Articles

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

1.631 views

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Research News

Published on 25 January 2024

Infliximab discontinuation in patients with originator retransition vs biosimilar continuation

Submitted: 4 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 2023 A study by Meijboom et al. aimed to compare the risk of and...

DOI: 10.5639/gabij.2023.1203.017

1.137 views

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Research News

Published on 11 January 2024

Switches between biosimilars and their reference products

Submitted: 22 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 2023 Biologics are the fastest-growing class of medications in the United States and account...

Author(s): Sarah Schrieber, PharmD

DOI: 10.5639/gabij.2023.1203.016

4.328 views

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Original Research

Published on 11 January 2024

Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software

Author byline as per print journal: Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; Manoj Gundeti2, MPharm; Nagarjun Rangaraj1, MPharm, PhD; Anup Avijit Choudhury1, MPharm; Tausif Ahmed2, MPharm,...

etoricoxib, GastroPlus®, modelling and simulation, PBBM, spray granulation, virtual bioequivalence

DOI: 10.5639/gabij.2024.1301.003

3.874 views

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Editor's Letter

Published on 10 January 2024

Latest features in GaBI Journal, 2023, Issue 3

The articles in this issue of the GaBI ­Journal highlight two important issues that must be considered when reading scientific publications. The first two articles illustrate the rapidly expanding influence...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1203.012

1.198 views

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Review Article

Published on 18 October 2023

Trends in Saudi FDA drug approvals and GMP inspections: an observational study

Author byline as per print journal: Ali M Alhomaidan, PhD; Mohammed Abdulaziz Alageel, MSc; Turki Abdulaziz Alrafie, MSc; Hassan Mohammed Alqarni, MSc; Ibraheem Yahya Khbrani, MSc; Dalal J Alkhamis, MSc;...

Common Technical Documents, drug regulation, good manufacturing practice, Saudi FDA

DOI: 10.5639/gabij.2023.1203.013

8.743 views

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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

1.346 views

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Meeting Report

Published on 14 September 2023

Medicare drug price negotiations: impact on healthcare development and patient access to medicines

Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Esq; Steven J Potts, PhD, MBA; Andrew Spiegel, Esq Introduction: In the...

DOI: 10.5639/gabij.2023.1203.015

8.119 views

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Sponsored Article

Published on 14 September 2023

Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation

Abstract: Undoubtedly the complexity of antibody drug conjugate (ADC) molecules where three components (monoclonal antibody, cytotoxic drug and appropriate linker) are involved poses a challenge for biosimilar development. As with...

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

antibody-drug conjugates, biosimilarity, characterization techniques, higher order structure, orthogonality, protein aggregation

DOI: 10.5639/gabij.2023.1203.018

3.827 views

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Review Article

Published on 14 September 2023

The incorporation of the Halal Management System (HMS) by the pharmaceutical industry

Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri2,3; Noor Fadzilah Zulkifli1; Mohd Mahyeddin Mohd Salleh3; Nazariyah Yahaya4; Khairun Nain Nor Aripin1; Shahirah Nadiah Shaharuddin5;...

halal assurance, halal pharmaceuticals, oral dosage, supply chain

DOI: 10.5639/gabij.2023.1203.014

8.276 views

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Perspective

Published on 08 August 2023

Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?

Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ankit Ranpura1, MD; Kuldeep Kumar1, PhD; Elena Wolff-Holz2, MD Abstract: Ethnic...

biosimilar development, ethnic sensitivity assessments, global access, monoclonal antibodies, multi-regional clinical trials, regulatory reforms

DOI: 10.5639/gabij.2023.1202.010

11.306 views

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Review Article

Published on 04 May 2023

Statistical tests for detecting reference product change in biosimilar studies

Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang`2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD Abstract: For the biosimilarity assessment between a test product and a reference...

DOI: 10.5639/gabij.2023.1202.009

5.030 views

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