Development and validation of a UV spectrophotometric method for biowaiver studies in pyrazinamide tablets

Development and validation of a UV spectrophotometric method for biowaiver studies in pyrazinamide tablets

Context: For regulatory reasons, a biowaiver is characterized as the substitution or exemption of bioavailability and/or bioequivalence research with in vitro dissolution tests, according to the Biopharmaceutical Classification System (BCS). These studies need validated quantification methods to giv...

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Bibliographic Details
Main Authors: Vanessa Saldaña-Bobadilla, Cintia P. Barreto-Villanueva, Frizzi J. Ganoza-Gasco, Enma Perez-Chauca, Olga E. Caballero-Aquiño, Ana E. Mantilla-Rodriguez, Pedro M. Alva-Plasencia, Maria S. Aurora-Prado
Format: Article
Language:English
Published: GarVal Editorial Ltda. 2024-05-01
Series:Journal of Pharmacy & Pharmacognosy Research
Subjects:
antitubercular drugs
bioequivalence
drug dissolution
solubility
spectrophotometry
Online Access:https://jppres.com/jppres/pdf/vol12/jppres23.1846_12.3.539.pdf

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https://jppres.com/jppres/pdf/vol12/jppres23.1846_12.3.539.pdf

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