Cell Based Assays, Drugs and Pharmacokinetics

Cell Based Assays

Drugs

Pharmacokinetics

Inside The Altascientist Issue 41: Immunomodulation Assessments for Clinical Trials–Sophisticated Bioanalytical Approaches to Support Complex Modalities

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. Each class of immunomodulator has a defined complexity and mechanism of action.

Clinical Trials

Clinical Trials Trials Pharmacokinetics Small Molecule

ChEMBL 34 is out!

The ChEMBL-og

APRIL 16, 2024

We are delighted to announce the release of ChEMBL 34, which includes a full update to drug and clinical candidate drug data. 71 out of the 882 newly added EMA drugs are only authorised by EMA, rather than from other regulatory bodies e.g. FDA. This data is currently available for European Medicines Agency drugs only.

Clinical Trials

Clinical Trials FDA Cell Based Assays Compound Screening

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Drug Discovery Today

Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

Animal Testing

Animal Testing Biosimilars Cell Based Assays FDA

The Novel GlycoPEGylated FGF21 Analog Pegozafermin Activates Human FGF Receptors and Improves Metabolic and Liver Outcomes in Diabetic Monkeys and Healthy Human Volunteers [Drug Discovery and Translational Medicine]

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

Cell Based Assays Pharmacokinetics Regulations Treatment

Leadeth me unto Truth and delivereth me from those who have already found it

Molecular Design

MARCH 26, 2024

These points do need be stressed given the expanding range of modalities being exploited by drug designers and the increasing use of AI/ML in drug design. Overcoming these challenges will amplify the impact of structural biology on drug discovery.