Search results for bioequivalence

Pharmacokinetics and relative bioavailability of sitagliptin hydrochloride and sitagliptin phosphate tablets formulations: a randomized, open-label, crossover study in healthy male volunteers

Author byline as per print journal: Chuei Wuei Leong1, PhD; Elton Sagim1, BBiomedSc, Kar Ming Yee1, BPharm; Muhammad Shalhadi Saharuddin1, BSc; Sharifah Radziah Syed Abd Rahim1, MSc; Khairil Sabri1, BSc; Mohd Zulhairi Jamaluddin1, BSc; Shahnun Ahmad1, MBBS; Atiqah Amran1, BSc; Rabab F Tayyem2, PhD Introduction/Study Objectives: The present study aimed to evaluate the comparative bioavailability […]

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Pharmacokinetic bioequivalence of sitagliptin phosphate tablet formulations: a randomized, open-label, crossover study in healthy volunteers

Author byline as per print journal: Chuei Wuei Leong1, PhD; Elton Sagim1, BBiomedSc; Kar Ming Yee1, BPharm; Muhammad Shalhadi Saharuddin1, BSc; Nik Mohd Zulhakimi Nik Abdullah1, BSc; Noramirah Farhanah Saberi1, BSc; Rajavikraman Boopathy1, DipSc; Shahnun Ahmad1, MBBS; Atiqah Amran1, BSc; Raman Batheja2, PhD; Rajan Sharma2>, MBBS; Kiran Kumar Vuppalavanchu2, MPharm Introduction/Study Objectives: The aim of […]

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Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers

Author byline as per print journal: Nishalini Harikrishnan1, BSc; Ka-Liong Tan2, DPhil; Kar Ming Yee3, BPharm; Alia Shaari Ahmad Shukri1, MSc; Nalla Ramana Reddy4, MBBS; Chuei Wuei Leong3, PhD Introduction/Study Objectives: A bioequivalence study was performed to compare the pharmacological profile of innovator etoricoxib (ETO) with a newly developed generic ETO, both in a 120 […]

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Adjusted indirect comparisons between generics – bioequivalence and interchangeability

Abstract: Adjusted indirect comparisons are valuable to establish the bioequivalence and thereby the interchangeability between generic drug products. Limitations should be observed especially when several generics of a drug are marketed. Submitted: 14 June 2016; Revised: 23 June 2016; Accepted: 24 June 2016; Published online first: 4 July 2016 A recent review discussed adjusted indirect […]

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Assessment of the interchangeability between generics

Author byline as per print journal: Luther Gwaza1,2, BPharm, MPhil; John Gordon3, PhD; Henrike Potthast4, PhD; Marc Maliepaard5, PhD; Jan Welink5, Hubert Leufkens1,5, PhD; Matthias Stahl6, MD; Alfredo García-Arieta7, PhD Abstract: Generic medicines are approved by regulatory authorities based on demonstration of bioequivalence with the innovator, however, direct comparison between all available generics of the […]

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Bioequivalence of narrow therapeutic index drugs and immunosuppressives

Author byline as per print journal: Christoph Baumgärtel, MD, MSc; Brian Godman, BSc, PhD Abstract: Stricter bioequivalence criteria are in place for generics where there are narrow therapeutic indexes such as generic immunosuppressives, enhancing their acceptance despite limited published studies. No serious issues have been reported to date with generic ciclosporin despite being on the market […]

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New product-specific bioequivalence guidance

Abstract: For harmonization of the authorization requirements for specific generic applications within the EU, consistent criteria were drafted for 16 active substances, which are out now for public consultation. Submitted: 2 January 2014; Revised: 6 January 2014; Accepted: 7 January 2014; Published online first: 20 January 2014 Official draft guidance has recently become available for […]

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Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil

Abstract: This position paper deals with our regulatory opinion on registered generic immunosuppressants such as ciclosporin, tacrolimus and mycophenolate mofetil, and provides arguments why these medicines are considered equally safe and effective as the branded drug based on demonstrated bioequivalence. Though regulators acknowledge the worries from the field, we are of the opinion that there […]

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Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

Author byline as per print journal: Professor Shein-Chung Chow, PhD, Christine Ju, MSc Abstract: Biological (large molecule) drug products are made via living systems and are complex and variable in nature. As a result, generic forms of biological products, also termed biosimilars in the EU or follow-on biologics by the US Food and Drug Administration, can […]

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Why bioequivalence and unconditional interchangeability of generic drugs are not the same

Abstract: The patents for a number of cornerstone immunosuppressive drugs used in the field of solid organ transplantation have expired. Generic formulations are now available and several professional societies and individual physicians have given their opinions on the issue of generics substitution. In this issue of GaBI Journal, several hot topics related to implementation of […]

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Myths, questions, facts about generic drugs in the EU

Abstract: Many generic drugs are now being prescribed and the trend is increasing. For example, in Austria, the number of all generics prescriptions has more than doubled from 11% in 2000 to 23% in 2010. However, many myths and questions about generic drugs remain and information may be difficult to come by. It is therefore […]

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Generic clopidogrel–the medicines agency’s perspective

Abstract:  A number of generic products containing clopidogrel as the active substance have been marketed in Austria and the EU for some time. Due to different clopidogrel salt preparations and different indications, doubts arose as to whether the products could be considered as equivalent. The Austrian Federal Office for Safety in Health Care (BASG)/The Austrian Agency for Health and Food Safety […]

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