Newsletter | June 24, 2020

06.24.20 -- Optimizing API In Drug Development

Critical API Attributes And The Major Impact They Can Have On Drug Product Development

It is well known that the physical properties of an API are important in selecting the dosage form and designing its formulation to meet the drug product requirements. An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.

Six API Challenges And How To Avoid Them

The challenges for new drugs looking to enter the market are numerous and varied. But many are self-inflicted — especially in small molecule development. A dangerous perception persists that, aside from highly potent APIs, small molecule medications have simple process requirements. Having a solid understanding of the most common API challenges can help to avoid development delays, rework, or outright failure.

Accelerate Complex Molecule Development By Optimizing Chemical Synthesis And Formulation

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. It also calls for collaboration across several teams in order to break down the silos that can interrupt the flow of open and clear communication.

8 Criteria For A More Successful API Partnership

Save time and money by addressing these eight critical areas that are required for a fast, smooth API development process.