Pilot and Repeat Trials as Development Tools Associated with Demonstration of Bioequivalence
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 3
Abstract
The online version of this article (doi:10.1208/s12248-015-9744-6) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Anders Fuglsang
Guidelines for the Quality Control of Population Pharmacokinetic–Pharmacodynamic Analyses: an Industry Perspective
Quality population modeling and simulation analyses and reports are something every modeler desires. However, little attention in the literature has been paid to what constitutes quality regarding population analyses. Ve...
Performance of Three Estimation Methods in Repeated Time-to-Event Modeling
It is not uncommon that the outcome measurements, symptoms or side effects, of a clinical trial belong to the family of event type data, e.g., bleeding episodes or emesis events. Event data is often low in information co...
Evaluation of Agile Designs in First-in-Human (FIH) Trials—A Simulation Study
The online version of this article (doi:10.1208/s12248-009-9141-0) contains supplementary material, which is available to authorized users.
What is the Likelihood of an Active Compound to Be Promiscuous? Systematic Assessment of Compound Promiscuity on the Basis of PubChem Confirmatory Bioassay Data
Compound promiscuity refers to the ability of small molecules to specifically interact with multiple targets, which represents the origin of polypharmacology. Promiscuity is thought to be a widespread characteristic of p...
Optimization of chlorphenesin emulgel formulation
This study was conducted to develop an emulgel formulation of chlorphenesin (CHL) using 2 types of gelling agents: hydroxypropylmethyl cellulose (HPMC) and Carbopol 934. The influence of the type of the gelling agent and...