Practical Strategies for Developing Preclinical and Phase I Oral Drug Formulations 2014

Topics

• Preclinical animal species considerations for testing formulations, including allometric scaling for estimating exposure in humans
• Solubilization approaches used for poorly soluble pharmaceutical compounds
• Bioenhanced formulation strategies for phase 1 capsules and tablets, including particle size reduction techniques, solid dispersions and liquid-filled capsules
• Strategies and major issues to consider in oral dosage form development for phase 1, including lab and pilot scale processing factors, excipient compatibility for capsules and tablets, common problems encountered and problem solving approaches
• Formal stability assessment of solid oral dosage forms for phase 1, including common problems encountered and problem solving approaches

Who should Attend

Technical managers and scientists involved in early drug development responsible for preclinical and/or phase 1 clinical formulations.