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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. The reality, however, is that most APIs will require numerous steps or significant work upfront to avoid development delays, rework or outright failure.
One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline.
Authors:
Andreas Stolle, Vice President, Process Development Services, API
Peter Poechlauer, Ph.D., Innovation Manager, API
Bernt-Dietmar Schober, Senior Business Manager, CBP