Articles

Published on 29 September 2021

2021/3 GaBI Journal Table of Contents

Contents Editor’s Letter Latest features in GaBI Journal, 2021, Issue 3 Original Research Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers Reasons for patients’ generic drug switching at the...

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Published on 17 December 2021

2021/4 GaBI Journal Table of Contents

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s 10th volume Original Research Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices Review...

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Review Article

Published on 26 June 2024

Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials

Author byline as per print journal: Shivani Mittra1, MPharm, PhD; Shylashree Baraskar1, MBBS; Elena Wolff -Holz2, MD; Sandeep N Athalye1, MBBS, MD Abstract:Drug development is among the highest producers of...

biological, biosimilars, carbon footprint, clinical trials, ESG (Environmental Social Governance), sustainability

DOI: 10.5639/gabij.2024.1303.033

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Editor's Letter

Published on 29 December 2022

The importance of trust

It seems as if the entire world is dealing with a lack of trust, even in many things that have enriched and sustained human development, including our neighbours, teachers, the...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1103.014

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Sponsored Article

Published on 04 April 2022

Biosimilar monoclonal antibodies development simplified

Author(s): Jennifer Campbell

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Perspective

Published on 06 March 2024

Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements

Author byline as per print journal: Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay Singhvi, BSc (Hon), MBBS, MBA Introduction: Healthcare providers often lack familiarity...

biosimilar, education, oncology, regulatory

DOI: 10.5639/gabij.2024.1301.005

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Editor's Letter

Published on 03 May 2023

Lagging acceptance of generic and biosimilar drug products; the rest of the story

The article in this issue of the GaBI Journal reminded me of The Rest of the Story radio programme originally hosted by Mr Paul Harvey that started each episode with,...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1201.001

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Editor's Letter

Published on 14 September 2023

Extrapolation requires reading between the lines

The articles in this second issue of 2023 include an Original Research (Internet questionnaire) of the ‘opinions’ of Canadian ophthalmologists, a Review Article describing a statistical method to assess the ‘drift’...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1202.007

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Editor's Letter

Published on 08 September 2022

What to look forward to in GaBI Journal, 2022, Issue 2

The rate of successful development, regulatory approval and marketing of both new and follow-on biological treatments has continued to accelerate despite, and in some cases because of, a seemingly endless...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1102.008

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Review Article

Published on 18 November 2024

A review of international initiatives on pharmaceutical regulatory reliance and recognition

Abstract: In light of recent global health challenges, the need for regulatory reliance – where one regulatory authority accepts the decisions of another – has gained significant interest and momentum....

Author(s): Vimal Sachdeva, MSc

authorization, best practice, harmonization, pharmaceuticals, recognition

DOI: 10.5639/gabij.2024.1303.034

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