Works matching IS 15507416 AND DT 2023 AND VI 25 AND IP 4

Results: 21

A PKPD Case Study: Achieving Clinically Relevant Exposures of AZD5991 in Oncology Mouse Models.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00836-z
By:
- White, Michael J.;
- Cheatham, Letitia;
- Wen, Shenghua;
- Scarfe, Graeme;
- Cidado, Justin;
- Reimer, Corinne;
- Hariparsad, Niresh;
- Jones, Rhys D. O.;
- Drew, Lisa;
- McGinnity, Dermot F.;
- Vasalou, Christina
Publication type:
Article
Lipid Nanoparticle-Enabled Intracellular Delivery of Prime Editors.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00833-2
By:
- Herrera-Barrera, Marco;
- Gautam, Milan;
- Lokras, Abhijeet;
- Vlasova, Kseniia;
- Foged, Camilla;
- Sahay, Gaurav
Publication type:
Article
Mini-PBPK-Based Population Model and Covariate Analysis to Assess the Complex Pharmacokinetics and Pharmacodynamics of RO7449135, an Anti-KLK5/KLK7 Bispecific Antibody in Cynomolgus Monkeys.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00829-y
By:
- Cai, Hao;
- Tao, Xun;
- Shim, Jeongsup;
- Bauer, Rebecca N.;
- Bremer, Meire;
- Bu, Wei;
- LaMar, Jason;
- Basile, Rachel;
- Dere, Edward;
- Nguyen, Tien;
- Laing, Steven;
- Chan, Pamela;
- Yi, Tangsheng;
- Koerber, James T.;
- Sperinde, Gizette;
- Stefanich, Eric
Publication type:
Article
Robust and Adaptive Two-stage Designs in Nonlinear Mixed Effect Models.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00810-9
By:
- Fayette, Lucie;
- Leroux, Romain;
- Mentré, France;
- Seurat, Jérémy
Publication type:
Article
Streamlining Food Effect Assessment — Are Repeated Food Effect Studies Needed? An IQ Analysis.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00822-5
By:
- Kesisoglou, Filippos;
- Basu, Sumit;
- Belubbi, Tejashree;
- Bransford, Philip;
- Chung, John;
- Dodd, Stephanie;
- Dolton, Michael;
- Heimbach, Tycho;
- Kulkarni, Priyanka;
- Lin, Wen;
- Moir, Andrea;
- Parrott, Neil;
- Pepin, Xavier;
- Ren, Xiaojun;
- Sharma, Pradeep;
- Stamatopoulos, Konstantinos;
- Tistaert, Christophe;
- Vaidhyanathan, Shruthi;
- Wagner, Christian;
- Riedmaier, Arian Emami
Publication type:
Article
Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00826-1
By:
- Pawar, Gopal;
- Wu, Fang;
- Zhao, Liang;
- Fang, Lanyan;
- Burckart, Gilbert J.;
- Feng, Kairui;
- Mousa, Youssef M.;
- Al Shoyaib, Abdullah;
- Jones, Marie-Christine;
- Batchelor, Hannah K.
Publication type:
Article
Correction: A Tangeretin Derivative Inhibits the Growth of Human Prostate Cancer LNCaP Cells by Epigenetically Restoring p21 Gene Expression and Inhibiting Cancer Stem-like Cell Proliferation.
Published in:
2023
By:
- Wei, Guor-Jien;
- Chao, Yen-Hsiang;
- Tung, Yen-Chen;
- Wu, Tien-Yuan;
- Su, Zheng-Yuan
Publication type:
Correction Notice
Glucose-Responsive Microgel Comprising Conventional Insulin and Curcumin-Laden Nanoparticles: a Potential Combination for Diabetes Management.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00839-w
By:
- Heyns, Ingrid M.;
- Davis, Garrett;
- Ganugula, Raghu;
- Ravi Kumar, M. N. V.;
- Arora, Meenakshi
Publication type:
Article
Evaluation of the Potential for Drug-Drug Interactions with Inhaled Itraconazole Using Physiologically Based Pharmacokinetic Modelling, Based on Phase 1 Clinical Data.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00828-z
By:
- Bergagnini-Kolev, Mackenzie;
- Kane, Katie;
- Templeton, Ian E.;
- Curran, Aidan K.
