Results 11 to 20 of about 1,008 (71)

Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development [PDF]

The AAPS Journal, 2022
AbstractDissolution specifications are often essential in assuring the quality and consistency of therapeutic benefits of drug lots released to the market as in vitro dissolution is often considered to be a surrogate for bioavailability. Despite the importance of demonstrating the clinical relevance of the dissolution specifications, it is often ...
Mohamed-Eslam F. Mohamed, Insa Winzenborg, Ahmed A. Othman, Patrick Marroum   +3 more
openaire   +2 more sources

Post-market surveillance of albendazole tablet brands in Kenya: Implications for deworming programs and clinical outcomes. [PDF]

PLoS Negl Trop Dis
Yator EK, Njogu PM.
europepmc   +1 more source

Application of New Approach Methodologies to Improve Oral Biopharmaceutic Assessments. [PDF]

Pharmaceutics
García MA, Cabrera-Pérez MÁ, González PM, Aceituno A, Hachim D.   +4 more
europepmc   +1 more source

Pharmaceutical quality and cost-effectiveness of branded versus generic medicines across 22 drug types and 8 therapeutic categories: a citizen-funded comparative study from regulated retail outlets in Kerala, India. [PDF]

Front Pharmacol
Philips CA, Theruvath AH, Sreemohan A, Baby A, Jose S, Philips M, Philip T, Ramesh C.   +7 more
europepmc   +1 more source

Simulated Body Fluids for Dental Implant Corrosion: A Practical Guide. [PDF]

Dent J (Basel)
Bordbar-Khiabani A.
europepmc   +1 more source

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Meloxicam. [PDF]

Molecules
Guan A, Bei X, Jin C, Xie J, Guo J, Li X.   +5 more
europepmc   +1 more source

Development of in vitro-in vivo correlation for establishing patient-centric quality standards of dissolution for lamotrigine extended-release tablets. [PDF]

Eur J Pharm Biopharm
Zidan A, Siddique AB, Shaklah M, Anand O, O'Connor T, Ashraf M.   +5 more
europepmc   +1 more source

Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions. [PDF]

Mol Pharm
Arora S, Pepin X, Jamei M, Sharma P, Heimbach T, Wagner C, Bransford P, Kollipara S, Ahmed T, Hingle M, Dallmann A, Scherholz M, Stamatis SD, Cano-Vega M, Mistry N, Tannergren C, Borges L, Lindahl A, Rullo G, Mackie C, Mitra A, Kushner J, Harish Jain KM, Polli JE.   +23 more
europepmc   +1 more source

Dose Accuracy and Content Uniformity of Low-Dose Metoprolol Tablets: 3D Printing Compared with Tablet Splitting in Hospital Pharmacy Setting. [PDF]

Pharmaceutics
Larsen C, Shokraneh F, Lahtinen J, Bahman M, Mantila L, Hrižanovská L, Sandler N.   +6 more
europepmc   +1 more source

Model-Integrated Bioequivalence (MIBE) in Generic Drug Research: Can We Ease the Bioequivalence Burden? [PDF]

Pharmaceutics
Kollipara S, Boddu R, Uppuluri CT, Saini AK.   +3 more
europepmc   +1 more source