Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man
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Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man
Revision 1 of this appendix refers to the addition of point 6 – ‘The role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies’ (EMA/CHMP/151853/2014). All other content remains unchanged. For background information please see ‘Concept paper on the need to revise Condition – Specific guidance, Appendix 4 to the guideline on the evaluation of anticancer medic...
متن کاملCommittee for Medicinal Products for Human Use (chmp) Draft Guideline on the Evaluation of Anticancer Medicinal Products in Man
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Guideline on the evaluation of anticancer medicinal products in man
This guideline replaces guideline / NfG Reference.
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