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CFT8919 is an orally bioavailable BiDAC degrader designed to exhibit potent and selective activity against EGFR L858R in patients with non-small cell lung cancer (NSCLC). Betta will be responsible for the development, manufacture and commercialisation of CFT8919 in the licensed territories.
Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. Approaches to Pharmacokinetic Analysis.
In addition to prioritizing programs most closely aligned with sponsor objectives, a portfolio analysis can help prevent a program from failing due to misalignment of the various factors that affect drug development, including clinical, nonclinical, regulatory, scientific, manufacturing, and market dynamics. Clinical Pharmacology.
Best practice is to also consider the ‘developability’ of the lead compounds in conjunction with any evidence of potential in-vivo activity, by taking a holistic approach. With all this in mind, how do drug developers know which strategy and approach is right for their molecule at this early stage?
The drug development process can be broken down into three main disciplines: chemistry, manufacturing, and control (CMC); nonclinical; and clinical. CMC programs include drug substance manufacturing process scale-up, stability testing, early formulation development, and, later on, manufacturing process validation, among other considerations.
How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably. Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products.
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