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4 The definition has since evolved and expanded to include molecular signatures of pharmacodynamics and therapeutic response. As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms.
The committee also made recommendations regarding pharmacokinetic and safety assessments. FDA’s clinicalpharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. Once metabolized, which occurs quickly with a half-life of approximately 1.5
While the previous version stated that patients with kidney or liver dysfunction should be enrolled as long as the pharmacokinetics (PK) for the drug in such patients is “adequately understood,” the new guidance is phrased to indicate that, moving forward, the PK in these patients should be understood.
Older adults: While certain age-associated factors like comorbidities, age, and weight can be adjusted using standard clinicalpharmacology methods; reviewers have noted that these factors do not entirely adjust for the differences we see in older patient populations.
Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.
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