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

What to look forward to in GaBI Journal, 2024, Issue 2 / Robin Thorpe, PhD, FRCPath, UK

First 2024 GaBI Journal issue highlights / Robin Thorpe, PhD, FRCPath, UK

Letters to the Editor

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 Espinoza^{1, 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

A review of international initiatives on pharmaceutical regulatory reliance and recognition / Vimal Sachdeva, MSc, Switzerland

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 Kapur^2,*, 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

Perspective

US interchangeability designation: are we ready to cut the Gordian knot? / Joseph P Park, PhD; Gillian R Woollett, MA, DPhil, South Korea

The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies / Takanao Hashimoto1, PhD; Akihiko Ozaki2, MD, PhD; Hiroaki Saito3, MD; Erika Yamashita4; Tetsuya Tanimoto5, MD; Mihajlo Jakovljevic6,7,8, MD, PhD, Japan

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

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

Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bottles / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Cisplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride solution / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Cytarabine Accord in punctured original vials and after dilution with 0.9% sodium chloride solution in polyolefine bags / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Docetaxel Accord 20 mg/mL concentrate diluted with 0.9% sodium chloride or 5% glucose solution in non-PVC bags / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Doxorubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyethylene bottles / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Epirubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine bags / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Etoposide Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Fludarabine Accord in punctured original vials and after dilution with 0.9% sodium chloride solution / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Fluorouracil Accord in three different concentrations in portable elastomeric infusion pumps / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Gemcitabine Accord 100 mg/mL in punctured original vials and after dilution with 0.9% sodium chloride in polyolefine bags / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Idarubicin Accord in punctured original vials, syringes and after dilution with water for injection / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Irinotecan Accord in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine bags / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Methotrexate Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bags / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Mitoxantrone Accord after dilution with 0.9% sodium chloride solution in polyolefine bags / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Oxaliplatin Accord 5 mg/mL in punctured original vials and after dilution with 5% glucose solution in polyethylene bottles and polyolefine bags / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Pemetrexed Accord 25 mg/mL in punctured original vials and after dilution with 0.9% sodium chloride solution in non-PVC bottles / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Topotecan Accord after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine and non-PVC bags / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Vinorelbine Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution / Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Interview

Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion

Regulatory

Regulatory pathway for approval of ‘biosimilars’ in Iran / Jalal Naeli, MD, Iran

Click here for more details on the educational series.

Contact us for an updated list of editorial topics in forthcoming issues.

*Editorial content may differ from final version of manuscript published in print.