Results 21 to 30 of about 781 (182)

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

Journal of Pharmacy & Pharmacognosy Research
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).
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   +7 more
doaj   +2 more sources

BIOWAIVER STUDY OF IMMEDIATE RELEASE GLIMEPIRIDE TABLETS [PDF]

International Journal of Applied Pharmaceutics, 2021
Objective: Demonstrating therapeutic equivalency regarding the efficacy and safety among originator products and generics is a key step in permitting the marketing of generic products. The study aimed to evaluate the bioequivalence of five different generic brands of Glimepiride tablets under biowaiver conditions. Methods: The quality of the ...
SIHAM ABDOUN, DALIA GABER, RAGHAD ALWAHABI, NASHWA ALQUSSIR, NEHAL ALMUTAIRI, WAAD ALSALAMAH   +5 more
core   +3 more sources

Comprehensive UPLC-MS/MS Method for Quantifying Four Key Intestinal Permeability Markers in Caco-2 Models [PDF]

Molecules
A comprehensive UPLC-MS/MS method was developed and validated for the simultaneous separation and quantification of atenolol, propranolol, quinidine, and verapamil, using established intestinal permeability standards in the Caco-2 cell monolayer model ...
Luciana Silva de Araújo, Eduardo José Crevelin, Luiz Alberto Beraldo de Moraes, Niege Araçari Jacometti Cardoso Furtado   +3 more
doaj   +2 more sources

The Evolving Role of In Vitro-In Vivo Correlation in Model-Informed Drug Development: A Multi-Stakeholder Perspective. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT In vitro–in vivo correlation/relationship (IVIVC/R) models such as physiologically based biopharmaceutics modeling (PBBM) are crucial tools that link biopharmaceutical properties to clinical performance. They accelerate development, reduce costly experimental studies and clinical trials, and justify regulatory decisions for drug formulation ...
Chenel M, Fouliard S, Hansson E, Brendel K, Jacobs M, Lennernäs H, Sjögren E, Bergstrand M.   +7 more
europepmc   +2 more sources

EVALUATION OF LINAGLIPTIN DISSOLUTION FROM TABLETS USING HPLC AND UV METHODS

Drug Analytical Research, 2019
Linagliptin (LGT) is used to reduce glucose blood levels in patients with type 2 Diabetes mellitus. The proposed conditions for a biowaiver guide can be applied due to high solubility of linagliptin in aqueous media.
Rita Elena de Abreu Engel, Amanda Thomas Barden, Sarah Chagas Campanharo, Natália Olegário, Nadia Maria Volpato, Elfrides Eva Scherman Schapoval   +5 more
doaj   +9 more sources

Development of a Predictive Flow Through Cell Dissolution Method for Carbamazepine Modified-Release Tablets. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Predictive in vitro dissolution methods are crucial for anticipating in vivo drug performance, particularly for poorly soluble drugs like carbamazepine. In vitro‐in vivo correlations (IVIVC) link dissolution characteristics to pharmacokinetics, facilitating bioequivalence studies and reducing reliance on clinical trials.
Carvajal Barbosa L, Echeverry SM, Aragón DM.   +2 more
europepmc   +2 more sources

A Comparative pH-Dissolution Profile Analysis of Selected Commercial Levothyroxine Formulations in Lebanon Using Anion-Exchange HPLC Method: Implication on Interchangeability. [PDF]

Adv Pharmacol Pharm Sci
Hypothyroidism is a common endocrine disorder that requires medical intervention by the administration of hormone replacement therapy: levothyroxine—a drug recognized as a NTI drug. Generic levothyroxine formulations can be considered as an economic alternative; however, bioequivalence problem has been encountered between various available ...
AlBathish M, Gazy A, Jamal MA.
europepmc   +2 more sources

Open Systems Pharmacology Community Conference (OSP-CC) Proceedings 2025. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Developed at Bayer Technology Services, PK‐Sim and MoBi transitioned into the Open Systems Pharmacology (OSP) Suite, released as free open‐source software in 2017. An active community with stakeholders from academia, industries, and regulators contributes to the continuous improvement of open‐source model‐informed drug development (MIDD). This
Cordes H, Annaert P, Balazki P, Benamara S, Bonan RH, Butler A, Chenel M, Cui Y, Dallmann A, de Witte WEA, Demeester C, Feick D, Gattacceca F, Geci R, Gerebtzoff G, Gruber A, Guimarães M, Hamadeh A, Hanke N, Ibarra M, Ince I, Kanacher T, Kuepfer L, Mil F, Montaseri G, Nauwelaerts N, Proenca S, Schaller S, Schlender JF, Schneider ARP, Sjögren E, Solodenko J, Staab A, Vrenken P, Troisi C, Teutonico D.   +35 more
europepmc   +2 more sources

Biowaiver monograph for immediate-release solid oral dosage forms: Empagliflozin [PDF]

Journal of Pharmaceutical Sciences
Naseem A Charoo, Atsushi Kambayashi, James E Polli   +2 more
exaly   +2 more sources

Biowaiver monograph for immediate-release solid oral dosage forms: Amlodipine besylate. [PDF]

J Pharm Sci
Amlodipine besylate is a calcium channel blocker widely used for treating hypertension and coronary artery disease. This biowaiver monograph evaluates the suitability of BCS-based biowaivers for immediate-release (IR) oral dosage forms containing ...
de la Cruz-Cruz P, García MA, Pérez-Urizar JT, Abrahamsson B, Cristofoletti R, Kambayashi A, Mehta M, Parr A, Polli JE, Shah VP, Charoo N, Talath S, Dressman J, Langguth P.   +13 more
europepmc   +2 more sources