REFERENCE-SCALED AVERAGE BIOEQUIVALENCE STUDY OF PAROXETINE UNDER FED CONDITIONS: VALIDATION OF SAMPLE SIZE ESTIMATION BY BOOTSTRAPPING TECHNIQUE
Journal Title: Asian Journal of Pharamceutical and Clinical Research - Year 2019, Vol 12, Issue 5
Abstract
Objective: New technique was adopted and validated to estimate pivotal sample size from the pilot study data and to establish bioequivalence (BE) of highly variable drugs (HVD), paroxetine, a novel controlled release (CR) matrix tablets utilized ghatti Gum as a rate controlling membrane, in human subject under fed conditions by reference scale design. Methods: Bootstrapping technique was adopted to calculate the pivotal sample size from pilot study data for HVD paroxetine. The reliability and validation of the method were tested in a semi replicate three sequence (RRT, RTR, and TRR where T stand for test drug and R stand for reference drug) cross-over BE study in 24 healthy subjects under fed conditions. Results: The ratio of the pharmacokinetic (PK) metric obtained from the bootstrapping technique after log transformation was 1.04 for Cmax, 1.23 for AUCT, and 1.21 for AUCI with corresponding power of the study which was greater than 80% from pilot study data simulation. The ratio of the PK metric obtained from the reference scaling design in the present study was 1.00 for Cmax, 1.21 for AUCT, and 1.17 for AUCI. The upper limit of the Cmax, AUCT, and AUCI at 95% confidence limit was −0.143, −0.136, and −0.17, respectively. Conclusion: The test paroxetine CR formulation was bioequivalent with reference drug under fed conditions. The technique used for estimation of the sample size in the pivotal study was found reliable, and bootstrapping technique plays an important role in calculating sample size where intrasubject variability was immaterial.
Authors and Affiliations
CHANDRAKALA V , UTPAL KUMAR SANKI
Keywords
Related Articles
- EP ID EP604719
- DOI -
- Views 124
- Downloads 0
BIOCHEMICAL ALTERATIONS IN POSTMENOPAUSAL WOMEN HAVING OSTEOPORIC RISK
AbstractObjective: Osteoporosis is the most common disease worldwide, nutritional factors may play a significant role in the progression of the disease. The aim of this study was to assessment of various biochemical para...
PHYTOCHEMICAL MANAGEMENT OF DIABETIC COMPLICATIONS, EXPERIMENTAL EVIDENCES
It is progressively obvious that not only is a cure for the current worldwide diabetes epidemic required but also for its major complications, affecting both small and large blood vessels. These complications occur in th...
ARTEMISININ CONTENT ON ARTEMISIA ANNUA L. TREATED BY GLORIOSA SUPERBA SEEDS’ WATER EXTRACT
Objective: The aim of this study was to determine the artemisinin content on Artemisia annua L. treated by water extract of Gloriosa superba seeds.Methods: G. superba seeds obtained naturally on Krakal Beach, Gunung Kidu...
CYTOTOXIC ACTIVITY OF ANREDERA CORDIFOLIA LEAF EXTRACT ON HELA CERVICAL CANCER CELLS THROUGH p53-INDEPENDENT PATHWAY
 Objective: This study investigated cytotoxic activity and apoptosis induction of Anredera cordifolia leaf extract on cervical cancer cells.Methods: A. cordifolia leaf extract was prepared by maceration using 70% ethano...
A A VALIDATED REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-CHARGED AEROSOL DETECTOR TECHNIQUE FOR THE SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND ERTUGLIFLOZIN IN PURE AND PHARMACEUTICAL DOSAGE FORMS
Objective: The main objective of the present work is to develop and validate a selective reverse-phase (RP) high-performance liquid (HPLC)-charged aerosol detection technique for the quantitation of the sitagliptin and e...