Results 31 to 40 of about 773 (143)

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

Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration. [PDF]

Pharmaceuticals (Basel)
The pharmaceutical industry has faced significant changes in recent years, primarily influenced by regulatory standards, market competition, and the need to accelerate drug development.
Djuris J, Cvijic S, Djekic L.
europepmc   +3 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

The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development [PDF]

Arhiv za farmaciju, 2021
Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) emerged as a ...
Cvijić Sandra, Ignjatović Jelisaveta, Parojčić Jelena, Ibrić Svetlana   +3 more
doaj   +1 more source

Emerging perspectives on leveraging physiologically based biopharmaceutics modeling (PBBM) for BCS class III biowaivers: A webinar summary. [PDF]

J Pharm Sci
Fang L, Veerasingham S, Xu Y, Garcia-Arieta A, Kollipara S, Kanagasabapathy Y, Ahmed T, Martins FS, Suarez-Sharp S.   +8 more
europepmc   +2 more sources

Harnessing Open-Source Solutions: Insights From the First Open Systems Pharmacology (OSP) Community Conference. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT In 2017, the free and open‐source software Open Systems Pharmacology (OSP) was launched. Since then, OSP has evolved from a small community into a diverse network of stakeholders committed to advancing open‐source solutions for model‐informed drug development (MIDD). In this context, the first OSP Community Conference was hosted by Novartis in
Dallmann A, Feick D, Balazki P, Benamara S, Burghaus R, Chenel M, Choi SL, Cordes H, Guimarães M, Hamadeh A, Ince I, Job KM, Kanacher T, Kovar A, Kuepfer L, Lippert J, Macente J, Nauwelaerts N, Niederalt C, Peters S, Proença S, Sato M, Schaller S, Schlender JF, Schneider A, Sjögren E, Solodenko J, Staab A, Vrenken P, Wendl T, de Witte WEA, Teutonico D.   +31 more
europepmc   +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

Uptake of long-chain fatty acids from the bone marrow suppresses CD8⁺ T-cell metabolism and function in multiple myeloma [PDF]

, 2023
T cells demonstrate impaired function in multiple myeloma (MM) but suppressive mechanisms in the bone marrow microenvironment remain poorly defined. We observe that bone marrow CD8+ T-cell function is decreased in MM compared with controls, and is also ...
Basu, Supratik, Bishop, Emma L, Cribbs, Adam P, Dimeloe, Sarah, Escribano-Gonzalez, Cristina, Foster, Kane, Fulton-Ward, Taylor, Giles, Hannah, Gudgeon, Nancy, James-Bott, Anna, Jayawardana, Dedunu, Karim, Farheen, Mahmood, Ansar, Munford, Haydn, Pratt, Guy, Tennant, Daniel A   +15 more
core   +1 more source

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

CPT: Pharmacometrics &Systems Pharmacology, Volume 12, Issue 5, Page 585-597, May 2023., 2023
Abstract This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG). The aims of this
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong‐Jin Kim, Jianghong Fan, Banu S. Zolnik, Duxin Sun, Yi Zhang, Liang Zhao   +17 more
wiley   +1 more source

Peripheral lymphocytes and lactate dehydrogenase correlate with response and survival in head and neck cancers treated with immune checkpoint inhibitors

Cancer Medicine, Volume 12, Issue 8, Page 9384-9391, April 2023., 2023
Abstract Background Little is known regarding associations between peripheral blood biomarkers (PBBMs) and survival, response, and toxicity in recurrent/metastatic head and neck squamous cell carcinomas (R/M HNSCC) treated with immune checkpoint inhibitors (ICIs). Methods In this single‐institution retrospective cohort study, a dataset of patients with
Cassie Pan, Qian Vicky Wu, Jenna Voutsinas, Jeffrey J. Houlton, Brittany Barber, Zain H. Rizvi, Emily Marchiano, Neal Futran, George E. Laramore, Jay J. Liao, Upendra Parvathaneni, Renato G. Martins, Jonathan R. Fromm, Cristina P. Rodriguez   +13 more
wiley   +1 more source