Viral testing is needed for medicinal products that are manufactured using raw materials of biological origin in order to
ensure safety. The International Conference on Harmonization (ICH) Q5A Guideline, Viral Safety Evaluation of
Biotechnology Products Derived from Cell Lines of Human Origin or Animal Origin, has included conventional
in vitro
and
in vivo viral tests since 1999. ICH Q5A is currently undergoing revision to take account of new technologies for
detecting viruses. Under these circumstances, re-evaluation of the
in vitro and
in vivo tests is crucial for developing a flexible and effective framework of virus testing. This study focuses on comparative studies of the
in vitro and
in vivo tests.
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