title: Plasma pooling: utility in expediting bioequivalence assessment of rifampicin-containing fixed-dose combinations.
abstract: 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.
authors.affiliation: Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, SAS Nagar, India.
authors.forename: Y
authors.initials: Y
authors.lastname: Ashokraj
authors.forename: I
authors.initials: I
authors.lastname: Singh
authors.forename: K J
authors.initials: KJ
authors.lastname: Kaur
authors.forename: G
authors.initials: G
authors.lastname: Kohli
authors.forename: S R
authors.initials: SR
authors.lastname: Bhade
authors.forename: M V S
authors.initials: MV
authors.lastname: Varma
authors.forename: C L
authors.initials: CL
authors.lastname: Kaul
authors.forename: R
authors.initials: R
authors.lastname: Panchagnula
mesh_terms: 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
chemical_list: D000904:Antibiotics, Antitubercular; D004338:Drug Combinations; D012293:Rifampin