Articles

Review Article

Published on 07 April 2022

Long-acting insulin analogues. Drug selection by means of the System of Objectified Judgement Analysis (SOJA)

Author byline as per print journal: Robert Janknegt, PharmD, PhD; Marloes Dankers, MSc Study objectives: The increasing number of long-acting insulin analogues makes it difficult for general practitioners to have...

degludec, detemir, diabetes mellitus, glargine, long-acting insulin analogues, NPH insulin

DOI: 10.5639/gabij.2022.1101.005

5.353 views

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Review Article

Published on 28 February 2022

Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Adelia Pheh1, BSc (Pharm) (Hon); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm)...

challenges, COVID-19 vaccines, harmonization, manufacturing, regulation, traditional vaccines

DOI: 10.5639/gabij.2022.1101.004

10.384 views

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Review Article

Published on 28 January 2022

Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled?

Author byline as per print journal: Mihaela Buda, PhD; Olga Kolaj-Robin, PhD; Emmanuelle Charton, PhD Abstract: The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs in the field of...

biosimilars, biotherapeutics, monographs, pharmacopoeia, public standards

DOI: 10.5639/gabij.2022.1101.003

5.780 views

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Letters to the Editor

Published on 17 December 2021

No need for systematic switch studies to demonstrate interchangeability of biosimilars

Abstract: Systematic clinical switch studies to demonstrate interchangeability of biosimilars are required in some jurisdictions while theoretical considerations and current clinical data question the feasibility and relevance of such studies....

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

biosimilars, immunogenicity, interchangeability, switch studies

DOI: 10.5639/gabij.2022.1101.002

6.737 views

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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

1.777 views

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Review Article

Published on 03 December 2021

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

Author byline as per print journal: Esteban Ortiz-Prado1, MD, MSc, MPH, PhD(c); Enrique Teran2, MD, PhD; Raul Patricio Fernandez Naranjo1, MSc; Doménica Cevallos-Robalino1, MD; Eduardo Vasconez1, MD; Alex Lister3, MPH At...

biosimilars, black market, COVID-19 pandemic, interleukins, tocilizumab

DOI: 10.5639/gabij.2021.1004.023

10.162 views

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Review Article

Published on 29 September 2021

The European framework for intellectual property rights for biological medicines

Author byline as per print journal: Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to...

biological medicines, European intellectual property rights, market access, pricing, R & D

DOI: 10.5639/gabij.2021.1004.022

10.846 views

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Original Research

Published on 29 September 2021

Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in polyolefin bags and elastomeric devices

Author byline as per print journal: Lyndsay Davies1, PhD; Katie Milligan1, BSc; Mark Corris1, BSc; Ian Clarke1; Paul Dwyer1, MSc; Sarah Elizabeth Lee2, PhD; Jolene Teraoka3, BSc; Jill Crouse-Zeineddini3, PhD; Jane...

biosimilar, elastomeric device, KANJINTI® ABP 980, stability, trastuzumab

DOI: 10.5639/gabij.2021.1004.021

8.867 views

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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

1.853 views

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Abstracted Scientific Content

Published on 22 June 2021

An IPRP survey of the regulatory requirements for the waiver of in vivo bioequivalence studies of generic medicinal products in certain dosage forms

Submitted: 14 May 2021; Revised: 14 May 2021; Accepted: 3 June 2021; Published online first: 10 June 2021 Medicines regulatory authorities aim to address rising healthcare costs and promote access...

Author(s): Alfredo García Arieta, PhD, Clare Rodrigues

DOI: 10.5639/gabij.2021.1003.019

3.683 views

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Pilot Study

Published on 30 August 2021

Use of biologicals in dermatology – following the agreed path or going off-piste? A brief report

Author byline as per print journal: Michael Wilcock, MPhil; Andrew Pothecary, MSc Introduction: Biological medicines are used to treat a range of conditions according to National Institute for Health and...

biologicals, biosimilars, dermatology, psoriasis

DOI: 10.5639/gabij.2021.1003.018

6.112 views

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Review Article

Published on 22 June 2021

Microbiological, scientific and regulatory perspectives of hand sanitizers

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Tan Ying Ting, BSc Pharm (Hons); Associate Professor Chan Lai Wah, BSc Pharm (Hons), PhD...

effectiveness, hand sanitizers, myths, regulatory framework, safety, standards

DOI: 10.5639/gabij.2021.1003.017

8.991 views

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