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

Yıl 2015, Cilt: 28 Sayı: 2, 90 - 93, 14.09.2015

Suheyla Toprak Selen Evirgen Hilal Ilbars

https://doi.org/10.5472/MMJoa.2802.05

Öz

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.

Keywords: Bioequivalence, Bioavailability, Clinical trials, Turkey

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