Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure - Pharmaceutical Technology

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Regulatory Update: The IPEC Novel Excipient Safety Evaluation Procedure
The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.


Pharmaceutical Technology
Volume 33, Issue 11, pp. 72-82

Conclusion

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 manner.

Christopher DeMerlis, M.S.,* is a manager of regulatory affairs at Colorcon, Inc., 415 Moyer Blvd., West Point, PA 19486,
. 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,

*To whom all correspondence should be addressed.

References

1. B. Hughes, Nat. Rev. Drug Discov. 8, 93–96 (2009).

2. P. Van Arnum, Pharm. Technol. 33 (4), 44–51 (2009).

3. M.J. Hall et al., Supplement to Pharm. Technol., s26–s29 (April 2009).

4. FDA, Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (Rockville, MD, 2005).

5. M. Steinberg et al., Reg. Toxicol. Pharmacol. 24, 149–154 (1996).

6. FDA, Draft Guidance for Industry: Nonclinical Studies for the Development of Pharmaceutical Excipients (Rockville, MD, 2002).

7. ICH, M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, 1997.

8. P. M. Wax,. Ann. Intern. Med. 122, 456–461 (1995).

9. P. Baldrick, Reg. Toxicol. Pharmacol. 32, 210–218 (2000).

10. G. Pifferi and P. Restani, Il Farmaco 58, 541–550 (2003).

11. G. Pifferi, P. Santoro, and M. Pedrani, Il Farmaco 54, 1–14 (1999).

12. E. Knight, Int. J. Toxicol. 22, p. 371 (2003).

13. M. Steinberg and I. Silverstein, Int. J. Toxicol. 22, 373–375 (2003).

14. R.E. Osterberg and N.A. See, Int. J. Toxicol. 22, 377–380 (2003).


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