In this field, the use of microarrays has been expanding exponentially to several areas such as genetic screening, safety assessment and diagnostics [ 14], but repeatability of published microarray studies is apparently limited [ 15, 16].
Quality control standards for the clinical use of iPSC are still to be defined, and they will have to assess aspects such as genetic stability, safety, purity and identity.
The use of shDNAs as artificial mTRs opens the door to engineering a new generation of AAV vectors with improved potency, genetic stability, and safety for both preclinical studies and human gene therapy.
In contrast to the EMEA indications, routine genetic toxicology and safety pharmacology tests are not required.
However, genetic manipulations raise safety concerns and are thus not desirable in most clinical applications.
Along with the development of plant genetic engineering, transgenic safety was also seriously considered.
Consequently, considerable information is already available on their biological and genetic characteristics, immunogenicity, safety, efficacy, and duration of immunity (24, 25, 35 – 35 ).
Suspension culturing of cells facilitates large scale expansion, but we note that it will still be necessary to validate the genetic stability and safety of cells after long term cell growth before they can be used therapeutically.
Statistical analysis will be performed to determine the association between occupational exposure to antineoplastic drugs (evaluated by environmental and biological monitoring) and biomarkers of DNA and chromosome damage, taking into consideration the effect of genetic polymorphisms, the safety procedures adopted, and confounding exposures of non-occupational origin.
