Articles

Published on 22 October 2014

2014/2 GaBI Journal Table of Contents

Contents Editor's Letter What to look forward to in GaBI Journal, 2014, Issue 2 Editorial Complex molecules – current developments Commentary Defining and characterizing nonbiological complex drugs (NBCDs) – Is...

3.176 views

Read more →

Published on 22 October 2014

2014/1 GaBI Journal Table of Contents

Contents Editor's Letter Editor’s introduction to the initial issue of the third volume of GaBI Journal Editorial Drug shortages hit US oncologists hard Letters to the Editor Common or distinct...

3.387 views

Read more →

Published on 22 October 2014

2013/4 GaBI Journal Table of Contents

Contents Editor's Letter GaBI Journal publishes four issues in 2013 Editorial Suggested evaluation of biological drugs role for WHO – Editor’s response Do low- to middle-income countries need a biosimilar...

2.985 views

Read more →

Published on 22 October 2014

2013/3 GaBI Journal Table of Contents

Contents Editor's Letter Latest features in GaBI Journal, 2013, Issue 3 Editorial Italy’s final position paper on biosimilars and new price and reimbursement pathway Commentary Commentary on the recommendations of...

3.045 views

Read more →

Published on 22 October 2014

2013/2 GaBI Journal Table of Contents

Contents Editor's Letter What to look forward to in GaBI Journal, 2013, Issue 2 Editorial National and regional activities by sickness funds in Austria to encourage the rational use of...

3.524 views

Read more →

Published on 22 October 2014

2013/1 GaBI Journal Table of Contents

Contents Editor's Letter Editor’s introduction to the wide range of topics in the initial issue of the second volume of GaBI Journal Letters to the Editor The ethics of biosimilars...

3.394 views

Read more →

Published on 22 October 2014

2012/3-4 GaBI Journal Table of Contents

Contents Editor's Letter Latest features in GaBI Journal, 2012, issue 3-4 Letters to the Editor A bioethicist’s view of the use of biosimilars A clinician’s view of the ethics of...

3.266 views

Read more →

Published on 22 October 2014

2012/2 GaBI Journal Table of Contents

Contents Editor's Letter What to look forward to in GaBI Journal, 2012, issue 2 Editorial Equal protection under the law: Children and the Best Pharmaceuticals for Children Act Regulatory Tighter...

3.210 views

Read more →

Published on 16 October 2014

2012/1 GaBI Journal Table of Contents

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...

3.578 views

Read more →

Regulatory

Published on 23 September 2014

Regulation of biologicals in Malaysia

Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises...

Author(s): Arpah Abas, BPharm, Yvonne Siew Khoon Khoo, BPharm (Hons) MMedSc, PhD (Pharmacology)

biologicals, evaluation, Malaysia, National Pharmaceutical Control Bureau (NPCB), regulation

DOI: 10.5639/gabij.2014.0304.044

17.685 views

Read more →

Abstracted Scientific Content

Published on 23 September 2014

Pharmaceutical policy interventions in times of economic recession

Two countries that were affected by the recent economic recession in different ways, and amended their pharmaceutical policies very differently, have provided researchers with an invaluable data set pointing to...

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.049

5.955 views

Read more →

Review Article

Published on 05 September 2014

Safety assessment of biosimilars in Europe: a regulatory perspective

Abstract: Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines...

Author(s): Christian K Schneider, MD, Thijs J Giezen, PharmD, PhD, MSc

biosimilar, clinical safety, immunogenicity, pharmacovigilance

DOI: 10.5639/gabij.2014.0304.041

13.809 views

Read more →