Newsletter | August 3, 2020

08.03.20 -- Considerations In Drug Development: Reduce Cost, Improve Success Rate, And Shorten Time To Market

Optimize Chemical Synthesis, Formulation In Complex Molecule Development

Finding a balance between a complex API, its formulation, and its synthesis requires equipment, knowledge, and processes more extensive than those typically required for traditional drug development. 

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions

Developed by the FDA, the Biopharmaceutics Classification System (BCS) helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability.

What’s The Best Path For Your Low Soluble Molecule?

A tale of two molecules, both designed to treat the same condition, both with solubility challenges. Two biopharma companies racing to be first. Who gets to market first may surprise you.

Manufacturing Process Scale-Up For Phase III
Critical make-or-break Phase III studies are on the horizon to demonstrate safety and efficacy in large numbers of patients. Is your team ready to manufacture larger batch sizes to support this endeavor? Possibly.