Critical API Attributes and the Major Impact They Can Have on Drug Product Development

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Overview

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.

Key Objectivesï¼š

Impact of API properties on formulation
Impact of particle size
The importance of an integrated drug development approach

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