Microdose Study Establishes Mass Balance of Elacytarabine
Quotient Clinical announced the completion of a microdose study to establish the mass balance of elacytarabine in healthy subjects.
Quotient Clinical, a business unit of Quotient Bioresearch, announced the completion of a 14C microdose study with Clavis Pharma, to establish the mass balance of elacytarabine in healthy subjects. The clinical study was an open label, single-dose study to assess the mass balance recovery of an intravenous microdose of 14C-elacytarabine and involved the first dosing of elacytarabine, a cytotoxic molecule, to healthy male subjects.
The study requirement was driven by a request from the US Food and Drug Administration (FDA) to provide information on the routes of elimination of total radioactivity and total recovery. By performing the study in healthy subjects, Clavis Pharma was able to avoid the complications of extended recruitment periods and potential inconsistency in compliance of a study in patients, according to a company press release.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
