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

Authors: Cirincione B, Passarell JA, Cummings M, Ludwig E, Grasela TH, Halseth A, Fineman MS
Conference: ASCPT
Keywords: anti-obesity, BMI, body mass index, Endocrinology, lifestyle intervention, obese, PK/PD, PKPD methodology, placebo, time course, time-dependent, weight, weight loss
Division: Cognigen

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

Authors: Fineman MS, Phillips L, Jaworowicz DJ, Cirincione B, Ludwig E, Taylor K, Kothare PA, Baron A, Grasela TH
Conference: ASCPT
Keywords: antibody, antidiabetic, antidiabetic agents, dose selection, drug development process, Endocrinology, exendin, exposure-response, fixed dosing, gender, geometric mean ratio, glucose, hormones, learn-confirm, NONMEM, PK, PK/PD, titer, weight
Division: Cognigen

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

Authors: Cirincione B, Redman M, Fiedler-Kelly J, Ludwig E, Vermeulen A
Conference: ASCPT
Keywords: antipsychotic, CrCL, creatinine clearance, extended release, intravenous, IV, lag time, LBM, lean body mass, NONMEM, oral, OROS, phenotype, PK, psychiatry, psychotherapeutic agents
Division: Cognigen

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

Authors: Grasela TH, Fiedler-Kelly J, Cirincione B, Hitchcock D, Reitz K, Sardella S, Smith B
Publication: AAPS J
Keywords: analysis, data assembly, data_assembly_and_programming, decision-making, forensic pharmacometrics, informatics, methods, models, pharmaceutical, pharmacokinetics, Technology, Theoretical
Division: Cognigen

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

Serial sinus aspirate samples during high-dose, short-course levofloxacin treatment of acute maxillary sinusitis

Serial sinus aspirate samples during high-dose, short-course levofloxacin treatment of acute maxillary sinusitis

Authors: Anon JB, Paglia M, Xiang J, Ambrose PG, Jones RN, Kahn JB
Publication: Diagn Microbiol Infect Dis
Keywords: Acute Disease, administration & dosage, adult, adverse effects, anti-bacterial agents, Catheters, Dose-Response Relationship, drug, drug administration schedule, drug effects, drug therapy, female, Haemophilus Infections, Haemophilus influenzae, Indwelling
Division: Cognigen

This study assessed daily aspirate samples from an indwelling sinus catheter during high-dose, short-course levofloxacin (750 mg daily x 5 days) treatment...

Pharmacodynamics of cefprozil against Haemophilus influenzae in an in vitro pharmacodynamic model

Pharmacodynamics of cefprozil against Haemophilus influenzae in an in vitro pharmacodynamic model

Authors: Smith PF, Tsuji B, Booker BM, Forrest A, Bajic S, Kelchlin P, Bhavnani SM, Jones RN, Ambrose PG
Publication: Diagn Microbiol Infect Dis
Keywords: anti-bacterial agents, cephalosporins, Dose-Response Relationship, drug, drug effects, drug therapy, growth & development, Haemophilus Infections, Haemophilus influenzae, humans, in vitro, methods, Microbial Sensitivity Tests, microbiology, otitis media
Division: Cognigen

An in vitro pharmacodynamic model was used to determine the pharmacokinetic-pharmacodynamic (PK-PD) measure and magnitude most strongly related...

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

Authors: Vermeulen A, Piotrovsky V, Ludwig EA
Publication: J Pharmacokinet Pharmacodyn
Keywords: Acute Disease, administration, administration & dosage, adult, aged, antipsychotic agents, Bipolar Disorder, blood, body mass index, body weight, Carbamazepine, computer simulation, Creatinine, Cytochrome P-450 CYP2D6, Databases as Topic, Drug Admini, oral
Division: Cognigen

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

Authors: Cvoro A, Paruthiyil S, Jones JO, Tzagarakis-Foster C, Clegg NJ, Tatomer D, Medina RT, Tagliaferri M, Schaufele F, Scanlan TS, Diamond MI, Cohen I, Leitman DC
Publication: Endocrinology
Keywords: ERbeta-selective ligands, menopausal symptoms, Novel estrogenic therapies
Division: Simulations Plus

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