Fed Bioequivalence Studies for Immediate Release Drug Products: Beneficial or Wastage.
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Date
2014-07
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Abstract
Aims: The present study was undertaken to understand the need of fed bioequivalence
studies for immediate release pharmaceutical products and thereby evaluating the relative
appropriateness of guidelines given by the European Medicines Agency (EMA) and the
United States Food and Drug Administration (USFDA). Vulnerability to show bioequivalent
or non-bioequivalent results on the basis of type of drugs was also assessed.
Study Design: The present work is a meta-analysis involving 162 bioequivalence studies
conducted on healthy human subjects.
Place and Duration of Study: Accutest Research Laboratories (I) Pvt Ltd, A-31, Khairne
MIDC, TTC Industrial Area, Khairne, Navi Mumbai, 400 709, India, between June 2013
and February 2014.
Methodology: The present meta-analysis included a total of 162 bioequivalence studies
of which 81 were conducted under fasted condition and the other 81 studies were
conducted under fed condition. The drug products were fixed dose combinations and
mono drug products for 22 and 140 studies respectively representing all the classes of
Biopharmaceutics Classification System (BCS). The bioequivalence was assessed by
standard criteria laid down by regulatory authorities. The results were correlated with the respective condition of study (fasted or fed) and the corresponding BCS class of the drug
product. The observations were discussed in the light of available literature.
Results: A total of 78 and 74 studies conducted under fasting and fed conditions
respectively had bioequivalent results. All studies conducted on fixed dose combination
products had bioequivalent results. Five drug products had bioequivalent results only
under fasting condition which proportionately contributed to 6.17% (5/81 fasting studies).
These drug products complied only with the EMA guidelines and not USFDA defined
passing criteria. All drug products belonging to BCS classes I and III showed
bioequivalent results whereas drug products belonging to BCS class IV contributed to
80% of the total non-bioequivalent studies.
Conclusion: The EMA approach can be followed for BCS class I drugs while USFDA
approach looks better for remaining drug products. Further research work is required to
confirm the trend observed in our meta-analysis.
Description
Keywords
Bioequivalence, immediate release products, solubility, permeability
Citation
Khandave Suhas S, Sawant Satish V, Deshmukh Trupti V, Shaikh Farhat M, Khandave Urmila S, Sahane Rakhi V. Fed Bioequivalence Studies for Immediate Release Drug Products: Beneficial or Wastage. British Journal of Pharmaceutical Research. 2014 July; 4(14): 1696-1706.