The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Harrison, MD, Director, Summit Clinical Research. NASH Investor Event Information. About PXL770.

Trials 40

Trials Disease Treatment Pharmacokinetics 40

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Combination products are defined by the FDA as : “A product comprised of two or more regulated components (i.e.,

Science 40

Science FDA Production Trials 40

Alta Sciences

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

Therapies 52

Therapies Pharmacokinetics Pharmacogenetics Clinical Trials 52

PPD

APRIL 14, 2025

To that end, the PI can ensure patients understand the science of appetite and metabolic regulation, for example, to relieve some of the self-imposed expectations for instant weight loss or other quick signs of success. Whatever the reason behind a patients fatigue, education and encouragement are key to continued engagement.

Clinical Trials 52

Clinical Trials Trials Clinical Development Disease 52

Alta Sciences

JULY 31, 2024

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. Discover how drug developers, researchers, and regulators are ensuring this happens.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Drug Development 52

PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. Does your CRO look after your most valuable resources?

Clinical Trials 52

Clinical Trials Drug Development Trials Clinical Research 52

FDA Law Blog: Drug Discovery

JULY 9, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition.

FDA 59

FDA Clinical Trials Disease Trials 59

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.

Drugs 40

Drugs Clinical Trials Trials Treatment 40

Agency IQ

FEBRUARY 2, 2024

The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more. This collaboration examining trial formats involved “numerous discussions with regulators, including the US FDA and the EMA Innovation Task Force,” as well as workshops.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. at a Friends of Cancer Research event in February 2024. ANNA ESHOO (D-Calif.)

FDA 40

FDA Science Clinical Trials Production 40

The Pharma Data

DECEMBER 23, 2020

With the integration of both parties’ technologies, BioMedion will provide a new operating system for regulated applications operating effectively on one platform in controlled environments. Following the acquisition, the arivis5D content platform will be rebranded to neuronOS.

Licensing 52

Licensing Licensing Vaccine Trials 52