Publication type:
Article
An AI Approach to Generating MIDD Assets Across the Drug Development Continuum.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00838-x
By:
- Barrett, Jeffrey S;
- Goyal, Rahul K;
- Gobburu, Jogarao;
- Baran, Szczepan;
- Varshney, Jyotika
Publication type:
Article
Enhanced Pharmacokinetic Bioanalysis of Antibody–drug Conjugates using Hybrid Immunoaffinity Capture and Microflow LC-MS/MS.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00835-0
By:
- Suh, Moo-jin;
- Powers, Joshua B.;
- Daniels, Casey M.;
- Wu, Yuling
Publication type:
Article
Modelling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00831-4
By:
- Karnati, Prajwala;
- Murthy, Aditya;
- Gundeti, Manoj;
- Ahmed, Tausif
Publication type:
Article
Neutralizing Antibody Validation Testing and Reporting Harmonization.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00830-5
By:
- Myler, Heather;
- Pedras-Vasconcelos, João;
- Lester, Todd;
- Civoli, Francesca;
- Xu, Weifeng;
- Wu, Bonnie;
- Vainshtein, Inna;
- Luo, Linlin;
- Hassanein, Mohamed;
- Liu, Susana;
- Ramaswamy, Swarna Suba;
- Mora, Johanna;
- Pennucci, Jason;
- McCush, Fred;
- Lavelle, Amy;
- Jani, Darshana;
- Ambakhutwala, Angela;
- Baltrukonis, Daniel;
- Barker, Breann;
- Carmean, Rebecca
Publication type:
Article
Anti-melanoma Effects of Resiquimod (RSQ) In Vitro and in Combination with Immune Checkpoint Blockade In Vivo.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00824-3
By:
- Tambunlertchai, Supreeda;
- Geary, Sean M.;
- Naguib, Youssef W.;
- Salem, Aliasger K.
Publication type:
Article
Population-Based Pharmacodynamic Modeling of Omalizumab in Pediatric Patients with Moderate to Severe Persistent Inadequately Controlled Allergic Asthma.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00823-4
By:
- Zhu, Rui;
- Wang, Xiaoning;
- Anderson, Eric;
- Deng, Michelle;
- Pivirotto, Scott;
- Jin, Jin;
- Kassir, Nastya;
- Owen, Ryan
Publication type:
Article
Correction: Harmonizing Biopredictive Methodologies Through the Product Quality Research Institute (PQRI) Part I: Biopredictive Dissolution of Ibuprofen and Dipyridamole Tablets.
Published in:
2023
By:
- Tsume, Yasuhiro;
- Ashworth, Lee;
- Bermejo, Marival;
- Cheng, Joan;
- Cicale, Vincent;
- Dressman, Jennifer;
- Fushimi, Masahiro;
- Gonzalez-Alvarez, Isabel;
- Guo, Yiwang;
- Jankovsky, Corinne;
- Lu, Xujin;
- Matsui, Kazuki;
- Patel, Sanjaykumar;
- Sanderson, Natalie;
- Sun, Changquan Calvin;
- Thakral, Naveen K.;
- Yamane, Miki;
- Zöller, Laurin
Publication type:
Correction Notice
Multifaceted Approach for Quantification and Enzymatic Activity of Iduronate-2-Sulfatase to Support Developing Gene Therapy for Hunter Syndrome.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00821-6
By:
- Franchi, Peter M.;
- Kulagina, Nadia;
- Ilinskaya, Anna;
- Hoffpauir, Brian;
- Qian, Mark G.;
- Sugimoto, Hiroshi
Publication type:
Article
Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00820-7
By:
- Gokemeijer, Jochem;
- Wen, Yi;
- Jawa, Vibha;
- Mitra-Kaushik, Shibani;
- Chung, Shan;
- Goggins, Alan;
- Kumar, Seema;
- Lamberth, Kasper;
- Liao, Karen;
- Lill, Jennie;
- Phung, Qui;
- Walsh, Robin;
- Roberts, Brian J.;
- Swanson, Michael;
- Singh, Inderpal;
- Tourdot, Sophie;
- Kroenke, Mark A.;
- Rup, Bonita;
- Goletz, Theresa J.;
- Gupta, Swati
Publication type:
Article
Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00819-0
By:
- Fletcher, Elimika Pfuma;
- Sahre, Martina;
- Hon, Yuen Yi;
- Balakrishnan, Anand;
- Zhou, Lin;
- Sun, Qin;
- Wang, Jie;
- Maxfield, Kimberly;
- Naik, Raajan;
- Huang, Shiew Mei;
- Wang, Yow-Ming C.
Publication type:
Article
Predicting Human Bioavailability of Subcutaneously Administered Monoclonal Antibodies Using Non-human Primate Linear Clearance and Antibody Isoelectric Point.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00818-1
By:
- Zou, Peng
Publication type:
Article
Micellar Encapsulation of Propofol Reduces its Adsorption on Extracorporeal Membrane Oxygenator (ECMO) Circuit.
Published in:
AAPS Journal, 2023, v. 25, n. 4, p. 1, doi. 10.1208/s12248-023-00817-2
By:
- Khurana, Nitish;
- Sünner, Till;
- Hubbard, Oliver;
- Imburgia, Carina;
- Stoddard, Gregory J.;
- Yellepeddi, Venkata;
- Ghandehari, Hamidreza;
- Watt, Kevin M.
Publication type:
Article