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

Author byline as per print journal: Professor Wolf-Dieter Ludwig, PhD; Stanislava Dicheva, PhD Abstract: Biosimilars have been available in Europe for more than 10 years, but their adoption in Germany has… 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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