TY - JOUR
T1 - Quality and equivalence of topical products
T2 - A critical appraisal
AU - Miranda, Margarida
AU - Cardoso, Catarina
AU - Vitorino, Carla
N1 - Publisher Copyright:
© 2019 Elsevier B.V.
PY - 2020/5/30
Y1 - 2020/5/30
N2 - The approval of topical generic products is essentially governed by clinical endpoint studies. Is this the most efficient approach to document bioequivalence in these particular dosage forms? This issue has sparked multiple discussions among different stakeholders – academia, industry and several regulatory agencies – in the active pursuit for new and robust surrogate methodologies. This mini review attempts to critically discuss this topic in light of the recently issued European regulatory requirements within the proposed modular framework for bioequivalence assessment.
AB - The approval of topical generic products is essentially governed by clinical endpoint studies. Is this the most efficient approach to document bioequivalence in these particular dosage forms? This issue has sparked multiple discussions among different stakeholders – academia, industry and several regulatory agencies – in the active pursuit for new and robust surrogate methodologies. This mini review attempts to critically discuss this topic in light of the recently issued European regulatory requirements within the proposed modular framework for bioequivalence assessment.
KW - Bioequivalence
KW - EMA guideline
KW - Extended pharmaceutical equivalence
KW - Generic topical products
UR - http://www.scopus.com/inward/record.url?scp=85082837144&partnerID=8YFLogxK
U2 - 10.1016/j.ejps.2019.105082
DO - 10.1016/j.ejps.2019.105082
M3 - Review article
C2 - 31626969
AN - SCOPUS:85082837144
SN - 0928-0987
VL - 148
JO - European Journal of Pharmaceutical Sciences
JF - European Journal of Pharmaceutical Sciences
M1 - 105082
ER -