Clinical Pharmacology Disease Pharmacokinetics 
ASPET
MAY 22, 2024
Yet, the absence of established systemic and brain pharmacokinetic (PK) parameters at relevant pre-clinical doses presents a significant knowledge gap. Intravenous (IV) bolus administration of metformin to C57BL6 mice covered low to high dose range maintaining pharmacological relevance.
Drug Target Review
APRIL 7, 2025
As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. 2 This progress has implications for diagnosis, therapeutic efficacy, and potentially establishing clinically relevant endpoints.
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Alta Sciences
OCTOBER 30, 2023
36: Nonclinical Studies in Cell and Gene Therapy – Key Considerations and Regulatory Guidance With an estimated 6,000 monogenic diseases affecting over 350 million people worldwide, the advantages of cell and gene therapy can be a ray of hope—but development of complex, leading-edge therapies requires careful planning. Read it now.
New Drug Approvals
SEPTEMBER 13, 2024
2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]
Agency IQ
SEPTEMBER 15, 2023
The committee also made recommendations regarding pharmacokinetic and safety assessments. FDA’s clinical pharmacology 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
Agency IQ
FEBRUARY 23, 2024
I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology. Then, a bit later but still in early-phase studies, developers can leverage this pharmacology information in innovative approaches that may incorporate modeling.
Agency IQ
JULY 28, 2023
The Centers for Disease Control and Prevention (CDC) explains that the first wave began with increased prescription of opioids in the 1990s. This proposal is an exciting example of how new approaches at the forefront of clinical pharmacology can be leveraged to address the problems being discussed in other forums (e.g.,
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