Works matching IS 15507416 AND DT 2023 AND VI 25 AND IP 1

Results: 25

Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00787-5

By:

Kourentas, Alexandros;
Gajewska, Monika;
Lin, Wen;
Dhareshwar, Sundeep S.;
Steib-Lauer, Caroline;
Kulkarni, Swarupa;
Hirsch, Stefan;
Heimbach, Tycho;
Mueller-Zsigmondy, Martin

Publication type:

Article

A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA’s Benefit-Risk Framework.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00789-3

By:

Mutanga, Jane Namangolwa;
Nukala, Ujwani;
Rodriguez Messan, Marisabel;
Yogurtcu, Osman N.;
McCormick, Quinn;
Sauna, Zuben E.;
Whitaker, Barbee I.;
Forshee, Richard A.;
Yang, Hong

Publication type:

Article

Best Practices in mAb and Soluble Target Assay Selection for Quantitative Modelling and Qualitative Interpretation.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00788-4

By:

Fairman, David;
Tang, Huaping

Publication type:

Article

Vinyl Sulfone-functionalized Acetalated Dextran Microparticles as a Subunit Broadly Acting Influenza Vaccine.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00786-6

By:

Batty, Cole J.;
Lifshits, Liubov M.;
Hendy, Dylan A.;
Eckshtain-Levi, Meital;
Ontiveros-Padilla, Luis A.;
Carlock, Michael A.;
Ross, Ted M.;
Bachelder, Eric M.;
Ainslie, Kristy M.

Publication type:

Article

The Development and Characterization of a Highly Sensitive Mature TGFβ3 Assay to Evaluate Anti-TGFβ3 Target Engagement.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00785-7

By:

Setiadi, A. Francesca;
Sperinde, Gizette;
Cheu, Melissa;
Liang, Wei-Ching;
Lin, WeiYu;
Mahood, Connie;
Fischer, Saloumeh K.

Publication type:

Article

A Novel Neutralization Antibody Assay Method to Overcome Drug Interference with Better Compatibility with Acid-Sensitive Neutralizing Antibodies.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00783-9

By:

Wickramarachchi, Dilki;
Wagner, Julianne;
Woo, Thomas;
Ferrari, Federico;
Steinmetz, Thomas;
Helmy, Roy;
Xu, Weifeng

Publication type:

Article

Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00781-x

By:

Belenos, Avery;
Wood, Erin Leigh;
Hu, Meng;
Kozak, Darby;
Xu, Xiaoming;
Fisher, Adam C.

Publication type:

Article

Theoretical Examination Seeking Tangible Physical Meanings of Slopes and Intercepts of Plasma Concentration–Time Relationships in Minimal Physiologically Based Pharmacokinetic Models.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00779-x

By:

Jeong, Yoo-Seong;
Jusko, William J.

Publication type:

Article

Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00782-w

By:

Chen, Kang;
Smith, Cameron J.

Publication type:

Article

Model-Informed Approach Supporting Approval of Nexviazyme (Avalglucosidase Alfa-ngpt) in Pediatric Patients with Late-Onset Pompe Disease.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-023-00784-8

By:

Li, Ruo-Jing;
Ma, Lian;
Drozda, Katarzyna;
Wang, Jie;
Punnoose, Ann R.;
Jeng, Linda J. B.;
Maynard, Janet W.;
Zhu, Hao;
Pacanowski, Michael

Publication type:

Article

Correction: End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics.

Published in:

2023

By:

Morales, Annette Medina;
Sreedhara, Alavattam;
Buecheler, Jakob;
Brosig, Sebastian;
Chou, Danny;
Christian, Twinkle;
Das, Tapan;
de Jong, Isabella;
Fast, Jonas;
Jagannathan, Bharat;
Moussa, Ehab M.;
Nejadnik, M. Reza;
Prajapati, Indira;
Radwick, Allison;
Rahman, Yusra;
Singh, Shubhadra

Publication type:

Correction Notice

Pancreatic Hormone Insulin Modulates Organic Anion Transporter 1 in the Kidney: Regulation via Remote Sensing and Signaling Network.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00778-y

By:

Yu, Zhou;
Zhang, Jinghui;
Liang, Zhengxuan;
Wu, Jingjing;
Liu, Kexin;
You, Guofeng

Publication type:

Article

Lessons from CDER’s Quality Management Maturity Pilot Programs.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00777-z

By:

Maguire, Jennifer;
Fisher, Adam;
Harouaka, Djamila;
Rakala, Nandini;
Lundi, Carla;
Yambot, Marcus;
Viehmann, Alex;
Stiber, Neil;
Gonzalez, Kevin;
Canida, Lyle;
Buhse, Lucinda;
Kopcha, Michael

Publication type:

