title: In vitro to in vivo profiling: an easy idea for biowaiver study.
abstract: The aim of this article was to assess and apply the in vitro to in vivo profiling (IVIVP), a new biowaiver approach, in designing a product with specific release pattern. The IVIVP was established by plotting the observed and predicted plasma drug concentrations. For IVIVP, convolution approach was employed to estimate plasma drug concentrations from in vitro dissolution profiles. The IVIVP for T1S exhibited a good correlation coefficient (R2 = 0.963) followed by the T2 (R2 = 0.682), T3 (R2 = 0.665), T1 (R2 = 0.616), and Mepresso (R2 = 0.345). Establishing an IVIVP, based on the convolution approach, can be more useful and practicable in the biowaiver studies, rather than present not useful practice of IVIVC estimated via deconvolution approach. This paper also elaborates that there is good correlation between the in vitro and in vivo profiles of the developed metoprolol tartrate formulations, particularly for T1S.
authors.affiliation: Department of Mathematics, The Islamia University of Bahawalpur, Bahawalpur 63100, Pakistan.
authors.forename: Abdulhakim A A
authors.initials: AA
authors.lastname: Khaled
authors.forename: Khalid
authors.initials: K
authors.lastname: Pervaiz
authors.forename: Sonia
authors.initials: S
authors.lastname: Khiljee
authors.forename: Sabiha
authors.initials: S
authors.lastname: Karim
authors.forename: Qurat-ul-Ain
authors.initials: QU
authors.lastname: Shoaib
authors.forename: Ghulam
authors.initials: G
authors.lastname: Murtaza
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000737:chemistry / Q000493:pharmacokinetics; D000465:Algorithms; D003198:Computer Simulation; D004339:Drug Compounding; D005079:Excipients; D005544:Forecasting; D008790:Metoprolol / Q000737:chemistry / Q000493:pharmacokinetics; D053758:Nanoparticles; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D010599:Pharmacokinetics; D011109:Polymethacrylic Acids; D012995:Solubility; D013607:Tablets
chemical_list: D000319:Adrenergic beta-Antagonists; D005079:Excipients; D004364:Pharmaceutical Preparations; D011109:Polymethacrylic Acids; D013607:Tablets; C038300:methylmethacrylate-methacrylic acid copolymer; D008790:Metoprolol