Plasma pooling: utility in expediting bioequivalence assessment of rifampicin-containing fixed-dose combinations.
To improve the rapidity of the registration process of rifampicin (RMP) containing fixed-dose combination (FDC) formulations, a plasma pooling methodology was used to increase the throughput of bioanalysis of plasma samples from bioequivalence trials of FDCs. Plasma samples of a biostudy were analysed for RMP using traditional analysis methods as well as a plasma pooling method (volunteer and time pooling). Both methods produced similar results, with less than 15% variability in both volunteer and time pooling. The plasma pooling method for bioanalysis was validated. Further studies are required to identify and reduce the percentage variability.
Ashokraj
Y
Y
Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, SAS Nagar, India.
Singh
I
I
Kaur
K J
KJ
Kohli
G
G
Bhade
S R
SR
Varma
M V S
MV
Kaul
C L
CL
Panchagnula
R
R
D000904:Antibiotics, Antitubercular / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D004338:Drug Combinations; D006801:Humans; D012293:Rifampin / Q000097:blood / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D000904:Antibiotics, Antitubercular; D004338:Drug Combinations; D012293:Rifampin