The use of stratefied sampling of blend and dosage units to demonstrate adequacy of mix for powder blends

Garth Boehm, Jon Clark, John Dietrick, Laura Foust, Thomas Garcia, Muralidhara Gavini, Loren Gelber, Jean Marie Geoffroy, Jack Hoblitzell, Pedro Jimenez, Gerald Mergen, Fernando Muzzio, Jerry Planchard, James Prescott, Jozef Timmermans, Neeru Takiar

Research output: Contribution to journalReview article

26 Scopus citations

Abstract

In response to concerns expressed by applicants regarding inconsistent policies in establishing blend uniformity acceptance criteria to demonstrate adequacy of mix, the FDA Office of Generic Drugs (OGD) issued the draft document Guidance for Industry, ANDAs: Blend Uniformity Analysis (August 1999)2. Both generic and innovator pharmaceutical companies raised a number of concerns following the publication of this document. As a result, the Product Quality Research Institute (PQRI) Blend Uniformity Working Group (BUWG) was established in February 2000. One of the primary goals of this group was to draft a scientifically based alternative to the OGD document. The resulting recommendation addresses both FDA and industry concerns by substantially enhancing product quality assurance without increasing regulatory burden. The PQRI BUWG recommends that these blend and dosage unit uniformity requirements be administered uniformly throughout the industry. PQRI submitted the following recommendation to the FDA on December 31, 2002, providing the Agency with an alternative strategy to consider when drafting future regulatory policy to assess blend and dosage unit uniformity.

Original languageEnglish (US)
Pages (from-to)64-74
Number of pages11
JournalPDA Journal of Pharmaceutical Science and Technology
Volume57
Issue number2
StatePublished - Mar 1 2003

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science

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    Boehm, G., Clark, J., Dietrick, J., Foust, L., Garcia, T., Gavini, M., Gelber, L., Geoffroy, J. M., Hoblitzell, J., Jimenez, P., Mergen, G., Muzzio, F., Planchard, J., Prescott, J., Timmermans, J., & Takiar, N. (2003). The use of stratefied sampling of blend and dosage units to demonstrate adequacy of mix for powder blends. PDA Journal of Pharmaceutical Science and Technology, 57(2), 64-74.