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