Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union
The development of second-entry topical products is hampered by several factors. The excipient composition should be similar to the reference product because excipients may also contribute to efficacy. Conventional pharmacokinetic bioequivalence studies were not considered acceptable because drug co...
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MDPI AG,
2023-02-01T00:00:00Z.
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