Variation of topical application to skin under good clinical practice (GCP): A “best performance” scenario

Abstract

There was a major variation of test ointment application studied under GCP conditions with adherent participants. In dermatological practice, the variation is assumed to be even higher. This should be taken into account in clinical trials, especially dose-finding studies typically operating with 3-5-fold increments.

Multi-component Chinese medicine formulas for drug discovery: State of the art and future perspectives

“…This understanding may greatly accelerate the internationalization and modernization of Chinese medicine, if the underlying mechanisms are scientifically determined. 4) Clinical trials should follow SOPs whose rules are well accepted worldwide (e.g., ICH-GCP) [154]. 5) Better understanding of the policies for the approval of new drugs in various areas (US, China, and the European Union) is a prerequisite for the successful approval of novel drug applications (Table 3).…”

Use of topical antipsoriatic drugs in Denmark: a nationwide drug utilization study

“…The large heterogeneity in how patients use topical drugs does not allow for conclusions regarding adherence; many patients with psoriasis with limited disease may use the same topical drug container for extended periods of time, so drug survival curves (where patients who did not redeem a new prescription within 6 or 12 months are considered nonadherent) must be interpreted with caution . Consequently we refrained from providing a more exact estimate of adherence to topical antipsoriatic drugs.…”