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Radiopharmaceuticals-based-on-monoclonal-antibodies
[PDF, 50.25 KB]
About this guideline
Overseas effective date: January 1992
Replaces: Effective 6 January 2017: the quality aspects of this guideline have been replaced by the Guideline on development, production, characterisation and specification for monoclonal antibodies and related products (EMA/CHMP/BWP/532517/2008)
Categories: Quality | Specific types of products
TGA Annotations: Nil
- Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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For more information see International scientific guidelines adopted in Australia.