PMID- 11068696
OWN - NLM
STAT- MEDLINE
DCOM- 20010215
LR  - 20190921
IS  - 0363-9045 (Print)
IS  - 0363-9045 (Linking)
VI  - 26
IP  - 11
DP  - 2000 Nov
TI  - RSD requirement for different sample size for blend sampling.
PG  - 1213-6
AB  - A formula for calculating the equivalent relative standard deviation (RSD) for 
      different sample sizes other than the Office of Generic Drugs (OGD) draft 
      guidance was derived. These critical values vary with the population RSD and the 
      sample size and guarantee the same confidence of passing a batch similar to the 
      OGD blend uniformity test. Simulation results showed that the normal 
      approximations give very close results to the simulation results. An assessment 
      of the proposed OGD blend uniformity criteria against the first-stage USP content 
      uniformity (CU) criteria for tablets was also made.
FAU - Saranadasa, H
AU  - Saranadasa H
AD  - Ortho-McNeil Pharmaceutical, Raritan, NJ 08869, USA.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - 0 (Drugs, Generic)
SB  - IM
MH  - Drugs, Generic/*standards
MH  - *Probability
MH  - Sample Size
MH  - *Therapeutic Equivalency
EDAT- 2000/11/09 11:00
MHDA- 2001/03/03 10:01
CRDT- 2000/11/09 11:00
PHST- 2000/11/09 11:00 [pubmed]
PHST- 2001/03/03 10:01 [medline]
PHST- 2000/11/09 11:00 [entrez]
AID - 10.1081/ddc-100100994 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2000 Nov;26(11):1213-6. doi: 10.1081/ddc-100100994.