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Physiologically based pharmacokinetic (PBPK) studies can be conducted on rapid timelines with minimal amounts of API. The findings help drug sponsors make informed decisions about the priorities of their early drug development process, gain improved context for understanding poor absorption, and implement risk mitigation strategies from the outset.
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Early identification of an API's lead solid form is essential since this upfront work minimizes risk in crystallization development, streamlines process scale-up, and protects critical development timelines. A Lonza expert addresses attendee questions on how to nominate a lead form, when to utilize a salt screen, and other solid form strategies.
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Dive into the role of solid form services in helping meet the accelerated timelines of the drug development lifecycle with examples of robust workflows for fast and thorough solid form screens. Review the polymorph screen of a late-stage API focusing on monotropic vs enantiotropic polymorphs and the crystallization process development.
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Solid form screening encompasses the search, preparation, and characterization necessary to identify, isolate, and ensure confidence in the stability and downstream manufacturability of a lead form. In many ways, this process serves as the bridge between drug substance and drug product for new chemical entities.
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If you want to identify possible absorption risks for your preclinical or clinical studies as early as possible, consider leveraging physiologically based pharmacokinetic (PBPK) modeling to simulate how your drug is distributed and eliminated around the body. PBPK is validated to support dose selection and study design for FIH trials.
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