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

Published in: Volume 6 / Year 2017 / Issue 4
Author(s): ,
Page: 178-80

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… Read More »

New product-specific bioequivalence guidance

Published in: Volume 3 / Year 2014 / Issue 1
Page: 29

Abstract: For harmonization of the authorization requirements for specific generic applications within the EU, consistent criteria were drafted for 16 active substances, which are out now for public consultation. Submitted:… Read More »

Update on clinical practice guideline on the use of epoetin and darbepoetin in adult patients with cancer

Published in: Volume 2 / Year 2013 / Issue 2
Page: 97-8

Abstract: Chemotherapy-induced anaemia can be treated using erythropoiesis-stimulating agents (ESAs), but these can cause serious side-effects including tumour progression, venous thromboembolism, and shorter survival. Following extensive review of recent literature,… Read More »

EORTC continues to support the appropriate treatment of adult patients with G-CSF to prevent febrile neutropenia: guideline updates

Published in: Volume 2 / Year 2013 / Issue 1
Page: 47-8

Abstract:  The European Organisation for Research and Treatment of Cancer (EORTC) has updated its 2006 guideline on the use of granulocyte colony-stimulating factor (G-CSF) for the prevention of febrile neutropenia… Read More »

New CHMP guideline on immunogenicity of monoclonal antibodies

Published in: Volume 2 / Year 2013 / Issue 1
Author(s): ,
Page: 45-6

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: The importance of monoclonal antibodies as a product class and the challenge of assessing unwanted immunogenicity… Read More »

ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities

Published in: Volume 1 / Year 2012 / Issue 3-4
Author(s): ,
Page: 142-4

Abstract:  The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scientific and technical… Read More »

Generics substitution in primary care: summary of the Dutch community pharmacies guidelines

Published in: Volume 1 / Year 2012 / Issue 2
Author(s): ,
Page: 102-3

Abstract:  Marketed medicines that have passed bioequivalence testing should in general be substitutable. However, for a variety of reasons, caution may be warranted, particularly with regard to narrow therapeutic index… Read More »

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