Cognitive Engineering – The Tools, Mindset, and Strategy for an Integrated Development Standard

Cognitive Engineering – The Tools, Mindset, and Strategy for an Integrated Development Standard

Authors: Grasela TH
Conference: ASCPT

Internet technology facilitates connectedness but often fails to foster collaboration. Advanced modeling techniques can provide insight for development discussions, but in many cases, these tools…

Pharmacokinetic Analysis of Gatilfoxacin in Plasma and Sinus Aspirate Drug Treatment of Maxiliary Sinusitis

Pharmacokinetic Analysis of Gatilfoxacin in Plasma and Sinus Aspirate Drug Treatment of Maxiliary Sinusitis

Conference: AAPS

A novel approach to collect sinus exudate was utilized and the time course of gatifloxacin (GAT) in the blood and at the primary infection site were assessed during treatment for acute maxillary sinusitis (AMS).

A framework for 2-stage global sensitivity analysis of GastroPlus™ compartmental models

A framework for 2-stage global sensitivity analysis of GastroPlus™ compartmental models

Publication: J Pharmacokinet Pharmacodyn
Software: GastroPlus®

Parameter sensitivity and uncertainty analysis for physiologically based pharmacokinetic (PBPK) models are becoming an important consideration for regulatory submissions, requiring further...

Food effects in paediatric medicines development for products Co-administered with food

Food effects in paediatric medicines development for products Co-administered with food

Publication: Int J Pharm
Software: GastroPlus®
Division: PBPK

A small amount of food is commonly used to aid administration of medicines to children to improve palatability and/or swallowability.

Pharmacokinetics And Exposure-Response Relationships Of Dasotraline In The Treatment Of Attention-Deficit/Hyperactivity Disorder In Adults

Pharmacokinetics And Exposure-Response Relationships Of Dasotraline In The Treatment Of Attention-Deficit/Hyperactivity Disorder In Adults

Conference: ACoP

To characterize the pharmacokinetic and pharmacodynamic data to explore the time course and exposure response relationships in Phase 2 to define dasotraline benefit to risk relationship in adult Attention...

Characterization of Population Pharmacokinetics of Cariprazine and Its Major Metabolites

Characterization of Population Pharmacokinetics of Cariprazine and Its Major Metabolites

Conference: American Psychiatric Association (APA)

Population pharmacokinetic (PK) analysis was undertaken to describe the concentration‑time profiles of cariprazine and its 2 major metabolites of similar pharmacological activity, desmethyl‑cariprazine...

Phase I study of the investigational oral mTORC1/2 inhibitor sapanisertib (TAK-228): tolerability and food effects of a milled formulation in patients with advanced solid tumours

Phase I study of the investigational oral mTORC1/2 inhibitor sapanisertib (TAK-228): tolerability and food effects of a milled formulation in patients with advanced solid tumours

Publication: ESMO Open
Software: GastroPlus®

Sapanisertib (TAK-228) is an investigational, orally available, potent and highly selective mTORC1/2 inhibitor demonstrating promise in numerous malignancies.

Physiologically-Based Pharmacokinetic Modeling in Lead Optimization II: “Rational Bioavailability Design” by Global Sensitivity Analysis to Identify Properties Affecting Bioavailability.

Physiologically-Based Pharmacokinetic Modeling in Lead Optimization II: “Rational Bioavailability Design” by Global Sensitivity Analysis to Identify Properties Affecting Bioavailability.

Publication: Mol Pharm
Division: PBPK

When medicinal chemists need to improve oral bioavailability (%F) during lead optimization, they systematically modify compound properties mainly based on their own experience and general rules of thumb.

Physiologically-Based Pharmacokinetic Modeling in Lead Optimization I: Evaluation and Adaptation of GastroPlus to Predict Bioavailability of Medchem Series

Physiologically-Based Pharmacokinetic Modeling in Lead Optimization I: Evaluation and Adaptation of GastroPlus to Predict Bioavailability of Medchem Series

Publication: Mol Pharm
Division: PBPK

When medicinal chemists need to improve bioavailability (%F) within a chemical series during lead optimization, they synthesize new series members with systematically modified properties...

Preparation and Evaluation of Progesterone Nanocrystals to Decrease Muscle Irritation and Improve Bioavailability.

Preparation and Evaluation of Progesterone Nanocrystals to Decrease Muscle Irritation and Improve Bioavailability.

Publication: AAPS PharmSciTech
Software: GastroPlus®

Progesterone (PG) is a crucial immunomodulatory agent during early pregnancy, and nowadays PG oil-based injection (PG/OI) has a huge market all over the world.