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Published on 25 April 2022

Structural characterization methods for biosimilars: fit-for-purpose, qualified or validated

Abstract: Detailed and accurate structural characterization of biopharmaceuticals is of paramount importance for product definition, assessment of impurities and achieving in-depth understanding of manufacturing processes. But how can we have...

Author(s): Richard L Easton, BSC (Hons), DIC, PhD

analytical development, mass spectrometry, process related impurities, structural characterization

DOI: 10.5639/gabij.2022.1101.007

3.326 views

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Editor's Letter

Published on 27 September 2017

Latest features in GaBI Journal, 2017, Issue 3

It is clear that greater use of generics and biosimilars could greatly decrease healthcare costs and thereby increase availability of important medicines. It is equally clear that these potential savings...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0603.020

3.262 views

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Published on 22 October 2014

2012/3-4 GaBI Journal Table of Contents

Contents Editor's Letter Latest features in GaBI Journal, 2012, issue 3-4 Letters to the Editor A bioethicist’s view of the use of biosimilars A clinician’s view of the ethics of...

3.256 views

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Published on 16 April 2015

2015/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the fourth volume of GaBI Journal Editorial Biosimilars: patient and physician acceptability is the fifth hurdle to market competition Letters...

3.253 views

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Original Research

Published on 24 November 2022

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,...

bioequivalence, new branded generics, pharmacokinetics, sitagliptin

DOI: 10.5639/gabij.2023.1201.003

3.229 views

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Published on 22 October 2014

2012/2 GaBI Journal Table of Contents

Contents Editor's Letter What to look forward to in GaBI Journal, 2012, issue 2 Editorial Equal protection under the law: Children and the Best Pharmaceuticals for Children Act Regulatory Tighter...

3.208 views

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Published on 19 June 2015

2015/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2015, Issue 2 Commentary Pro-generics policies and the backlog in medicines registration in South Africa: implications for access to essential and affordable medicines Original...

3.179 views

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Editor's Letter

Published on 04 May 2016

Editor’s introduction to the initial issue of the fifth volume of GaBI Journal

This issue begins with a Letter to the Editor by Professor Fabio V Teixeira from the Brazilian Inflammatory Bowel Disease (IBD) Society that deals basically with the issue of extrapolation...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0501.001

3.170 views

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Published on 22 October 2014

2014/2 GaBI Journal Table of Contents

Contents Editor's Letter What to look forward to in GaBI Journal, 2014, Issue 2 Editorial Complex molecules – current developments Commentary Defining and characterizing nonbiological complex drugs (NBCDs) – Is...

3.169 views

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Editor's Letter

Published on 08 March 2017

Editor’s introduction to the initial issue of the sixth volume of GaBI Journal

This first issue of 2017 includes a range of manuscripts of interest to readers. A Letter to the Editor from Professor Mohamed Izham Mohamed Ibrahim and Nada Moustafa Abdel Rida...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2017.0601.001

3.146 views

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Editor's Letter

Published on 26 October 2016

Latest features in GaBI Journal, 2016, Issue 3

The informed, appropriate use of follow-on pharmacological agents can provide significant cost savings for patients and payers. These savings can then be used by governments and patients to increase access...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0503.025

3.145 views

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Editor's Letter

Published on 27 August 2018

What to look forward to in GaBI Journal, 2018, Issue 2

The second issue of the 2018 GaBI Journal volume is being published at a time of increasing uncertainty concerning trade, tariffs, regulations as well as international and even inter-ally co-operation....

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2018.0702.010

3.120 views

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