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Clinical Pharmacology & Model-Informed Development Organize clinical pharmacology and modeling around exposure, response, and dose decisions. Which evidence and assumptions support dose selection? How should uncertainty in exposure–response analyses be assessed? When should population PK, PBPK, or Q…
Clinical Pharmacology & Model-Informed Development
A study in European Journal of Drug Metabolism and Pharmacokinetics modeled subcutaneous aqueous progesterone using single-dose crossover data from 50 healthy Chinese postmenopausal women. Machine-learning approaches screened potential covariates before conventional PopPK evaluation. Height and body-weight effects remained statistically identifiable but had limited clinical significance. Simulated repeated-dose exposure is model-derived, rather than an observed efficacy outcome in fertility patients.