two oral formulations of isosorbide-5-mononitrate. Methods; Results; Conclusion that the test and reference isosorbide-5-mononitrate formulations are bioequivalent.
- Randomised Crossover Studies of the Bioequivalence of Two Fenofibrate Formulations after Administration of a Single Oral Dose in Healthy Volunteers. Sonet, Bernard; Vanderbist, Francis; Streel, Bruno; Houin, Georges // Drug Research / Arzneimittel-Forschung;Mar2002, Vol. 52 Issue 3, p200
Presents a study to investigate the bioequivalence of a semi-solid formulation of fenofibrate, and a reference, micronized formulation of fenofibrate. Methods; Results; Conclusion that the two formulations are bioequivalent when administered at the doses studied.
- Individual Bioequivalence Revisited. Chen, M-L.; Lesko, L.J. // Clinical Pharmacokinetics;Oct2001, Vol. 40 Issue 10, p701
For decades, the establishment of bioequivalence has generally relied on the comparison of population averages between the test and reference formulations. In the early 1990s, individual bioequivalence was proposed to ensure that an individual could be switched from the reference product to the...
- Multiple-Dose Studies can be a More Sensitive Assessment for Bioequivalence than Single-Dose Studies: The Case with Omeprazole. Elkoshi, Z.; Behr, D.; Mirimsky, A.; Tsvetkov, I.; Danon, A. // Clinical Drug Investigation;2002, Vol. 22 Issue 9, p585
Objective: To evaluate the bioequivalence of two enteric-coated formulations of omeprazole, Losec (reference) and Omepradex (test). It is hypothesised that formulation differences may be accentuated following multiple-dose administration, and that testing after multiple administration may...
- Ambroxol Lozenge Bioavailability: An Open-Label, Two-Way Crossover Study of the Comparative Bioavailability of Ambroxol Lozenges and Commercial Tablets in Healthy Thai Volunteers. Rojpibulstit, Malee; Kasiwong, Srirat; Juthong, Siwasak; Phadoongsombat, Narubodee; Faroongsarng, Damrongsak // Clinical Drug Investigation;2003, Vol. 23 Issue 4, p273
Objective: To compare the bioavailability of two 15mg ambroxol lozenges with a commercial 30mg ambroxol tablet. Design: Open-label, two-way crossover study. Method: Each formulation was randomly administered to 20 healthy Thai volunteers (ten male and ten female) with a 1-week washout period...
- bioequivalent. // Taber's Cyclopedic Medical Dictionary (2009);2009, Issue 21, p264
A definition of the term "bioequivalent," which refers to being biologically equivalent to another agent or a drug whose physiological effects are indistinguishable from the effects of another, is presented.