Month: June 2015
Simcyp In Vitro (Data) Analysis (SIVA) Toolkit: Deciphering Dissolution Experiments and Translating Intrinsic Parameters into PBPK Models
A New Method to Quantify Population Variability for Toxicity Testing
Historically, toxicity testing has been conducted by giving lab animals high doses of chemicals and observing them for adverse events. But quantifying the risks chemicals pose to humans based on animal studies is problematic as the chemical doses are often orders of magnitude higher than environmental levels. Moreover, this process is slow, expensive, and ethically … Continued
Mapping In Vitro and In Vivo Derived CYP2C9 and CYP2C19 Ontogeny Functions: A Critical Comparison Between Various Ontogeny Models
Prediction of the Oral Clearance of Isoniazid in Virtual Subjects With Different Nat-2 Acetylator Status
Evaluation of the Drug-drug Interaction Between Zidovudine and Probenecid by Using a Mechanistic Kidney Model (Mech KiM) Nested Within a Full Physiologically-based Pharmacokinetic (PBPK) Model
Towards Quantitative Prediction of Disease-drug Interactions Using a Physiologically-based Pharmacokinetic Modeling Approach: Suppression of CYP1A2 by IL-6
Application of a Multi-compartment Permeability Limited Lung Model to Predict Lung Concentrations of Anti-Tuberculosis Drugs in Virtual Human Subjects
Q&A – Ad Promo Submissions
Editor’s Note: Below are responses to the questions submitted by members of industry during GlobalSubmit’s Module 1 Education Series – M1 Effect on Ad Promo Submissions Webinar on June 16, 2015. 1. Now that industry is able to submit OPDP submissions in eCTD format, can you foresee any issues/challenges when a sponsor and a partner … Continued
Gaining FDA Support for a Prognostic Biomarker, Giving Patients Hope
As a clinician scientist, I get really excited about helping sponsors develop new treatments for patients. For some diseases, the lack of a validated prognostic biomarker is an impediment to developing effective treatments. In this blog post, I’ll discuss how we worked with the Critical Path Institute (C-Path) Polycystic Kidney Disease Outcomes Consortium to gain … Continued