PMID- 14674508
OWN - NLM
STAT- MEDLINE
DCOM- 20040223
LR  - 20161021
IS  - 1079-7440 (Print)
IS  - 1079-7440 (Linking)
VI  - 57
IP  - 2
DP  - 2003 Mar-Apr
TI  - The use of stratefied sampling of blend and dosage units to demonstrate adequacy 
      of mix for powder blends.
PG  - 64-74
AB  - 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). 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.
FAU - Boehm, Garth
AU  - Boehm G
AD  - Faulding, Inc.
FAU - Clark, Jon
AU  - Clark J
FAU - Dietrick, John
AU  - Dietrick J
FAU - Foust, Laura
AU  - Foust L
FAU - Garcia, Thomas
AU  - Garcia T
FAU - Gavini, Muralidhara
AU  - Gavini M
FAU - Gelber, Loren
AU  - Gelber L
FAU - Geoffroy, Jean-Marie
AU  - Geoffroy JM
FAU - Hoblitzell, Jack
AU  - Hoblitzell J
FAU - Jimenez, Pedro
AU  - Jimenez P
FAU - Mergen, Gerald
AU  - Mergen G
FAU - Muzzio, Fernando
AU  - Muzzio F
FAU - Planchard, Jerry
AU  - Planchard J
FAU - Prescott, James
AU  - Prescott J
FAU - Timmermans, Jozef
AU  - Timmermans J
FAU - Takiar, Neeru
AU  - Takiar N
LA  - eng
PT  - Journal Article
PL  - United States
TA  - PDA J Pharm Sci Technol
JT  - PDA journal of pharmaceutical science and technology
JID - 9439538
RN  - 0 (Powders)
SB  - IM
MH  - Chemistry, Pharmaceutical
MH  - Drug Industry/legislation & jurisprudence/standards
MH  - Guidelines as Topic
MH  - Powders/chemistry/*standards
MH  - Quality Control
MH  - Sample Size
MH  - Technology, Pharmaceutical/legislation & jurisprudence/*standards
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2003/12/17 05:00
MHDA- 2004/02/24 05:00
CRDT- 2003/12/17 05:00
PHST- 2003/12/17 05:00 [pubmed]
PHST- 2004/02/24 05:00 [medline]
PHST- 2003/12/17 05:00 [entrez]
PST - ppublish
SO  - PDA J Pharm Sci Technol. 2003 Mar-Apr;57(2):64-74.