Results 31 to 40 of about 455 (133)

Advances in Nasal Biopharmaceutics to Support Product Development and Therapeutic Needs [PDF]

Pharmaceutics
Background/Objectives: Nasal biopharmaceutics is the scientific understanding of product and patient factors that determine the rate and extent of drug exposure following nasal administration. The authors considered whether current biopharmaceutics tools
Ben Forbes, Lucy Goodacre, Alison B. Lansley, Andrew R. Martin, Helen Palmer, Claire Patterson, Chris Roe, Regina Scherließ   +7 more
doaj   +2 more sources

Physiologically-Based Biopharmaceutics Modeling for Ibuprofen: Identifying Key Formulation Parameter and Virtual Bioequivalence Assessment [PDF]

Pharmaceutics
Background: Physiologically based pharmacokinetic (PBPK) modeling for biopharmaceutics applications (i.e., physiologically based biopharmaceutics modeling (PBBM)) enables mechanistic modeling from dissolution to absorption and disposition, facilitating ...
Javier Zarzoso-Foj, Marina Cuquerella-Gilabert, Matilde Merino-Sanjuan, Javier Reig-Lopez, Víctor Mangas-Sanjuán, Alfredo Garcia-Arieta   +5 more
doaj   +2 more sources

In Vivo Predictive Dissolution and Biopharmaceutic-Based In Silico Model to Explain Bioequivalence Results of Valsartan, a Biopharmaceutics Classification System Class IV Drug [PDF]

Pharmaceutics
The purpose of this study was to predict the in vivo bioequivalence (BE) outcome of valsartan (VALS, BCS class IV) from three oral-fixed combination products with hydrochlorothiazide (HCTZ, BCS class III) (Co-Diovan® Forte as reference and two generic ...
Isabel Gonzalez-Alvarez, Alejandro Ruiz-Picazo, Ruben Selles-Talavera, Andres Figueroa-Campos, Virginia Merino, Marival Bermejo, Marta Gonzalez-Alvarez   +6 more
doaj   +2 more sources

Bile micelle binding of structurally diverse ionized drug molecules [PDF]

ADMET and DMPK
Background and purpose: Predicting the food effect on oral drug absorption by physiologically based biopharmaceutical modelling (PBBM) remains challenging.
Mayu Konishi, Kiyohiko Sugano
doaj   +2 more sources

Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook [PDF]

Pharmaceuticals
Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product. However, bioequivalence studies represent significant complexities due to the interplay of multiple factors related to ...
Sivacharan Kollipara, Frederico Severino Martins, Rebeka Jereb, Dejan Krajcar, Tausif Ahmed   +4 more
doaj   +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

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

Mol Pharm
Pharmaceutical innovators and generic companies use Physiologically Based Biopharmaceutics Models (PBBMs) to guide drug product development and potentially waive clinical pharmacokinetic studies for both pre- and post-approval changes.
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   +2 more sources

Prediction and Prognostication of Peripheral Blood Biomarkers in Head and Neck Cutaneous Squamous Cell Carcinoma. [PDF]

Otolaryngol Head Neck Surg
Abstract Objective While many with head and neck cutaneous squamous cell carcinomas (cHNSCC) respond well to surgery alone, there is a need to refine traditional staging systems. We aim to identify whether peripheral blood biomarkers (PBBMs) may enhance current staging for prognostication and adjuvant treatment selection.
Hubbard MG, Chestnut EH, Bhaskara MC, Chen LW, Kennedy E, Lee A, Yesensky J, Farlow JL.   +7 more
europepmc   +2 more sources

Physiologically Based Biopharmaceutics Modeling (PBBM)

, 2021
Manuel Ibarra, Alejandra Schiavo, Lawrence J. Lesko   +2 more
openaire   +2 more sources

Subcutaneous Biopharmaceutics: Building tools for a flexible future

British Journal of Pharmacy, 2023
The major biopharmaceutics challenge faced during the development of subcutaneous (SC) drug products is the limited understanding of the physiological factors and the combination product attributes that can impact absorption rate/extent and drug product ...
Kate Louise Harris , J Matthew Wood , Laura Garcia Gonzalez, Simon Todd, Iain Grant   +4 more
doaj   +1 more source