New Drug Approvals

SEPTEMBER 10, 2024

“A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of TAK-041 in healthy participants and patients with stable schizophrenia” British Journal of Clinical Pharmacology. . ^ Yin, Wei; Han, David; Khudyakov, Polyna; Behrje, Rhett; Posener, Joel; Laurenza, Antonio; Arkilo, Dimitrios (August 2022).

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The Premier Consulting Blog

SEPTEMBER 11, 2024

From a clinical pharmacology perspective, the sponsors also needed to establish a scientific bridge for relying on the data contained in the product labeling of the LD. This nonclinical study required good manufacturing practice (GMP) drug product, sham product, and vehicle to qualify the novel excipient used to modify absorption.

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New Drug Approvals

APRIL 19, 2025

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. PMID 27092187. Atarashi H, Kuruma A, Yashima M, Saitoh H, Ino T, Endoh Y, et al. August 2000). 68 (2): 14350. doi : 10.1067/mcp.2000.108733. 2000.108733.

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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]

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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

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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. . …

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Alta Sciences

AUGUST 28, 2023

The trial was performed at Altasciences’ clinical facility in Montréal. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. Altasciences helps sponsors get better drugs to the people who need them, faster.

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Agency IQ

JULY 28, 2023

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., While the exact timeline to publication varies after OIRA clearance, AgencyIQ expects publication to occur this quarter, if not sooner.

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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.

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Alta Sciences

JULY 31, 2024

Why Diversity in Clinical Trials Matters A wide variety of factors, from age or biological sex to environmental conditions and lifestyle choices (e.g., substance abuse, sexual activity), can influence the risk and likelihood of developing a disease or other long-term health issues—as well as the way an individual responds to treatment.

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Agency IQ

DECEMBER 11, 2023

Older adults: While certain age-associated factors like comorbidities, age, and weight can be adjusted using standard clinical pharmacology methods; reviewers have noted that these factors do not entirely adjust for the differences we see in older patient populations.

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The Anticancer Fund

JUNE 7, 2022

Ritonavir-Boosted Exposure of Kinase Inhibitors: an Open Label, Cross-over Pharmacokinetic Proof-of-Concept Trial with Erlotinib Published in Pharmaceutical Research This paper reports on an innovative way for using existing non-cancer drugs to reduce the dose and to potentially improve efficacy of approved expensive anticancer drugs.

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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Agency IQ

DECEMBER 1, 2023

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.

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The Pharma Data

FEBRUARY 8, 2021

Hypokalemia, Fluid Retention, and Cardiovascular Adverse Reactions due to Mineralocorticoid Excess – ZYTIGA ® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1)].

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Drug Target Review

JANUARY 20, 2025

This approach underlies the identification of the OBD, backed by both clinical efficacy and drug tolerability data. Pharmacologically-guided dosing : Integrating pharmacokinetics (PK), pharmacodynamics (PD), and translational biomarkers into dose selection tailors drug administration regimens that maximize the therapeutic index of a drug.

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New Drug Approvals

APRIL 18, 2025

Article ] Rosati G: Clinical pharmacology of iomeprol. 2000 May;59(5):1169-86. doi: 10.2165/00003495-200059050-00013. Article ] Katayama H, Spinazzi A, Fouillet X, Kirchin MA, Taroni P, Davies A: Iomeprol: current and future profile of a radiocontrast agent. Invest Radiol. 2001 Feb;36(2):87-96. doi: 10.1097/00004424-200102000-00004.

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New Drug Approvals

APRIL 21, 2025

. “First-in-Human Study of AG10, a Novel, Oral, Specific, Selective, and Potent Transthyretin Stabilizer for the Treatment of Transthyretin Amyloidosis: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Adult Volunteers” Clinical Pharmacology in Drug Development. 9 (1): 115129.

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