Definition Drug Development Pharmacokinetics 
Drug Target Review
JULY 21, 2025
However, the advanced nature of the drugs being developed has brought new challenges. Current challenges in CNS drug development Drug development for the CNS is particularly challenging and researchers face several hurdles to producing effective and safe treatments, many of which are unique to the CNS.
Drug Target Review
APRIL 7, 2025
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.
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FDA Law Blog: Drug Discovery
FEBRUARY 2, 2023
While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).
Alta Sciences
SEPTEMBER 13, 2023
COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. At Altasciences , we have extensive experience testing various pain models.
Agency IQ
MAY 17, 2024
How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,
Agency IQ
FEBRUARY 12, 2024
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.
Agency IQ
SEPTEMBER 22, 2023
The Heckler case helped to refine the definition of “substantial evidence” in two important ways. First, the court determined that the determination of what constituted “substantial evidence” was within the purview of the FDA, to ensure a drug was “therapeutically significant rather than merely statistically significant.”
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