The program outlined herein considers typical excipients. With the advent of biotechnology derived pharmaceuticals, new excipients
for biotechnology drugs becomes a program development issue. How these new excipients would be examined in toxicology programs
is yet to be determined. Moreover, with increasing emphasis on nanotechnology, these materials potentially represent new processes
for drug delivery. Safety assessment of nanotechnology products is in its infancy, and how these materials will be evaluated
remains to be determined as well. Finally, the outline of this tiered approach has not been a consideration by FDA, although
a tiered-testing rationale is part of several regulatory guidance documents (e.g., metabolite testing, ICH Q3b impurity qualification).
Hence, how the regulatory agency and, more importantly, API sponsors, will accept such an approach remains to be seen. Regardless,
excipient sponsors should consider such an approach because it will limit cost and could advance a new excipient in a timelier
Christopher DeMerlis, M.S.,* is a manager of regulatory affairs at Colorcon, Inc., 415 Moyer Blvd., West Point, PA 19486, CDeMerlis@colorcon.com
. Jay Goldring, PhD, is prior director of toxicology at Wyeth Consumer Healthcare, Ranga Velagaleti, PhD, is a manager of regulatory affairs at BASF Corporation, William Brock, PhD, is principal of Brock Scientific Consulting, and Robert Osterberg, PhD, is a senior consultant of pharmacology/toxicology at Aclairo PDG. For specific information about IPEC's procedure, contact
Dr. Osterberg, tel. 703.506.6760, ext. 302, ROsterberg@aclairo.com
*To whom all correspondence should be addressed.
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