The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action

Verbeeck, Roger K.; Musuamba, Flora T.

doi:10.18433/j3vc8j

Cited by 32 publications

(27 citation statements)

References 45 publications

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“…In this study, the 90% CIs for the GMRs (warfarin + lobeglitazone vs warfarin) of C max and AUC last for R - and S -warfarin were within the bioequivalence guidelines-specified comparability bounds of 0.80–1.25. The 90% CIs were also entirely within the tightened interval of 90.00%–111.11% for narrow therapeutic index drugs 22,23. In line with the lack of an effect on warfarin PK, concomitant administration of lobeglitazone had no effect on the PD of single-dose warfarin, which was assessed through the measurement of INR and factor VII.…”

Section: Discussionmentioning

confidence: 63%

Lack of the effect of lobeglitazone, a peroxisome proliferator-activated receptor-γ agonist, on the pharmacokinetics and pharmacodynamics of warfarin

Jung

Lee

Kim

et al. 2015

DDDT

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AimsLobeglitazone has been developed for the treatment of type 2 diabetes mellitus. This study was conducted to evaluate potential drug–drug interactions between lobeglitazone and warfarin, an anticoagulant with a narrow therapeutic index.MethodsIn this open-label, three-treatment, crossover study, 24 healthy male subjects were administered lobeglitazone (0.5 mg) for 1–12 days with warfarin (25 mg) on day 5 in one period. After a washout interval, subjects were administered warfarin (25 mg) alone in the other period. Pharmacokinetics of R- and S-warfarin and lobeglitazone, as well as pharmacodynamics of warfarin, as measured by international normalized ratio (INR) and factor VII activity, were assessed.ResultsThe geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for area under the curve from time zero to the time of the last quantifiable concentration (AUClast) for warfarin + lobeglitazone: warfarin alone were 1.0076 (90% CI: 0.9771, 1.0391) for R-warfarin and 0.9880 (90% CI: 0.9537, 1.0235) for S-warfarin. The maximum observed plasma concentration (Cmax) values were 1.0167 (90% CI: 0.9507, 1.0872) for R-warfarin and 1.0028 (90% CI: 0.9518, 1.0992) for S-warfarin, both of which were contained in the interval 0.80–1.25. Lobeglitazone had no effect on the area under the effect–time curve from time 0 to 168 hours (AUEC) of INR and factor VII activity, as demonstrated by the GMRs of 1.0091 (90% CI: 0.9872, 1.0314) and 0.9355 (90% CI: 0.9028, 0.9695), respectively. In addition, the pharmacokinetics of lobeglitazone was also unaffected by warfarin.ConclusionConcomitant administration of lobeglitazone and warfarin was well tolerated. Lobeglitazone had no meaningful effect on the pharmacokinetics or pharmacodynamics of warfarin. These findings indicate that lobeglitazone and warfarin can be coadministered without dosage adjustments for either drug.

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Section: Discussionmentioning

confidence: 63%

Lack of the effect of lobeglitazone, a peroxisome proliferator-activated receptor-γ agonist, on the pharmacokinetics and pharmacodynamics of warfarin

Jung

Lee

Kim

et al. 2015

DDDT

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“…Selection of only healthy volunteers in BA/BE studies registered in database in Turkey is in line with the recommendation that BA/BE studies should normally be performed with healthy volunteers to minimize variability and permit detection of differences between pharmaceutical products [5].…”

Section: Endpointmentioning

confidence: 87%

Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014

Toprak¹,

Evirgen²,

Ilbars³

2015

MMJ

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Objective: To evaluate bioavailability (BA) and bioequivalence (BE) studies conducted in Turkey between January 2008 and the end of June 2014.Materials and Methods: Data on BA/BE studies collected from databases for 2008-2014 studies of Turkish Medicines and Medical Devices Agency were evaluated in terms of endpoint classification (BA/BE), allocation status (randomized/nonrandomized), blinding (open/single blind/double blind), dose (single/multiple dose), and interventional group (single group/ parallel/cross-over/factorial). Results:All studies were open, randomized with healthy male volunteers, and the majority had a crossover design and a single dose. Overall, 670 studies were conducted in Turkey between January 2008 and June 2014, while BE (n=631, 94.2%) studies formed the major part. All studies conducted between 2008 and 2010 (n=274) were BE studies. Thirty-nine (5.8% of overall studies) BA studies were conducted from 2011 to 2014, including 13 studies in 2011 (33.3% of overall BA studies), 15 in 2012 (38.4% of overall BA studies), 6 in 2013 (15.4% of overall BA studies) and 5 in 2014 (12.8% of overall BA studies). Conclusions:Our findings showed that 670 BA/BE studies were conducted in Turkey between 2008 and 2014, including 631 BE and 39 BA studies with gradual increase in the number of both types of studies throughout the years.

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“…Therapeutically equivalent drug products are considered if they meet the regulatory criteria of pharmaceutical equivalence and bioequivalence [3][4][5][6][7] . For determination of therapeutic effectiveness, the aspects of safety, quality and purity has to be evaluated.…”

Section: Quick Response Codementioning

confidence: 99%

Untitled

2017

IJPSR

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ABSTRACT:Metronidazole is a class I drug in biopharmaceutics classification system (BCS) and widely used in Pakistan, various available brands in local markets along with innovator brand to serve a large population. In-vitro dissolution testing can be used as waiver for in-vivo bioequivalence studies of generic brand interchangeability for Class I drugs i.e., highly soluble and highly permeable. The objective of the study was to determine immediate release tablet dosage form of metronidazole to fulfil the requirements of 85% drug release in pH 1.2, 4.5 and 6.8 recommended by WHO. In this study physicochemical quality attributes, price comparison and dissolution studies were performed on three available brands of metronidazole 400 mg, one of them is innovator brand and the two others are test brands. The dissolution profiles were compared by using similarity factor (f 2 ) that were analyzed by UV spectrophotometer at 278 nm wavelength. The test brands were very cheap in cost as compared to innovator brand but both the test brand were failed the dissolution test in all mediums and only innovator brand showed 85% drug release within 30 minutes. The study suggested test brands are not equivalent or similar to innovator brand. In-vivo bioequivalence studies are thus needed for test brands to strengthen this invitro finding.

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The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action

Cited by 32 publications

References 45 publications

Lack of the effect of lobeglitazone, a peroxisome proliferator-activated receptor-γ agonist, on the pharmacokinetics and pharmacodynamics of warfarin

Lack of the effect of lobeglitazone, a peroxisome proliferator-activated receptor-γ agonist, on the pharmacokinetics and pharmacodynamics of warfarin

Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014

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The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action

Cited by 32 publications

References 45 publications

Lack of the effect of lobeglitazone, a peroxisome proliferator-activated receptor-&gamma; agonist, on the pharmacokinetics and pharmacodynamics of warfarin

Lack of the effect of lobeglitazone, a peroxisome proliferator-activated receptor-&gamma; agonist, on the pharmacokinetics and pharmacodynamics of warfarin

Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014

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Lack of the effect of lobeglitazone, a peroxisome proliferator-activated receptor-γ agonist, on the pharmacokinetics and pharmacodynamics of warfarin

Lack of the effect of lobeglitazone, a peroxisome proliferator-activated receptor-γ agonist, on the pharmacokinetics and pharmacodynamics of warfarin