Article

Development and Validation of a Western Blot Method to Quantify Mini-Dystrophin in Human Skeletal Muscle Biopsies.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00776-0

By:

Soderstrom, Catherine I.;
Larsen, Jennifer;
Owen, Carolina;
Gifondorwa, David;
Beidler, David;
Yong, Florence H.;
Conrad, Patricia;
Neubert, Hendrik;
Moore, Steven A.;
Hassanein, Mohamed

Publication type:

Article

Development of a Near-Infrared Spectroscopy (NIRS)–Based Characterization Approach for Inherent Powder Blend Heterogeneity in Direct Compression Formulations.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00775-1

By:

Shi, Zhenqi;
Rao, Kallakuri Suparna;
Thool, Prajwal;
Kuhn, Robert;
Thomas, Rekha;
Rich, Sharyl;
Mao, Chen

Publication type:

Article

Addressing the Accuracy of Plasma Protein Binding Measurement for Highly Bound Compounds Using the Dilution Method.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00774-2

By:

Ryu, Sangwoo;
Tess, David;
Di, Li

Publication type:

Article

End-to-End Approach to Surfactant Selection, Risk Mitigation, and Control Strategies for Protein-Based Therapeutics.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00773-3

By:

Sreedhara, Alavattam;
Buecheler, Jakob;
Brosig, Sebastian;
Chou, Danny;
Christian, Twinkle;
Das, Tapan;
de Jong, Isabella;
Fast, Jonas;
Jagannathan, Bharat;
Morales, Annette Medina;
Moussa, Ehab M.;
Nejadnik, M. Reza;
Prajapati, Indira;
Radwick, Allison;
Rahman, Yusra;
Singh, Shubhadra

Publication type:

Article

Monoclonal Antibody Pharmacokinetics in Cynomolgus Monkeys Following Subcutaneous Administration: Physiologically Based Model Predictions from Physiochemical Properties.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00772-4

By:

Hu, Shihao;
Datta-Mannan, Amita;
D'Argenio, David Z.

Publication type:

Article

Pharmacokinetics of Long-Acting Aqueous Nano-/Microsuspensions After Intramuscular Administration in Different Animal Species and Humans—a Review.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00771-5

By:

Nguyen, Vy Thi Thanh;
Darville, Nicolas;
Vermeulen, An

Publication type:

Article

ACUVRA: Anion-Exchange Chromatography UV-Ratio Analysis—A QC-Friendly Method for Monitoring Adeno-Associated Virus Empty Capsid Content To Support Process Development and GMP Release Testing.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00768-0

By:

Frenkel, Ruth;
Tribby, Dana;
Boumajny, Boris;
Larson, Nicholas;
Sampson, Matthew;
Barney, Christopher;
Bergelson, Svetlana;
Sosic, Zoran;
Yeung, Bernice

Publication type:

Article

Stability and Function of Extracellular Vesicles Derived from Immortalized Human Corneal Stromal Stem Cells: A Proof of Concept Study.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00767-1

By:

Lyu, Ning;
Knight, Robert;
Robertson, Sarah Y. T.;
Dos Santos, Aurelie;
Zhang, Chi;
Ma, Chao;
Xu, Jianjiang;
Zheng, Jie;
Deng, Sophie X.

Publication type:

Article

Preclinical Observations of Systemic and Ocular Antidrug Antibody Response to Intravitreally Administered Drugs.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00766-2

By:

Wessels, Uwe;
Zadak, Markus;
Weidmann, Anja Manuela;
Stuchly, Thomas;
Stubenrauch, Kay-Gunnar

Publication type:

Article

A Simple One-Parameter Percent Dissolved Versus Time Dissolution Equation that Accommodates Sink and Non-sink Conditions via Drug Solubility and Dissolution Volume.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00765-3

By:

Polli, James E.

Publication type:

Article

Overcoming Biopharmaceutical Interferents for Quantitation of Host Cell DNA Using an Automated, High-Throughput Methodology.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00764-4

By:

Lauro, Mackenzie L.;
Bowman, Amy M.;
Smith, Joseph P.;
Gaye, Susannah N.;
Acevedo-Skrip, Jillian;
DePhillips, Pete A.;
Loughney, John W.

Publication type:

Article

Challenges and Strategies for Solubility Measurements and Dissolution Method Development for Amorphous Solid Dispersion Formulations.

Published in:

AAPS Journal, 2023, v. 25, n. 1, p. 1, doi. 10.1208/s12248-022-00760-8

By:

Hermans, Andre;
Milsmann, Johanna;
Li, Hanlin;
Jede, Christian;
Moir, Andrea;
Hens, Bart;
Morgado, James;
Wu, Tian;
Cohen, Michael

Publication type:

Article