Original Research

Published on 28 November 2023

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, PhD; Venkat Ramana Naidu1, MPharm, PhD Introduction: In this work, we present model` guided development of a new Etoricoxib tablet formulation using a proprietary technology.…

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

DOI: 10.5639/gabij.2024.1301.003

Editor's Letter

Published on 16 December 2016

Fourth and final issue of GaBI Journal’s fifth volume

This fourth and final GaBI Journal issue of 2016 begins with the paper by Adjunct Professor Pekka Kurki about ‘applying ancient principles in a modern society’ in which he discusses a perspective recently published in our journal from Annese et al. that presented the skeptical views expressed by Italian gastroenterologists concerning extrapolation of indications for…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0504.038

Editor's Letter

Published on 17 December 2014

Fourth and final issue of GaBI Journal’s third volume

The interest in the development, regulatory approval, use, and post-marketing surveillance of generic and biosimilar pharmaceutical products continues to increase; as illustrated by the tremendous number of views (over 1,028,324 since 2012) of articles published in the GaBI Journal. I expect that this interest will continue to increase after publication of this fourth and final…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0304.036

Submitted: 20 June 2018; Revised: 14 August 2018; Accepted: 18 August 2018; Published online first: 31 August 2018 The ageing population, longer life expectancies, and the increasing cost of drugs are expected to significantly increase the burden on healthcare systems in the coming years. To reduce this burden and increase access to new, innovative and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0703.026

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 to medicines worldwide through review and approval of quality generic drug products that are interchangeable with the corresponding reference medicinal product. The Bioequivalence Working Group…

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

DOI: 10.5639/gabij.2021.1003.019

Editor's Letter

Published on 26 March 2015

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

This first 2015 GaBI Journal issue (fourth volume of the journal) is being published soon after the first US biosimilar approval and it contains a number of articles that illustrate how the development, marketing and acceptance of biosimilars differ globally including in North and South America and the Persian Gulf States. An Editorial entitled Biosimilars:…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0401.001

Submitted: 6 May 2018; Revised: 7 May 2018; Accepted: 8 May 2018; Published online first: 18 May 2018 Data and market exclusivity for originator medicines in the European Union (EU) create a barrier to market entry for generic medicines. Legislation means that generics cannot reach the market for at least 10 years following the originator…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0702.019

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, BSc; Rajavikraman Boopathy1, DipSc; Shahnun Ahmad1, MBBS; Atiqah Amran1, BSc; Raman Batheja2, PhD; Rajan Sharma2>, MBBS; Kiran Kumar Vuppalavanchu2, MPharm Introduction/Study Objectives: The aim of…

bioequivalence, new branded generics, pharmacokinetics, sitagliptin

DOI: 10.5639/gabij.2023.1201.003

Editor's Letter

Published on 16 September 2015

Latest features in GaBI Journal, 2015, Issue 3

This issue of the journal contains a number of manuscripts that discuss proposals to simplify the evaluation of, and therefore decrease the cost of developing, follow-on biological products. These controversial proposals include extrapolation of indications, abbreviated approval processes in resource-poor countries, biological/biosimilar nomenclature, and patent litigation strategies. Dr Frits Lekkerkerker, reviews the paper by Gerrard…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2015.0403.022

Sponsored Article

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 confidence in the data obtained from characterization studies? The expectation from regulatory authorities when assessing methods for product characterization is that there will be some…

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

Contents Editor's Letter Introduction to the GaBI Journal Editorial Generic medicine pricing: on track in Europe? Commentary Innovator companies should focus on innovations Review Article A review of generic medicine pricing in Europe Biologicals and biosimilars: a review of the science and its implications A patient-centred paradigm for the biosimilars market European payer initiatives to…

Human immunodeficiency virus (HIV) patients in high-income countries are likely to accept the introduction of generic antiretroviral (ARV) drugs, according to a study carried out by researchers in Ireland [1]. Between July and August 2015, a survey of 66 patients was carried out in one-to-one interviews at St James Hospital, Dublin, Ireland. Descriptive and univariate…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.041