Peer review articles planned or manuscripts submitted for peer review approval and publication in the forthcoming issues.
Online First
Online First articles have been peer reviewed, accepted for publication and published online; they have not yet been assigned to a journal issue. When an article is published in a journal issue with the assigned page number, it will be removed from the ‘Forthcoming Issue’ page.
Online First articles are copyedited by the science editors and the editorial production team; typeset, proofread and approved by the author(s) before publication. We aim to post each article within six weeks of acceptance and within two weeks after final proofreading approval by the author. Online First articles are in searchable full text, with the initial online publication date included in the final print version.
Articles appearing on the ‘Forthcoming Issue’ page are in the order of the Journal Editorial Sections. You may also view the abstract by clicking on the article link.
Subscribe now to the print or PDF copy of GaBI Journal to view full information of the following manuscripts*.
Editor’s Letter
First 2024 GaBI Journal issue highlights / Robin Thorpe, PhD, FRCPath, UK
Latest features in GaBI Journal, 2023, Issue 3 / Professor Philip D Walson, MD, USA
Original Research
Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile / Tomás Abbot1, MSc; Nicolás Armijo1, MSc; Robin Piron2, PhD; Manuel Espinoza1, 3, PhD, Chile
Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software / Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; Manoj Gundeti2, MPharm; Nagarjun Rangaraj1, MPharm, PhD, MPharm; Anup Avijit Choudhury1, MPharm; Tausif Ahmed2, MPharm, PhD; Venkat Ramana Naidu1, MPharm, PhD, India
Review Article
Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials / Sandeep N Athalye, MBBS, MD; Shylashree Baraskar, Shivani Mittra, MPharm, PhD; Elena Wolff-Holz, MD; India/Germany
Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries / Pritha Paul1, PhD; Rahul Kapur2,*, MBBS, PhD; Shivani Mittra2, MPharm, PhD; Nimish Shah3, JD, MBA; Gopal K Rao1, MSc; Matthew E Erick4, BS, RPh; Susheel Umesh1, BPharm, MBA; Sandeep N Athalye2, MBBS, MD, India
Trends in Saudi FDA drug approvals and GMP inspections: an observational study / Dr Ali M Alhomaidan; Mohammed Abdulaziz Alageel; Turki Abdulaziz Alrafie; Hassan Mohammed Alqarni; Ibraheem Yahya Khbrani; Dalal J Alkhamis; Mohammed F Alkhalifah; Abdualmajeed S bin Jumaiah; Dr Mohammed A Dahhas, Saudi Arabia
The incorporation of the Halal Management System (HMS) by the pharmaceutical industry / Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri3; Noor Fadzilah Zulkifli1; Mohd Mahyeddin Mohd Salleh3; Nazariyah Yahaya4; Khairun Nain Nor Aripin1; Shahirah Nadiah Shaharuddin5; Seri Azalina Mohd Ghazalli6;Muhammad Syazan Sulaiman6, Malaysia
Perspective
Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health / Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF, USA
Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort / Adjunct Professor Pekka Kurki, MD, PhD / Finland
Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements / Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay Singhvi, BSc (Hon), MBBS, MBA, Germany/UK
Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not? / Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ankit Ranpura1, MD; Kuldeep Kumar1, PhD; Elena Wolff-Holz2, MD, India/Germany
Opinion
Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars / Michael S Reilly, Esq, USA
Special Report
Extended stability data on small molecule anticancer medicinal products – anything new? any additional information necessary? / Professor Irene Krämer, PhD; Judith Thiesen, PhD, Germany
Meeting Report
Medicare drug price negotiations: impact on healthcare development and patient access to medicines / Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Steven J Potts, PhD, MBA; Andrew Spiegel, Esq, USA/Canada
Research News
Switches between biosimilars and their reference products / Dr Sarah Schrieber, PharmD, US FDA
Infliximab discontinuation in patients with originator retransition vs. biosimilar continuation / Rosanne Meijboom, The Netherlands
Regulatory
Regulatory pathway for approval of ‘biosimilars’ in Iran / Jalal Naeli, MD, Iran
Sponsored Article
Biosimilar antibody drug conjugates: considerations of higher order structure and aggregation / Easton RL, BSC (Hons), DIC, PhD, UK
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*Editorial content may differ from final version of manuscript published in print.