Articles

Published on 27 October 2020

2020/3 GaBI Journal Table of Contents

Contents Editor’s Letter Latest features in GaBI Journal, 2020, Issue 3, 2020, Issue 3 Commentary Quality standards for biopharmaceuticals: the importance of good manufacturing practice Original Research Qualitative survey-based evaluation...

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Editor's Letter

Published on 30 November 2020

Medical journal publication during global stress

This issue of the GaBI Journal is being published during one of the most turbulent periods in over a century. A deadly pandemic is raging, the global economy is stressed,...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2020.0904.023

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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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Published on 24 March 2020

2020/1 GaBI Journal Table of Contents

Contents Editor’s Letter Editor’s introduction to the initial issue of the ninth volume of GaBI Journal Original Research Stability of the trastuzumab biosimilar ABP 980 compared to reference product after...

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Published on 09 July 2020

2020/2 GaBI Journal Table of Contents

Contents Editor’s Letter What to look forward to in GaBI Journal, 2020, Issue 2 Commentary Importance of the determination of the higher order structure in the in-use stability studies of...

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Review Article

Published on 30 July 2024

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

Abstract:Drug development is among the highest producers of greenhouse gas (GHG) emissions, with about 4.4%–4.6% of the worldwide GHG emissions coming from the thousands of clinical trials being carried out...

Author(s): Shivani Mittra, MPharm, PhD, Shylashree Baraskar, MBBS, Elena Wolff-Holz, MD, Sandeep N Athalye, MBBS, MD

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

DOI: 10.5639/gabij.2024.1303.033

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Thank you to reviewers

Published on 02 October 2019

Thank you to reviewers 2018

The editors and publisher wish to express their gratitude to the colleagues listed below for their valuable contribution to the peer review process for the Generics and Biosimilars Initiative Journal...

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Published on 02 December 2020

2020/4 GaBI Journal Table of Contents

Contents Editor’s Letter Medical journal publication during global stress Editorial Is the local tolerance of injectable biosimilars too underestimated? Commentary A white paper: US biosimilars market on pace with Europe...

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Editor's Letter

Published on 16 December 2021

Fourth and final issue of GaBI Journal’s 10th volume

This issue of the GaBI Journal contains only a limited number of articles, but these include two scientific very data-rich articles and an interesting and important expose on the use...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1004.020

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Perspective

Published on 23 August 2024

The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies

Abstract:This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It provides...

Author(s): Takanao Hashimoto, PhD, Akihiko Ozaki, MD, PhD, Hiroaki Saito, MD, Erika Yamashita, Tetsuya Tanimoto, MD, Professor Mihajlo (Michael) Jakovljevic, MD, PhD, MAE

COVID-19 pandemic, drug shortages, generic drugs, good manufacturing practice, pharmaceutical policy

DOI: 10.5639/gabij.2024.1303.036

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Published on 26 April 2022

2022/1 GaBI Journal Table of Contents

Contents Editor’s Letter First 2022 GaBI Journal issue highlights Letter to Editor No need for systematic switch studies to demonstrate interchangeability of biosimilars Review Article Biotherapeutic products in the European...

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Editor's Letter

Published on 26 April 2022

First 2022 GaBI Journal issue highlights

The first GaBI Journal issue of 2022 comes at a time of both hope and despair. While the COVID-19 pandemic continues to cause significant global morbidity and mortality; especially in...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1101.001

1.781 views

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