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.

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Agency IQ

FEBRUARY 23, 2024

In between, panelists and presenters also discussed alternative designs for dose-finding trials and creative strategies for evaluating and modeling early clinical data. 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.

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Agency IQ

DECEMBER 11, 2023

OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings. months, according to the GSK presentation. To start, age was repeatedly mentioned by OCE presenters at meetings in 2023 and was featured in several guidance documents published by OCE as well.

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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.

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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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The Anticancer Fund

JUNE 7, 2022

Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ). This pharmacokinetic study (n=9) compared half-dose erlotinib (75 mg/day) with the HIV drug ritonavir (200 mg/day) with full-dose erlotinib (150 mg/day).

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Agency IQ

FEBRUARY 15, 2024

FDORA Legislation Antimicrobial FDA will publish a draft guidance describing considerations for developing presentations, container closure systems and device constituent parts for proposed interchangeable biosimilar biological products.

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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.

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New Drug Approvals

APRIL 18, 2025

PATENT [link] The process for preparing iopromide of formula (1) according to the present invention is shown in the following reaction scheme 5. The present invention will be explained more specifically by the following examples. However, the examples are not intended to limit the scope of the present invention thereto.

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