Search results with tag "Locally acting"
Guideline on clinical development of fixed combination ...
www.ema.europa.euexposure, the CHMP guidance on locally applied locally acting products containing known constituents should be followed. Clinical data requirements : For each of the three therapeutic scenarios the appropriate clinical requirements are described in the sections 4.1, 4.2 and 4.3, respectively. The clinical data should demonstrate a favourable ...
Draft Note Guidance Investigation Bioavailability ...
www.ema.europa.eu33 • Clinical Requirements for Locally Applied, Locally Acting Products Containing 34 Known Constituents. 35 • The Investigation of Drug Interactions 36 • Development Pharmaceutics 37 • Process Validation 38 • Manufacture of the Finished Dosage Form 39 • Validation of analytical procedures: Definitions and Terminology (ICH topic Q2A)
Topical Drug Products Regulatory Requirements …
www.ipapharma.orgLocally Acting Drug Products Methods for determining BE • Methods for BE (identified in 21 CFR 320.24) – Pharmacokinetic study – Pharmacodynamic study