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.

Pharmacokinetics 100

Pharmacokinetics Metabolic Stability Clinical Pharmacology Disease 100

Drug Target Review

APRIL 7, 2025

However, standard preclinical safety assessment studies may not accurately predict adverse events in humans, particularly with emerging modalities like precision medicine targeting human antigens or genes not present in preclinical species. For use as endpoints, biomarkers must be correlated to a valid clinical outcome. Rodrigues AD.

Clinical Development 59

Clinical Development Clinical Trials Clinical Pharmacology Trials 59

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. food effect, smoking, and drug-drug interactions) on drug exposure and response.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

The Pharma Data

FEBRUARY 8, 2021

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Watch it now. The Altascientist : Issue No.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

Agency IQ

SEPTEMBER 15, 2023

According to the FDA’s agenda, linked above, and the meeting minutes , Leslie Hendeles, Randy Hatton, and Jonathan Shuster of the University of Florida gave presentations supporting the assertions they had made in their petition. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

JULY 28, 2023

According to the notice, the contract includes at least three deliverables: (1) an internal report or presentation to FDA, (2) a public workshop with stakeholders using data collected and published in the Federal Register Notice, and (3) a summary of the public workshop and recommendations to inform potential updates to FDA’s guidances.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40