Articles

Perspective

Published on 18 November 2013

Role of hospital clinical pharmacist in transplantation, and generic immunosuppressive therapies

Abstract: The pharmacist is an important patient advocate in the transplant multidisciplinary team and can support patients in their medication taking to improve medication adherence. Medicine optimization and patient information...

Author(s): Andrea Devaney

generics substitution, immunosuppressant, self-medication, tacrolimus, transplantation

DOI: 10.5639/gabij.2014.0302.023

26.092 views

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Review Article

Published on 24 March 2014

Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective

Author byline as per print journal: Niels Eckstein, PhD; Lea Röper, BSc; Bodo Haas, PhD; Henrike Potthast, PhD; Ulrike Hermes, PhD; Christoph Unkrig, MD; Frauke Naumann-Winter, PhD; Harald Enzmann, MD Aim: To provide a systematic overview on: i)...

Author(s): Bodo Haas, PhD, Christoph Unkrig, MD, Frauke Naumann-Winter, PhD, Harald Enzmann, MD, Henrike Potthast, PhD, Lea Röper, BSc, Niels Eckstein, PhD, Ulrike Hermes, PhD

generics, narrow therapeutic index drugs (NTDI), orphan drug status, product-specific bioequivalence guidance, tyrosine kinase inhibitors (TKI)

DOI: 10.5639/gabij.2014.0302.021

19.053 views

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Review Article

Published on 22 January 2014

Clinical development, immunogenicity, and interchangeability of follow-on complex drugs

Abstract: Although not derived from living sources, non-biological complex drug (NBCD) products have the immunogenicity and molecular complexity of biological drugs. NBCDs typically contain heterogenous mixtures of closely related nanoparticulate...

Author(s): J Michael Nicholas, PhD

follow-on drugs, glatiramoids, iron-carbohydrate complex, liposomes, NBCD, non-biologic complex drugs

DOI: 10.5639/gabij.2014.0302.020

32.098 views

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Original Research

Published on 24 March 2014

Biosimilars naming, label transparency and authority of choice – survey findings among European physicians

Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The...

Author(s): Michael S Reilly, Esq, Richard O Dolinar, MD

biological, biosimilar, Europe, INN, pharmacy substitution, prescriber

DOI: 10.5639/gabij.2014.0302.018

21.274 views

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Original Research

Published on 24 March 2014

Perceptions of physicians from private medical centres in Malaysia about generic medicine usage: a qualitative study

Introduction: The healthcare sector is one of the most rapidly expanding and dynamic industries in the world. Pharmaceutical expenditure is now growing faster than other components of healthcare overheads. Globally,...

Author(s): Muhamad Ali SK Abdul Kader, MD, Rohit Kumar, MPharm, Mohamed Azmi Ahmad Hassali, PhD, Navneet Kaur, PhD

generics, Malaysia, perceptions, pharmaceuticals, private hospitals

DOI: 10.5639/gabij.2014.0302.019

22.174 views

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Pharma News

Published on 26 March 2014

New EU guidance for the evaluation of medicinal products with modified drug release will be finished by the middle of 2014

Submitted: 2 March 2014; Revised: 7 March 2014; Accepted: 8 March 2014; Published online first: 21 March 2014 The guideline ‘Note for guidance on modified release oral and transdermal dosage...

Author(s): Christoph Baumgärtel, MD, MSc, Jan Neuhauser, MD

DOI: 10.5639/gabij.2014.0302.024

9.595 views

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Commentary

Published on 22 January 2014

Defining and characterizing non-biological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection

Abstract: ‘Non-binding recommendations’ from regulatory bodies are in place for evaluation and production of generic liposomal doxorubicin injection. However, how these nano-sized generics (‘nanosimilars’) should be characterized and evaluated, and...

Author(s): Professor S Moein Moghimi, PhD, Z Shadi Farhangrazi, PhD

adverse reactions, complement system, immunogenicity, liposome, nanoparticle size, vesicle morphology

DOI: 10.5639/gabij.2014.0302.017

22.879 views

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Editor's Letter

Published on 11 June 2014

What to look forward to in GaBI Journal, 2014, Issue 2

As mentioned previously, non-biological complex drugs (NBCDs) continue to raise important regulatory and practice issues. This issue of the GaBI Journal contains a number of manuscripts dealing with these products...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0302.015

7.119 views

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Meeting Report

Published on 18 November 2013

First Asia-Pacific educational workshop on non-biological complex drugs (NBCDs), Kuala Lumpur, Malaysia, 8 October 2013

Author byline as per print journal: Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD, Beat Flühmann, PhD Introduction: In recent years a new category of medicinal products, the non-biological...

Author(s): Beat Flühmann, PhD, Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD

follow-on drugs, nanomedicines, NBCD, non-biologic complex drugs, regulatory practice

DOI: 10.5639/gabij.2014.0301.010

14.162 views

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Special Report

Published on 18 November 2013

Analysis of European policy towards generic medicines

Abstract: In this paper, we provide an overview of a PhD project we undertook on European policy on generic medicines. In the course of our research, we identified various causes...

Author(s): Pieter Dylst, PharmD, Professor Arnold G Vulto, PharmD, PhD, FCP, Steven Simoens, MSc, PhD

demand-side policies, Europe, European policy, generic medicines, supply-side policies

DOI: 10.5639/gabij.2014.0301.011

16.426 views

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