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Explore how PBPK models combined with custom and off-the shelf in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development, reducing the need for drug product reformulation or repeated preclinical or clinical studies and helping to save time, money, and resources.
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We discuss the role of solid form services in helping meet the accelerated timelines of the drug development lifecycle and share examples of robust workflows for fast and thorough solid form screens. A case study reviews the polymorph screen of a late-stage API focusing on monotropic vs enantiotropic polymorphs.
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Which technical issues need to be addressed if an API is to be successfully micronized? Review a robust process development strategy that ensures all attributes critical for quality are maintained. Explore a case study on the micronization of a highly potent inhaled API with a tendency to undergo surface amorphization.
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The efficient development of robust oral drug products requires biopredictive in vitro dissolution methods that can evaluate how the interplay between the drug formulation and the properties of the gastrointestinal fluid impacts on performance. Learn about the design of dissolution media to support biopredictive dissolution testing.
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A growing number of drugs in the development pipeline are poorly soluble in gastrointestinal fluids and can severely limit oral bioavailability. This talk describes how an amorphous solid dispersion (ASD) of acalabrutinib was designed using in vitro studies and in silico modeling. Understand how ASD formulations can enhance bioavailability.
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