ASPET

AUGUST 10, 2023

In cell-based assays, pegozafermin had a similar receptor engagement profile as native FGF21, with approximately 8-fold higher potency at FGF receptor 1 (FGFR1). Pharmacokinetic half-lives ranged from 55 to 100 hours over the clinically relevant dose range, consistent with the expected half-life extension by glycoPEGylation.

Cell Based Assays 100

Cell Based Assays Pharmacokinetics Regulations Treatment 100

Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials.

Clinical Trials 52

Clinical Trials Trials Pharmacokinetics Small Molecule 52

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

The definition goes on to list potential options for such tests: cell-based assays, organ chips and microphysiological systems, computer modeling, other nonhuman or human biology-based test methods such as bioprinting, as well as animal tests. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

Molecular Design

MARCH 26, 2024

For example, we might examine the structure-activity relationship in a cell-based assay for consistency with the structure-activity relationship that we’ve observed in the enzyme inhibition assay. We have to make assumptions in these situations and we also need to check that these assumptions are reasonable.

Drugs 60

Drugs Pharmacokinetics Cell Based Assays Treatment 60

The ChEMBL-og

APRIL 16, 2024

For legacy AUC and Cmax records (< ChEMBL 34), pharmacokinetic parameters have been extracted from the assay descriptions using regular expression matching (RegEx). University of Dundee: T. 1813 bioactivities in total have been added. When possible, AUC record units were converted to ng.hr.mL-1

Clinical Trials 108

Clinical Trials FDA Cell Based Assays Compound Screening 108