Articles

Commentary

Published on 18 April 2016

Waiver of consent for retrospective chart review studies

Abstract: The importance of obtaining IRB/EC consent for waiver of consent before embarking on retrospective chart review studies was highlighted using the recent case of a manuscript submitted to GaBI...

Author(s): Professor Philip D Walson, MD

chart review, consent, retrospective, waiver

DOI: 10.5639/gabij.2016.0501.004

16.121 views

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Original Research

Published on 09 February 2016

Views of physicians and patients with chronic conditions on generic medicines in Greece after the introduction of measures to promote their consumption: findings from a qualitative study

Author byline as per print journal: Eleftheria Karampli, MSc; Estathia Triga, MSc; Vasiliki Tsiantou, MSc; Kostas Athanasakis, PhD; John Kyriopoulos, PhD Introduction/Study objectives: Generic medicines uptake is widely acknowledged as...

Author(s): Eleftheria Karampli, MSc, Estathia Triga, MSc, John Kyriopoulos, PhD, Kostas Athanasakis, PhD, Vasiliki Tsiantou, MSc

generics, medicines consumption, patients, pharmaceutical policy, physicians, prescribing

DOI: 10.5639/gabij.2016.0501.005

16.058 views

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Regulatory

Published on 11 September 2015

Regulatory requirements for the development and registration of biosimilars in South Africa

Abstract: In South Africa, medicines are registered and regulated in terms of the Medicines and Related Substances Control Act (Act 101 of 1965), as amended, and the regulations to this...

Author(s): Khamusi Philip Mutoti, BSc, BPharm Sci, Professor Nontombe Mbelle, MChB, MMed, FC Path (CMSA), Henry MJ Leng, PhD

biosimilars, comparative studies, registration requirements

DOI: 10.5639/gabij.2015.0403.033

15.985 views

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Original Research

Published on 31 March 2017

Do pricing and usage-enhancing policies differ between biosimilars and generics? Findings from an international survey

Introduction/Study objective: This paper aims to survey the policies implemented by European countries for pricing and promoting the use of biosimilar medicines and to explore similarities and differences with policies...

Author(s): Peter Schneider, MA, Sabine Vogler, PhD

biosimilar, generics, policy, pricing, substitution, tender

DOI: 10.5639/gabij.2017.0602.015

15.862 views

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Review Article

Published on 26 October 2016

Cost-minimization analysis of generic equivalents (bortezomib, decitabine and capecitabine) in comparison to the originator brand medicines in Colombia

Author byline as per print journal: Shyam Akku, MD; Amit Garg, MD; Suhas Khandarkar, MPharm Introduction: Majority of the Colombian population has become health insured leading to improved healthcare access in...

Author(s): Amit Garg, MD, Shyam Akku, MD, Suhas Khandarkar, MPharm

anticancer drugs, cost-minimization, generics, pharmacoeconomics

DOI: 10.5639/gabij.2016.0504.042

15.781 views

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Letters to the Editor

Published on 12 November 2012

The ethics of biosimilars

Abstract:  Comment on the Letters to the Editor by Dr Carlo Petrini: A bioethicist’s view of the use of biosimilars, published in GaBI Journal, 2012, issue 3-4. Submitted: 9 November 2012; Revised: 12...

Author(s): Christian K Schneider, MD

DOI: 10.5639/gabij.2013.0201.001

15.722 views

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Guidelines

Published on 06 September 2017

Biosimilars in Germany: guidance of the Drug Commission of the German Medical Association

Abstract: Biosimilars have been available in Europe for more than 10 years, but their adoption in Germany has not been very successful. As their pharmaceutical quality, efficacy (particularly in extrapolated...

Author(s): Professor Wolf-Dieter Ludwig, PhD, Stanislava Dicheva, PhD

biologicals, biosimilars, Germany, guidance, switching

DOI: 10.5639/gabij.2017.0604.037

15.637 views

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Original Research

Published on 10 February 2018

Analysis of Drug Master Files registered in Japan: aiming for a stable supply of active pharmaceutical ingredients

Introduction/Study objectives: A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). API manufacturers generally register API information as a Drug...

Author(s): Maki Matsuhama, MSc, Ryosuke Kuribayashi, PhD

active pharmaceutical ingredients, Drug Master File, generic drugs, globalization, stable supply

DOI: 10.5639/gabij.2018.0701.003

15.532 views

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Regulatory

Published on 09 February 2016

Pricing of biosimilars in Saudi Arabia

Author byline as per print journal: Ali M Alhomaidan, PhD; Ibrahim A Aljuffali, MSc, PhD; Fahad S Alnutaifi, MHEcon, MPH; Nasseruddeen A AL-Howaimel, MSc Abstract: Innovation in the pharmaceutical industry...

Author(s): Ali M Alhomaidan, PhD, Fahad S Alnutaifi, MHEcon, MPH, Ibrahim A Aljuffali, MSc,PhD, Nasseruddeen A AL-Howaimel, MSc

biosimilar, prices, Saudi Arabia

DOI: 10.5639/gabij.2016.0501.007

15.194 views

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Commentary

Published on 02 June 2015

The challenges of nomenclature – INN, biosimilars and biological qualifiers

Abstract: A novel global and company specific biological qualifier, distinct from the International Nonproprietary Name (INN), is proposed by World Health Organization (WHO) for all biological active substances. Submitted: 14...

Author(s): James S Robertson, PhD

biological active substances, Biological Qualifier (BQ), biosimilars, international non-proprietary names

DOI: 10.5639/gabij.2015.0403.025

15.127 views

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Abstracted Scientific Content

Published on 29 May 2019

Regulatory requirements for the acceptance of foreign comparator products in the participants of the International Generic Drug Regulators Programme

Submitted: 4 March 2019; Revised: 25 April 2019; Accepted: 27 April 2019; Published online first: 30 April 2019 The availability of quality generic drug products plays an increasingly important role...

Author(s): Alfredo García Arieta, PhD

DOI: 10.5639/gabij.2019.0801.005

15.070 views

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