Works matching IS 15507416 AND DT 2025 AND VI 27 AND IP 2

Results: 20

Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities – a Workshop Report.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01050-9

By:

Shubow, Sophie;
Gunsior, Michele;
Rosenberg, Amy;
Wang, Yow-Ming;
Altepeter, Tara;
Guinn, Daphne;
Rajabiabhari, Mohsen;
Kotarek, Joseph;
Mould, Diane R.;
Zhou, Honghui;
Cheifetz, Adam S.;
Garces, Sandra;
Chevalier, Rachel;
Gavan, Sean;
Trusheim, Mark R.;
Rispens, Theo;
Bray, Kurtis;
Partridge, Michael A.

Publication type:

Article

Enhancing Efavirenz Bioavailability Via Polymer-Based Buccal Administration: Optimization and Characterization of Nanocrystal-Loaded Dissolving Microneedle Delivery Systems.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01047-4

By:

Khairiyah, Khairiyah;
Asaf, Muh. Bisfain;
Achmad, Nur Afni Annisa;
Tuna, Rachmatya W.;
Kurniawan, Irfan;
Aziz, Anugerah Yaumil Ramadhani;
Mir, Maria;
Domínguez-Robles, Juan;
Millán-Jiménez, Mónica;
Essadki-Aittaji, Ilyas;
Cobo-González, Ana B.;
Aswad, Muhammad;
Rahman, Latifah;
Manggau, Marianti A.;
Aliyah, Aliyah;
Eltayib, Eyman Mohamed;
Permana, Andi Dian

Publication type:

Article

A Facile Way to Enhance the Therapeutic Efficacy of Hydrophobic Drugs via Amorphous Solid Dispersions.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01046-5

By:

Tao, Ning;
Yan, Zihui;
Wang, Xin;
Wang, Yuhui;
Ji, Li;
Qiu, Lin;
Cui, Pengfei;
Wang, Jianhao

Publication type:

Article

Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01044-7

By:

Panse, N.;
Gerk, P. M.

Publication type:

Article

Unraveling Ceftriaxone Dosing: Free Drug Prediction, Threshold Optimization, and Model Validation.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01041-w

By:

Michel, Johnny;
Monti, Francesco;
Lamoureux, Fabien;
Diagouraga, Djibril;
Etienne, Manuel;
Quillard, Muriel;
Molkhou, Camille;
Tamion, Fabienne;
Dahyot, Sandrine;
Petersen, Tania;
Pereira, Tony;
Pestel-Caron, Martine;
Grosjean, Julien;
Duflot, Thomas

Publication type:

Article

AI-Driven Analysis of Drug Marketing Efficiency: Unveiling FDA Approval to Market Release Dynamics.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01039-4

By:

Takefuji, Yoshiyasu

Publication type:

Article

The Role of Enhanced Analytical Procedure Development in Facilitating Post-Approval Changes Via Established Conditions.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01037-6

By:

Kirkpatrick, Douglas;
Gupta, Nirzari;
Gopalaswamy, Ramesh;
Kolhatkar, Rohit;
Hudson-Davis, Morgan;
Keire, David

Publication type:

Article

Bioequivalence of ANDA Data using a Non-Informative Bayesian Procedure (BEST) Compared with the Two One‑Sided t‑Tests (TOST)

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-024-00981-z

By:

Wang, Jing;
Campbell, Gregory;
Lee, Jae H.;
Hu, Meng;
Feng, Kairui;
Chattopadhyay, Somesh;
Zhao, Liang;
Peck, Carl C.

Publication type:

Article

Addressing Clinical Challenges in Aberrant Pharmacokinetics of Biologic Therapeutic Drugs: Investigating Sample Processing Procedure in the Immunoassays.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01036-7

By:

Chen, Yih-Wen;
Davenport, Olinda;
Yu, Nancy;
Melendez, Rachel;
Nugteren, James;
Nijem, Ihsan;
Yan, Weili;
Hendricks, Robert;
Song, Yuan

Publication type:

Article

Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01028-7

By:

Bautista, Manel;
Caille, Seb;
Corredor, Claudia;
Anantharaman, Sankaran;
Bradbury, Joseph;
Chen, Bei;
Eickhoff, W. Mark;
Harmon, Gregory;
Johnson, Mark;
Li, Fasheng;
Keubler, Anja;
Pfund, Laura;
Russell, Alexander;
Sutcliffe, Kevin;
Tridon, Claire

Publication type:

Article

A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01023-y

By:

Pack, Brian W.;
Siegel, Robert W.;
Cornwell, Paul D.;
Ferrante, Andrea;
Roepke, Douglas A.;
Hodsdon, Michael E.;
Malherbe, Laurent;
Carfagna, Mark A.

