Year 2015, Volume 28 , Issue 2, Pages 90 - 93 2015-09-14

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

Suheyla TOPRAK [1] , Selen EVİRGEN [2] , Hilal ILBARS [3]


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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Primary Language en
Journal Section Articles
Authors

Author: Suheyla TOPRAK

Author: Selen EVİRGEN

Author: Hilal ILBARS

Dates

Publication Date : September 14, 2015

Bibtex @ { marumj3177, journal = {Marmara Medical Journal}, issn = {1019-1941}, eissn = {1309-9469}, address = {}, publisher = {Marmara University}, year = {2015}, volume = {28}, pages = {90 - 93}, doi = {10.5472/MMJoa.2802.05}, title = {Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014}, key = {cite}, author = {Toprak, Suheyla and Evi̇rgen, Selen and Ilbars, Hilal} }
APA Toprak, S , Evi̇rgen, S , Ilbars, H . (2015). Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014 . Marmara Medical Journal , 28 (2) , 90-93 . DOI: 10.5472/MMJoa.2802.05
MLA Toprak, S , Evi̇rgen, S , Ilbars, H . "Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014" . Marmara Medical Journal 28 (2015 ): 90-93 <https://dergipark.org.tr/en/pub/marumj/issue/430/3177>
Chicago Toprak, S , Evi̇rgen, S , Ilbars, H . "Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014". Marmara Medical Journal 28 (2015 ): 90-93
RIS TY - JOUR T1 - Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014 AU - Suheyla Toprak , Selen Evi̇rgen , Hilal Ilbars Y1 - 2015 PY - 2015 N1 - doi: 10.5472/MMJoa.2802.05 DO - 10.5472/MMJoa.2802.05 T2 - Marmara Medical Journal JF - Journal JO - JOR SP - 90 EP - 93 VL - 28 IS - 2 SN - 1019-1941-1309-9469 M3 - doi: 10.5472/MMJoa.2802.05 UR - https://doi.org/10.5472/MMJoa.2802.05 Y2 - 2021 ER -
EndNote %0 Marmara Medical Journal Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014 %A Suheyla Toprak , Selen Evi̇rgen , Hilal Ilbars %T Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014 %D 2015 %J Marmara Medical Journal %P 1019-1941-1309-9469 %V 28 %N 2 %R doi: 10.5472/MMJoa.2802.05 %U 10.5472/MMJoa.2802.05
ISNAD Toprak, Suheyla , Evi̇rgen, Selen , Ilbars, Hilal . "Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014". Marmara Medical Journal 28 / 2 (September 2015): 90-93 . https://doi.org/10.5472/MMJoa.2802.05
AMA Toprak S , Evi̇rgen S , Ilbars H . Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014. Marmara Med J. 2015; 28(2): 90-93.
Vancouver Toprak S , Evi̇rgen S , Ilbars H . Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014. Marmara Medical Journal. 2015; 28(2): 90-93.
IEEE S. Toprak , S. Evi̇rgen and H. Ilbars , "Bioavailability and bioequivalence studies in Turkey: A status report from the national registry of studies between 2008-2014", Marmara Medical Journal, vol. 28, no. 2, pp. 90-93, Sep. 2015, doi:10.5472/MMJoa.2802.05