The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development

Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics (PBPK/PBBM) emerged as particularly useful tool formulation development. PBPK/PBBM facilitated strategies increasingly evaluated over the past few years, demonstrated by several reports from pharmaceutical industry, and number research review papers on this subject. Also, leading regulatory authorities recently issued guidance use PBPK design. In silico models can comprise dosing routes (oral, intraoral, parenteral, inhalation, ocular, dermal etc.), although majority published examples refer to oral drugs performance. order facilitate tools, couple companies launched commercially available software such GastroPlus™, Simcyp™ Simulator PK-Sim®. This paper highlights various application modeling, along with basic principles, advantages limitations approach, provides relevant demonstrate practical utility stages