Publication type:

Article

Cellular Kinetics and Biodistribution of Adoptive T Cell Therapies: from Biological Principles to Effects on Patient Outcomes.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01017-w

By:

Li, Ran;
Grosskopf, Abigail K.;
Joslyn, Louis R.;
Stefanich, Eric Gary;
Shivva, Vittal

Publication type:

Article

Uniform Spray Dried Loxapine Microparticles Potentially for Nasal Delivery: Exploring Discriminatory In Vitro Release Evaluation Methods.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01045-6

By:

Li, Mengyuan;
Nie, Ziwei;
Yan, Shen;
Zhang, Shengyu;
Chen, Xiao Dong;
Wu, Winston Duo

Publication type:

Article

PBPK Modeling to Recommend Nevirapine Dosing in HIV and HIV-TB Co-infected Patients: Leveraging Enzyme Auto-Induction, Drug Interactions, and Ethnic Variability.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01042-9

By:

Ye, Xuexin;
Liu, Feiyan;
Cheng, Zeneng;
Xie, Feifan

Publication type:

Article

Best Practices and Recommendations for Non-Liquid Matrices Bioanalysis.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01033-w

By:

Vazvaei-Smith, Faye;
Li, Wenkui;
Barnaby, Omar S.;
Bhardwaj, Sanjeev;
Dong, Juyao;
Dumont, Carolyne;
Fernández-Metzler, Carmen;
Geist, Brian;
Hassanein, Mohamed;
Hays, Amanda;
Ilinskaya, Anna;
Kadar, Eugene P.;
King, Kris;
Kulagina, Nadia;
Matta, Murali K.;
Midde, Krishna;
Pan, Rina;
Pathania, Divya;
Tarnowski, Thomas;
Tewalt, Eric

Publication type:

Article

Functional Activity and Binding Specificity of Small Ankyrin Repeat Proteins Called Ankyrons Against SARS-CoV-2 Variants.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01043-8

By:

Park, Yun-Jong;
Jankowski, Wojciech;
Hurst, Nicholas C.;
Fry, Jeremy W.;
Schwabe, Nikolai F.;
Tan, Linda C. C.;
Sauna, Zuben E.

Publication type:

Article

From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-Validation.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01038-5

By:

Gu, Mianzhi;
Gehman, Andrew;
Nifong, Brady;
Mayer, Andrew P.;
Li, Vicky;
Birchler, Mary;
Wang, Kai;
Tang, Huaping

Publication type:

Article

Considerations in K<sub>p,uu,brain</sub>-based Strategy for Selecting CNS-targeted Drug Candidates with Sufficient Target Coverage and Substantial Pharmacodynamic Effect.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01035-8

By:

Zou, Ling;
Chien, Huan-Chieh;
Pade, Devendra;
Li, Yanfei;
Nguyen, Minhkhoi;
Bhamidipati, Ravi Kanth;
Wang, Zhe;
Enogieru, Osatohanmwen Jessica;
Wahlstrom, Jan

Publication type:

Article

Estimation of Ganciclovir Exposure in Adults Transplant Patients by Machine Learning.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-025-01034-9

By:

Sayadi, Hamza;
Fromage, Yeleen;
Labriffe, Marc;
Billat, Pierre-André;
Codde, Cyrielle;
Arraki Zava, Selim;
Marquet, Pierre;
Woillard, Jean-Baptiste

Publication type:

Article

In Vitro-In Silico Models to Elucidate Mechanisms of Bile Acid Disposition and Cellular Aerobics in Human Hepatocytes.

Published in:

AAPS Journal, 2025, v. 27, n. 2, p. 1, doi. 10.1208/s12248-024-01010-9

By:

De Vos, Kristof;
Mols, Raf;
Chatterjee, Sagnik;
Huang, Miao-Chan;
Augustijns, Patrick;
Wolters, Justina Clarinda;
Annaert, Pieter

Publication type:

Article