Development of a guideline on quality and equivalence of topical products

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Concept paper

Reference numberEMA/CHMP/QWP/558185/2014
Published22/04/2015
KeywordsTherapeutic equivalence, bioequivalence, pharmaceutical equivalence, generic and hybrid medicinal products, locally applied, locally acting products, topical products, dermatological use, in vitro, quality
DescriptionThis document adresses the need for guidance on the quality requirements of topical products containing new or known active substance. The proposed guideline will develop a systematic approach to describe methods for the prediction of therapeutic equivalence, when taken with evidence of extended pharmaceutical equivalence.


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