|
Accium BioSciences offers
study design, bioanalytical and reporting services using its in-house
Accelerator Mass
Spectrometer (AMS). The AMS platform permits the most sensitive detection
and quantification of novel drugs and metabolites in biological samples. Accium
BioSciences offers services in three critical areas of early drug
development:
Phase 1 -
Pharmacokinetics, Absolute Bioavailability, Mass Balance and Metabolite Profiling
- Accium BioSciences offers an option for
14C-labeled Phase 1 PK and ADME studies which lowers radiation
exposure risk to study subjects
- AMS is ideal for human mass balance studies
- AMS enables extremely sensitive detection and
quantification of samples for today’s highly potent compounds
- Accium BioSciences has also developed
techniques that help detect and identify rare and potentially
problematic drug metabolites earlier in clinical trails
Microdosing -
Phase 0
Exploratory-IND Studies
- Obtain early human bioavailability and PK data
- Accium BioSciences specializes in the design
and implementation of microdosing studies following the recent release
of FDA Exploratory IND draft guidance
- We offer the first U.S. based microdosing
bioanalytical service
- This turn-key offering covers study design,
clinical trials, and bioanalytical services managed through a chain of
in-house AMS service and a network of highly qualified clinical and
regulatory partners
Preclinical - PK and ADME Studies
- Preclinical PK/ADME studies are conducted with
low specific-activity 14C labeled compounds
- Samples generated from experiments using
highly potent compounds (nanomolar doses) and compounds with low
bioavailability are easily quantified with the AMS platform
- AMS allows precise detection and
quantification of drug concentration in any tissue type or excreta
|
