Why Do New Therapies Succeed Or Fail In The Marketplace?
How can decisions made during the preclinical phase of drug development increase the chances of a product’s eventual success in a difficult marketplace?
Elemental Impurities- Guidelines, Testing And Assessments
This eBook published by Pharmaceutical Technology provides an overview of the regulatory landscape related to elemental impurities testing, discusses the challenges of implementing ICH Q3D guidelines …
Extractables & Leachables: Understanding Container and Device Interactions
Summary: It is vital that drug products reach patients uncontaminated and unadulterated by their packaging. Extractables and leachables (E&L) are especially of concern for liquid injectable…
PBPK Modeling and Other Strategies for Early Phase Success
Leveraging knowledge about an API’s physiochemical properties from preformulation and formulation studies increases the chances of early-phase success.
Next Generation of Small Molecule Oral Drugs
A connected, data-driven approach to managing bioavailability challenges in new chemical entities