Published on 20 January 2014
New product-specific bioequivalence guidance
Author(s): Christoph Baumgärtel, MD, MSc
authorization, bioequivalence, generics, product-specific bioequivalence guidance
DOI: 10.5639/gabij.2014.0301.009
12.070 views
Published on 20 January 2014
Author(s): Christoph Baumgärtel, MD, MSc
authorization, bioequivalence, generics, product-specific bioequivalence guidance
DOI: 10.5639/gabij.2014.0301.009
12.070 views
Published on 16 December 2013
Author(s): Austin J Combest, PharmD, MBA, Song Wang, PhD, Brian T Healey, PharmD, MS, MBA, RAC, Dirk J Reitsma, MD
Bayesian design, biosimilar, drug development, repeated measures analysis, statistics strategy
DOI: 10.5639/gabij.2014.0301.006
17.235 views
Published on 12 December 2013
Author(s): GaBI Journal Editor
DOI: 10.5639/gabij.2014.0301.013
6.562 views
Published on 05 December 2013
Author(s): Professor Philip D Walson, MD
DOI: 10.5639/gabij.2013.0204.042
11.610 views
Published on 04 December 2013
Author(s): GaBI Journal Editor
DOI: 10.5639/gabij.2013.0203.041
8.951 views
Published on 04 December 2013
Author(s): Armando A Genazzani, DPhil, MD, Nicola Magrini, MD
alternative therapeutic products, biosimilar, essential medicines, peginterferon, regulatory approval pathways, World Health Organization (WHO)
DOI: 10.5639/gabij.2013.0204.044
20.837 views
Published on 27 November 2013
Author(s): Edward T Maggio, PhD
immunogenicity, INN, neoantigen, neutralizing antibodies, oxidative damage, polysorbate, protein aggregation
DOI: 10.5639/gabij.2013.0204.046
6.343 views
Published on 18 November 2013
Author(s): Beat Flühmann, PhD, Professor Philip D Walson, MD, Professor Stefan Mühlebach, PhD
follow-on drugs, nanomedicines, non-biological complex drug (NBCD), regulatory practice
DOI: 10.5639/gabij.2014.0301.010
14.207 views
Published on 18 November 2013
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
16.477 views
Published on 18 November 2013
Author(s): Andrea Devaney
generics substitution, immunosuoppressives, self-medication, tacrolimus, transplantation
DOI: 10.5639/gabij.2014.0302.023
26.148 views
Published on 12 November 2013
Author(s): Brendan Shaw, PhD
DOI: 10.5639/gabij.2013.0204.048
8.966 views
Published on 29 October 2013
Author(s): Janet S Wyatt, RN, PhD, FAANP
DOI: 10.5639/gabij.2013.0204.045
6.581 views