Effect of Lifestyle Intervention on the Placebo Response in Anti-Obesity Trials: Considerations for Exposure-Response Modeling

Effect of Lifestyle Intervention on the Placebo Response in Anti-Obesity Trials: Considerations for Exposure-Response Modeling

Conference: ASCPT

Successful clinical development of anti-obesity agents is aided by characterization of the placebo effect, which can be significant when lifestyle intervention (LSI) accompanies pharmacologic therapy.

Model-Based Evaluations to Select and Confirm Doses in the Clinical Development of Exenatide

Model-Based Evaluations to Select and Confirm Doses in the Clinical Development of Exenatide

Conference: ASCPT

Population pharmacokinetic (PK) and pharmacodynamic (PK/PD) models based on early Phases 1 and 2 data for the new antidiabetic medication exenatide (ex) supported transition from weight-based to…

Population Pharmacokinetics of Paliperidone ER in Healthy Subjects and Patients With Schizophrenia

Population Pharmacokinetics of Paliperidone ER in Healthy Subjects and Patients With Schizophrenia

Conference: ASCPT

To develop a population pharmacokinetic (PPK) model for paliperidone extended-release (ER) and to evaluate the influence of selected covariates.

Informatics: the fuel for pharmacometric analysis

Informatics: the fuel for pharmacometric analysis

Publication: AAPS J

The current informal practice of pharmacometrics as a combination art and science makes it hard to appreciate the role that informatics can and should...

Population pharmacokinetics of risperidone and 9-hydroxyrisperidone in patients with acute episodes associated with bipolar I disorder

Population pharmacokinetics of risperidone and 9-hydroxyrisperidone in patients with acute episodes associated with bipolar I disorder

Publication: J Pharmacokinet Pharmacodyn

A population model was developed with the aim to simultaneously describe risperidone and 9-hydroxyrisperidone pharmacokinetics; to obtain estimates for pharmacokinetic parameters and associated...

Selective activation of estrogen receptor-beta transcriptional pathways by an herbal extract

Selective activation of estrogen receptor-beta transcriptional pathways by an herbal extract

Publication: Endocrinology
Division: PBPK

Novel estrogenic therapies are needed that ameliorate menopausal symptoms and have the bone-sparing effects of endogenous estrogens but do not promote breast or...