Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

Doctors and Scientists

GastroPlus™

The formulation and PK experts at PharmaDirections use a variety of software packages that allow them to develop formulations and products that are sure to meet their physiological goals. The use of GastroPlus™ allows them unprecedented approaches to understanding the disposition and delivery of orally or nasally delivered drugs.

  • PharmaDirections licenses GastoPlus™ from Simulations Plus for use in our drug discovery and formulation development projects
  • Advanced software program that simulates absorption, pharmacokinetics, and pharmacodynamics in animals and in humans
  • Whole-body physiological models for human (fasted and fed), beagle dog (fasted and fed), rat (fasted and fed), mouse (fasted and fed), and cyno monkey
  • Dosage forms: IV, solid oral (immediate and controlled release), liquid, buccal, sublingual pH-dependent solubility and logD models
  • Mechanistic effect of bile salts on in vivo drug solubility and dissolution
  • Enhanced treatment of nanoparticle effects on solubility and dissolution
  • Dissolution and precipitation dependence on particle size, shape and particle density
  • Chemical degradation of drug in intestinal lumen prior to absorption
  • Virtual Trials - predict likely population distributions of PK/PD results