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

Drug Discovery World

AUGUST 10, 2022

Given the risks, it is important to detecta nd screen out RCVs in CAR T cell therapy batches. Cell-based assays often require considerable time to produce results. qPCR delivers results quickly, but manufacturers cannot necessarily use it to guarantee a CAR T cell batch’s safety due to its limited sensitivity.

Therapies 246

Therapies Virus Treatment Engineering 246

Molecular Design

MARCH 26, 2024

With apologies to Manfred Eigen (1927 - 2019) I've just returned to Cheshire from the Caribbean and, to kick off blogging from 2024 I'll share a photo of the orchids at Berwick-on-Sea on the north coast of Trinidad. A theory has only the alternative of being true or false. A model has a third possibility: it may be true, but irrelevant.

Pharmacokinetics 83

Pharmacokinetics Drugs Cell Based Assays Engineering 83