Fed Bioequivalence Studies for Immediate Release Drug Products: Beneficial or Wastage?

Journal Title: Journal of Pharmaceutical Research International - Year 2014, Vol 4, Issue 14

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.

Authors and Affiliations

Suhas S. Khandave, Satish V. Sawant, Trupti V. Deshmukh, Farhat M. Shaikh, Urmila S. Khandave, Rakhi V. Sahane

Keywords

Related Articles

Anti-Cancerous Efficacy of Alcoholic and Aqueous Extracts from an Endemic Plant Thermopsis turcica on Liver Carcinoma

Aims: Thermopsis turcica (T. turcica) is endemic to Turkey. Its general medicinal properties are obvious, but no investigations have been made in term of its anticancerous efficacy against liver carcinoma. So, the presen...

Pharmacological Effect of α-Glucosidase Inhibitor Voglibose in a Novel Obese Diabetic Model

Aim: This study was conducted to investigate the preventive or therapeutic effect of α-glucosidase inhibitor voglibose in a new model rat, Spontaneously Diabetic Torii-Leprfa (SDT fatty) rat, which is a novel type 2 diab...

Assessment of Quality of “Dhanyamla”: A Fermented Cereal Used in Ayurveda

Aim: Dhanyamla is a medicinal preparation having great therapeutic values which is described under the Sandhana Kalpana in Ayurveda texts. In the present study, an attempt was made to assess the quality of Dhanyamla by u...

In vitro Cytotoxicity of Scopoletin Derived from Eupatorium laevigatum Lam.

Aims: Eupatorium laevigatum Lam. is commonly used as anti-inflammatory, antiseptic, anti-rheumatic, and in the treatment of colds and ulcers. The present study aimed to characterize the active fractions of the aerial par...

Pharmacokinetic Characterization of Piperaquine in Nigerian Healthy Volunteers after Co-administration with a Commercial Brand of Moringa Tea

This 2-phase cross-over drug–herb interaction study investigated the effect of co-administration of tea prepared from the commercial product of Moringa oleifera on the pharmacokinetic parameters of piperaquine. Fourteen...

Download PDF file
  • EP ID EP344623
  • DOI 10.9734/BJPR/2014/10496
  • Views 65
  • Downloads 0

How To Cite

Suhas S. Khandave, Satish V. Sawant, Trupti V. Deshmukh, Farhat M. Shaikh, Urmila S. Khandave, Rakhi V. Sahane (2014). Fed Bioequivalence Studies for Immediate Release Drug Products: Beneficial or Wastage?. Journal of Pharmaceutical Research International, 4(14), 1696-1706. https://europub.co.uk/articles/-A-344623