Works matching IS 15507416 AND DT 2024 AND VI 26 AND IP 5

Results: 19

ICH M10 Bioanalytical Method Validation Guideline-1 year Later.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00974-y

By:

Vazvaei-Smith, Faye;
Wickremsinhe, Enaksha;
Woolf, Eric;
Yu, Chongwoo

Publication type:

Article

Design of Auto-Adaptive Drug Delivery System for Effective Delivery of Peptide Drugs to Overcoming Mucus and Epithelial Barriers.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00971-1

By:

Ding, Ruihuan;
Li, Yanping;
Zheng, Wei;
Sun, Yiying;
Zhao, Zhenyu;
Zhang, Houqian;
Yuan, Ranran;
Wang, Aiping;
Sun, Kaoxiang;
Wang, Hongbo;
Shi, Yanan

Publication type:

Article

Letter to the Editor on “Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies”.

Published in:

2024

By:

Sun, Wanjie;
Alosh, Mohamed;
Schuirmann, Donald J.;
Grosser, Stella

Publication type:

Letter

A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00968-w

By:

Nøhr, Mark Klitgaard;
Waheed, Shaik Rizwan;
Kildemoes, Rasmus Juul;
Hatorp, Vibeke;
Bækdal, Tine Aggerholm;
Adrian, Charlotte Lindorff;
Korsholm, Lars Peter;
Arp-Hansen, Eva Lisby;
Holst, Helle;
Roberts, Scott W.

Publication type:

Article

Liposomal Formulations of Anti-Alzheimer Drugs and siRNA for Nose-to-Brain Delivery: Design, Safety and Efficacy In Vitro.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00967-x

By:

Lee, David;
Shen, Andrew M;
Garbuzenko, Olga B;
Minko, Tamara

Publication type:

Article

Predicting Tumor Volume Doubling Time and Progression-Free Survival in Untreated Patients from Patient-Derived-Xenograft (PDX) Models: A Translational Model-Based Approach.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00960-4

By:

Tosca, E. M.;
Ronchi, D.;
Rocchetti, M.;
Magni, P.

Publication type:

Article

Best Practices for Development and Validation of Enzymatic Activity Assays to Support Drug Development for Inborn Errors of Metabolism and Biomarker Assessment.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00966-y

By:

Azadeh, Mitra;
Good, Jeremy;
Gunsior, Michele;
Kulagina, Nadia;
Lu, Yanmei;
McNally, Jim;
Myler, Heather;
Ni, Yan G.;
Pelto, Ryan;
Quadrini, Karen J.;
Vrentas, Catherine;
Yang, Lin

Publication type:

Article

A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions.

Published in:

2024

By:

Gu, Tianshu;
Wang, Guiying;
van den Oord, Edwin J. C.;
Goldman, Emanuel;
Yang, Chengyuan;
Xie, Ning;
Yao, Lan;
Wang, Cong-Yi;
Jablonski, Monica;
Ray, Kunal;
Liu, Fengxia;
Pan, Wensen;
Flores, Gonzalo;
Aleya, Lotfi;
Meng, Xia;
Jiao, Yan;
Li, Minghui;
Wang, Yongjun;
Gu, Weikuan

Publication type:

Letter

The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00963-1

By:

Khalid, Kanwal;
Lim, Hui Xuan;
Hwang, Jung Shan;
Poh, Chit Laa

Publication type:

Article

Modeling Metformin and Dapagliflozin Pharmacokinetics in Chronic Kidney Disease.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00962-2

By:

Shahidehpour, Andrew;
Rashid, Mudassir;
Askari, Mohammad Reza;
Ahmadasas, Mohammad;
Abdel-Latif, Mahmoud;
Fritschi, Cynthia;
Quinn, Lauretta;
Reutrakul, Sirimon;
Bronas, Ulf G.;
Cinar, Ali

Publication type:

Article

Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00961-3

By:

Marden, Stacey;
Campbell, John M.;
Adams, Neal;
Coelho, Ronan;
Foti, Chris;
Franca, Juçara Ribeiro;
Hostyn, Steven;
Huang, Zongyun;
Ultramari, Mariah;
Zelesky, Todd;
Baertschi, Steven W.

Publication type:

Article

Correction to: Neutralizing Antibody Sample Testing and Report Harmonization.

Published in:

2024

By:

Jani, Darshana;
Gunsior, Michele;
Marsden, Robin;
Cowan, Kyra J.;
Irvin, Susan C.;
Hay, Laura Schild;
Ward, Bethany;
Armstrong, Luke;
Azadeh, Mitra;
Cao, Liching;
Carmean, Rebecca;
DelCarpini, Jason;
Dholakiya, Sanjay L.;
Hays, Amanda;
Hosback, Sarah;
Hu, Zheng;
Kulagina, Nadia;
Kumar, Seema;
Lai, Ching Ha;
Lichtfuss, Marit

Publication type:

Correction Notice

A Data Driven Strategy and Case Study for Implementation of Singlicate Analysis in Ligand Binding Assays Used for PK Quantitation.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00959-x

By:

Qu, Qiang;
Liu, Susana;
You, Zhiping;
Steeno, Gregory S.;
Dyleski, Lisa A.;
Mu, Xue;
Wang, Ying;
Baltrukonis, Daniel

Publication type:

Article

An Investigation of In Vitro Anti-Cancer Efficacy of Dihydroartemisinin-Loaded Bovine Milk Exosomes Against Triple-Negative Breast Cancer.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00958-y

By:

Kumar, Dulla Naveen;
Chaudhuri, Aiswarya;
Shiromani, Udita;
Kumar, Dinesh;
Agrawal, Ashish Kumar

Publication type:

Article

Blood–Brain Barrier Permeability is Affected by Changes in Tight Junction Protein Expression at High-Altitude Hypoxic Conditions—this may have Implications for Brain Drug Transport.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00957-z

By:

Liu, Guiqin;
Wang, Qian;
Tian, Lu;
Wang, Mengyue;
Duo, Delong;
Duan, Yabin;
Lin, Yue;
Han, Junjun;
Jia, Qiangqiang;
Zhu, Junbo;
Li, Xiangyang

Publication type:

Article

Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00953-3

By:

Karsten, Carley;
Grannas, Karin;
Bergman, Oskar;
Movérare, Robert;
Roforth, Matthew;
Willrich, Maria Alice V.;
Snyder, Melissa R.;
Yang, Yifei K.

Publication type:

Article

Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00948-0

By:

Friedman, Erica L.;
Falade, Leah W.;
Bartlett, Michael G.

Publication type:

Article

Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00946-2

By:

Kinhikar, Arvind;
Hassanein, Mohamed;
Harman, Jake;
Soderstrom, Catherine;
Honrine, Kimberly;
Lavelle, Amy;
Valentin, Marie-Anne;
Mathews, Joel

Publication type:

Article

Non-Invasive, Continuous, Quantitative Detection of Solvent Content in Vacuum Tray Drying.

Published in:

AAPS Journal, 2024, v. 26, n. 5, p. 1, doi. 10.1208/s12248-024-00944-4

By:

Louge, Michel Y.;
Mandur, Jasdeep;
Grigorov, Plamen;
Blincoe, William;
Lamberto, David;
Bower, Colton;
Meyer, Robert F.

Publication type:

Article