Semi-Mechanistic PK/PD Model Effect Odanacatib, a Cathespin K Inhibtor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women
Keywords: Cathepsin K Inhibitor, lumbar spine bone, Odanacatib, ODN treatment, Phase II, PK/PD model, postmenopausal women, SLP MIDD+ Virtual Conference, SLP2021MIDDConference: SLP MIDD+Division: Cognigen
David Jaworowicz, Senior Director of Pharmacokinetics/Pharmacodynamics, presents objectives, study design, and data analysis for the semi-mechanistic PK/PD model of the effect of Odanacatib in Phase II studies of postmenopausal women.
Topics covered:
- Development of a semi-mechanistic population PK/PD model to simultaneously characterize the time course of the bone resorption biomarker uNTx (urinary amino-terminal cross-linked telopeptides of Type 1 collagen) and the corresponding lumbar spine BMD response following long-term once-weekly ODN treatment
- Exposure-response profiles for Osteoclast cycling and bone resorption and corresponding Osteoclast profiles
- and more!
Presented at SLP MIDD+ Virtual Conference March 3-4, 2021
