Drug Target Review

APRIL 7, 2025

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Trial design and statistical methods are also key to determining the utility and validity of biomarkers.

Clinical Development 59

Clinical Development Clinical Trials Clinical Pharmacology Trials 59

Agency IQ

AUGUST 11, 2023

These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more. A core focus of BIMO is on clinical data integrity and uncovering mistakes or outright clinical trial fraud.

FDA 40

FDA Compliance Clinical Trials Pharmacokinetics 40

Vial

MARCH 15, 2024

Nonetheless, while CROs play a pivotal role in streamlining operations and providing specialized expertise, sponsors continue to bear critical responsibilities throughout the clinical trial journey.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 52

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. Analysis, and what’s next In general, this guideline is attempting to cover a large amount of regulatory territory in a single document.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

FDA 40

FDA Research Clinical Trials Trials 40

Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. Read AgencyIQ analysis here for a detailed discussion of these issues. ]. See AgencyIQ’s analysis of the draft guidance here. ].

FDA 40

FDA Trials Therapies Regulations 40

Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52