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ERG’s mission is to provide the highest quality clinical trial execution across all clinical research phases to help sponsors.
A Patchwork of Patch Work: A Programmatic Approach to Evidence Generation
A sampling of 4 Phase 1 trials conducted at CPMI for one sponsor evaluating transdermal delivery systems (TDS) of 2 different generic investigational products.
Target Population
- Normal Healthy Volunteers
- 18-65 years old
- BMI: 19-30 kg/m2, inclusive
- Male and Female
2784
Adhesion Assessment with photos
424
Dermal response and Other Effects Scale with photos
360
Residual Assessments
Patch for Parkinson’s Disease
Single-dose studies assessed the bioequivalence, pharmacokinetics, and adhesion of the sponsor's generic XXXX TDS versus XXXX®, supporting U.S. generic registration and informing lead formulation selection for future pivotal trials.
Patch for Contraceptive
Single-dose studies compared adhesion performance of a generic contraceptive TDS across different lots following 7-day wear period to satisfy FDA requirements for post-marketing surveillance and to establish a favorable, "best-in-class" patch performance profile.
