Peer review articles planned or manuscripts submitted for peer review approval and publication in the forthcoming issues.
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 introduction to the initial issue of the seventh volume of GaBI Journal / Professor Philip D Walson, MD, USA/Germany
Letters to the Editor
Comment on the non-biological complex drugs paper / Karthik Bodhinathan, PhD, MSM
EU Member States have tools to reduce costs of bestseller biologicals but can they use them? / Adjunct Professor Pekka Kurki, MD, PhD
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 Biological Qualifier Program / Peter J Pitts, Former Associate Commissioner, United States Food & Drug Administration, USA
Analysis of Drug Master Files Registered in Japan: For the Stable Supply of Active Pharmaceutical Ingredients / Maki Matsuhama, Ryosuke Kuribayashi, Japan
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
Bioequivalence Study of Two Formulations of 60 mg Daclatasivir in Healthy Volunteers / Sattam Turky AlGhodyyr, MSc; Mohammad Khalil, Mohammad, R.Ph., Ph.D; Sanabel Omar Dawabsheh; Mohammad Ali Abu Fara, MD; Majdi Naser Abu Al Hajj; Rabab Fayyez Tayyem, PhD
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
Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence / Gary L O’Brien, BPharm, MPharm; Donal Carroll, BSc (Hon) Pharmacy; Mark Mulcahy, BComm, MSc, PhD; Valerie Walshe, BA, MA, PhD; Professor Garry Courtney, MB, FRCPI; Professor Stephen Byrne, BSc (Hon) Pharmacy, PhD
The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US / Hajaj M Alhomaidan; Ali M Alhomaidan, PhD
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
Regulations for biotherapeutics approval in Colombia / Johanna Andrea García Cortes, MSc; Francisco Javier Sierra Esteban, MSc
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
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
Patent expiry dates for biologicals: 2017 update / Michelle Derbyshire, PhD, GaBI Online Editor
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 / Robin Thorpe, PhD, FRCPath; Elwyn Griffiths, DSc, PhD; Niklas Ekman Ekman, PhD
Rationalizing FDA guidance on biosimilars—expediting approvals and acceptance / Adjunct Professor Sarfaraz K Niazi, PhD, SI, FRSB, FPAMS, FACB
Top developments in biosimilars during 2017 / Michelle Derbyshire, PhD, GaBI Online Editor
Abstracted Scientific Content
Barriers to generics policy reform: a US case study / Eleanor Bird, BSc (Hons), GaBI Journal Editor
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.