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

Results: 24

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
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
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
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
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
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
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
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
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
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
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
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
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
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