bioanalytical lab

bioanalytical lab

A place, establishment or institution organised and operated primarily for performing chemical, microscopic, serologic, parasitologic, bacteriologic or other tests, by the practical application of one or more of the fundamental sciences to material originating from the human body, for the purpose of obtaining scientific data which may be used as an aid to ascertain the state of health. This does not include interpretation of cytological and histological criteria of disease.
References in periodicals archive ?
In addition to the GMP labs in Athlone and Middleton, PPD Laboratories' operations also include a bioanalytical lab in Middleton; vaccine sciences, bioanalytical and biomarker labs in Richmond, VA; central labs in Shanghai, China; Brussels, Belgium; Highland Heights, Kentucky; and Singapore; and a biomarker lab in Highland Heights.
As a GLP bioanalytical lab, ABS Laboratories specializes in complex assay method development and validation for the quantification of drugs, metabolites and biomarkers in biological samples for preclinical and clinical trials including final regulatory submission.
The vaccine sciences lab is part of PPD's Richmond bioanalytical lab, which provides services such as small molecule, biologics and biomarker testing capabilities for all phases of drug development.
Staff of the bioanalytical lab in Poitiers, France will join Synchron's bioanalytical business unit.
As a GLP bioanalytical lab, ABS specializes in complex assay method development and validation for the quantification of drugs, metabolites and biomarkers in biological samples for preclinical and clinical trials including final regulatory submission.
Worldwide specialists in central nervous system, cardiovascular, metabolic, immune-mediated inflammatory disorders, oncology and rare disease research, offers bioanalytical Lab and phase I-IIA, phase IIB-IIIB and phase IV clinical trial services.
Pharmaceutical Product Development, a global contract research organisation providing discovery, development and post-approval services, as well as compound partnering programs, has named Bruce Stouffer as the executive director of immunochemistry in the PPD Laboratories' bioanalytical lab, it is reported today.
Jerome Ferrance, research assistant professor at University of Virginia's (Charlottesville, VA) department of chemistry's bioanalytical lab, says he has only one or two suppliers capable of offering the full range of chemicals his lab needs.
FS: For phase I first-in-human studies, sponsors usually need quality controlled data in approximately 5 business days from sample receipt at the bioanalytical lab. To meet these needs, it is critical for us to collaborate with the toxicology and clinical facilities regarding dosing dates, planned shipment dates, data format requirements, logistics of labels and plasma transfer tubes, and beyond.
Clinigene has a CAP-accredited central laboratory and GLP-compliant Bioanalytical lab for small and large molecule therapeutics.
BLS assets will be combined with BioPharma's existing Bioanalytical Lab to further expand and fortify its analytical services and become a leader in clinical research.
What does this language in these documents mean for the bioanalytical lab? In reality, not much: There is still little room for interpretation regarding the need to develop and validate an ATA assay for Investigational New Drug (IND) enabling studies.