Critical API Attributes and the Major Impact They Can Have on Drug Product Development
Small molecule drug substance development is often completed without consideration for the final drug product formulation. To some extent this is necessary, as drug substance must be generated before any product development activities can commence. However, both activities are intimately linked by the final purification and isolation step of the chemical synthesis and manufacturing process.
Read this whitepaper to discover why an alternative, integrated approach to formulation should be considered based on the impact of certain API properties on the final drug product.