Biomedical Engineering Reference
In-Depth Information
acceptance criteria, identify how the assay will be reported, determine what reg-
ulatory guidelines are applicable, and describe controls required to monitor and
standardize results between experiments. Written standard operating procedures are
recommended to ensure methods are performed as expected. This validation plan will
become the guideline for successful validation of a high-quality assay.
12.4 SUMMARY
With the rapid development of instrumentation, reagents, and analysis software, flow
cytometry has been widely used in different stages of drug discovery and develop-
ment programs, including target identification, compound screening, biomarker
development for proof of principle/mechanism of action, preclinical and clinical
toxicology, immunogenicity, and clinical diagnosis. It is challenging, however, to
implement the flowcytometry assays to various stages of drug programs. On the basis
of the intended use of data, the stringency of assay validation varies and the lab shall
be compliant with different regulatory guidelines (Table 12.2). In addition, due to
lack of specific regulatory guidelines for biomarker development, it is commonly
accepted to implement fit-for-purpose approaches for biomarker assay development
and validation. Therefore, it is critical to develop an implementation plan for assay
qualification, validation, and clinical sample analysis. Prior to the initiation of assay
TABLE 12.2 Regulatory Agencies
Regulatory
Jurisdiction
Guidelines Agency
Objectives
Reference
GLP
FDA
Preclinical animals,
toxicology, and
in vitro testing
(United States)
Consistency
and reliability
of results
21CFR58
www.fda.gov
OECD
Nonclinical
research studies
(International)
Directive 67/548/EEC
www.oecd.org/
department
GCP
FDA
Clinical trials
on humans
Safety and
protection of
trial subjects
while obtaining
credible data
21CFR312
www.fda.gov
ICH
CPMP/ICH/135/95
www.ich.org
CLIA
Center for
Medicare
and
Medicaid
Services
All human
laboratory
testing
except research
(United States)
Patient safety
management
and disease
monitoring
42CFR493
www.cms.hhs.gov/
clia
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