Bioequivalence Study of Two Formulations of Escitalopram Oxalate 20 mg Tablets in Healthy Volunteers

Ocampo, Enrique Munoz Daniel; Yepes, Natalia

doi:10.4172/jbb.1000241

J Bioequiv Availab

2015

DOI: 10.4172/jbb.1000241

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Bioequivalence Study of Two Formulations of Escitalopram Oxalate 20 mg Tablets in Healthy Volunteers

Enrique Munoz Daniel Ocampo¹,

Natalia Yepes²

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2016

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Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution

Kaushal¹,

Singh²,

Gulati³

et al. 2016

J App Pharm Sci

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In the last one decade, due to expiry of patented products as well as their exclusivity period, a drastic decline of branded pharmaceutical products and up streaming of generic drug market has been observed in developed as well as developing nations. This up rise in generic drug market is expected to rise in future till the arrival of new brand in market. This prevailing conditions could result in proliferation of generic drug manufacturing companies. The fact that generics do not undergo thorough extensive trials like innovator drugs, fuels further fears regarding their inferiority. Moreover, due to the hard competition amongst various companies to market their generics, the frequency of fraud and corruption have embarked doubts in consumers mind to reality. In order to blow away the doubts and re-establishing the credibility of generics in market, bioequivalence (BE) guidelines with stricter regulation should be the demand. The present study highlights the relevant regulatory guidelines for the conduct of bioequivalence studies in US, Europe, Canada, India, South Africa and South East Asian Nations. A comparative study of the differences in study design and specifications have also been addressed.

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Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution

Kaushal¹,

Singh²,

Gulati³

et al. 2016

J App Pharm Sci

View full text Add to dashboard Cite

show abstract

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Bioequivalence Study of Two Formulations of Escitalopram Oxalate 20 mg Tablets in Healthy Volunteers

Cited by 1 publication

References 5 publications

Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution

Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution

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