FDA pondering PAT for biologics, but not Phase I drugs; '87 process validation guide may be redefined.(Process analytical technology)

Validation Times | January 1, 2004| | Copyright

WASHINGTON -- FDA officials told a biotech meeting in Washington Jan. 8 that they are considering broadening the scope of its Process Analytical Technology (PAT) Initiative to include biologics, since facets of PAT are more widely used in the biotech industry than with molecular entities, but are not considering PAT for Phase I studies, despite some interest raised at a meeting here.

Ajaz Hussain, Ph.D., deputy director for pharmaceutical science, Center for Drugs, told the California Separation Science Society's Well-Characterized Biological Production (WCBP) ...

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