Forthcoming Issue

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, 2018, Issue 2 / Professor Philip D Walson, MD, USA/Germany

Commentary

Potential changes to the FDA approach to biosimilars have a global impact / Adjunct Professor Pekka Kurki, MD, PhD

Medicines regulation in the Middle East and the importance of the World Health Organization’s INN proposal of Biological Qualifier / Peter J Pitts, BA; Michael S Reilly, Esq

Original Research

Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2 / Magaly Perez-Nieves, MPh, PhD; Robyn K Pollom, ANP; Ran Duan, PhD; Samaneh Kabul, PharmD; Amy M DeLozier, MPh; Puneet Kaushik, MPharm; Liza L Ilag, MD

Extended stability study of a biosimilar of trastuzumab (CT-P6) after reconstitution in vials and after dilution in polyolefin bags and storage at fridge and room temperatureBioequivalence Study of Two Formulations of 60 mg Daclatasivir in Healthy Volunteers / Victoire Vieillard, PharmD; Professor Alain Astier, PharmD, PhD; Muriel Paul, PharmD

Building trust on biosimilars: Continuous safety surveillance of a biosimilar Bevacizumab (BEVAX®) in Argentina / Francisco Fernández, MD; Matías Deprati, MD; Patricia Rodríguez Acedo; Eduardo Spitzer, BSc; Alvaro Romera, MD; Nadia Español, BSc

Review Article

Protein heterogeneity and the immunogenicity of biotherapeutics / Professor Roy Jefferis, UK

In vitro analytical and antibiotic comparison of generic medicine of Moxifloxacin against E. coli and S. aureus bacteria strains / Antistio Alviz-Amador, Jairo E Mercado Camargo, Marlene Duran-Lengua

Biocomparable Drugs in Mexico: Challenges and Opportunities in the Treatment of Gaucher Disease / L Carbajal-Rodríguez, MD; M Cerón-Rodríguez, MD; Professor LC Correa-González; A Esquivel-Aguilar, PhD; SJ Franco-Ornelas, MD; JE García Ortiz, PhD; CM Hernández-Guadarrama, MD; JI Navarrete-Martínez; E Terreros-Muñoz, MD; Mexico

Perspective

How to realize the potential of off-patent biologicals and biosimilars in Europe? Guidance to policymakers / Simoens, Steven, Belgium; Le Pen, Claude, France; Boone, Niels, The Netherlands; Breedveld, Ferdinand, The Netherlands; Celano, Antonella, Italy; Llombart Cussac, Antonio, Spain; Jorgensen, Frank, Norway/BE; Süle, Andras, Belgium; van Bodegraven, Ad, The Netherlands; Westhovens, René, Belgium; De Cock, Jo, Belgium

Regulatory

Regulation of copy biologicals in China / Michelle Derbyshire, PhD, GaBI Online Editor

Biosimilar regulation and approval in Jordan / Hayel Obeidat; Rana Musa Malkawi; Wesal Salem Al-haqaish

Meeting Report

Quality assessment of biosimilars in Colombia – reducing knowledge gaps / Elaine Gray, PhD; Paul Matejtschuk, PhD, CChem; Robin Thorpe, PhD, FRCPath

First ASEAN educational workshop on regulation and approval of biosimilars/similar biotherapeutic products 2017 – Report / Robin Thorpe, PhD, FRCPath; Elwyn Griffiths, PhD, DSc; Niklas Ekman Ekman, PhD

Opinion

Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance / Adjunct Professor Sarfaraz K Niazi, PhD, SI, FRSB, FPAMS, FACB

Abstracted Scientific Content

A call for coherence in EU legislation to promote generics / Alice Rolandini Jensen, MSci, GaBI Journal Editor

EU risk-sharing agreements between 2000-2015 / Alice Rolandini Jensen, MSci, GaBI Journal Editor

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.

Last update: 2018-11-02 Go Back Print

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