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.

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Pharmacokinetics Metabolic Stability Clinical Pharmacology Disease 100

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.

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Pharmaceutical Companies Treatment Clinical Trials Therapies 52

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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FDA Pharmacokinetics Clinical Pharmacology Government 40

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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Clinical Trials Drugs Trials Treatment 40

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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Science FDA Trials Clinical Pharmacology 40

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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