Works matching IS 15507416 AND DT 2024 AND VI 26 AND IP 1

Results: 25

Taurine, a Naturally Occurring Amino Acid, as a Physical Stability Enhancer of Different Monoclonal Antibodies.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00893-y

By:

Sreenivasan, Shravan;
Rathore, Anurag S.

Publication type:

Article

Successful Development of Nonclinical Anti-Drug Antibody Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00891-0

By:

Arjomandi, Audrey;
Siradze, Ketevan;
Cheu, Melissa;
Davancaze, Teresa;
Yadav, Rajbharan;
Rao, Gautham K.;
Wong, Lisa;
Fischer, Saloumeh K.

Publication type:

Article

Agreement Between a Colorimetric Assay and Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry for Quantifying Paracetamol Plasma Concentrations.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00890-1

By:

Edwina, Angela Elma;
Dreesen, Erwin;
Hias, Julie;
Koch, Birgit C. P.;
Van den Eede, Nele;
Pauwels, Steven;
Allegaert, Karel;
Van der Linden, Lorenz;
Spriet, Isabel;
Tournoy, Jos

Publication type:

Article

An Explanation of Why Dose-Corrected Area Under the Curve for Alternate Administration Routes Can Be Greater than for Intravenous Dosing.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00887-w

By:

Wakuda, Hirokazu;
Xiang, Yue;
Sodhi, Jasleen K.;
Uemura, Naoto;
Benet, Leslie Z.

Publication type:

Article

Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00883-6

By:

Arrington, Leticia;
Karlsson, Mats O.

Publication type:

Article

Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00892-z

By:

Liu, Veronica;
McGrath, Kelly;
Albert, Josh;
Mayer, Andrew P.;
Busz, Maria;
Birchler, Mary;
Tang, Huaping;
Jiang, Yong

Publication type:

Article

Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00880-9

By:

Hays, Amanda;
Wissel, Mark;
Colletti, Kelly;
Soon, Russell;
Azadeh, Mitra;
Smith, Justin;
Doddareddy, Rajitha;
Chalfant, Melanie;
Adamowicz, Wendy;
Ramaswamy, Swarna Suba;
Dholakiya, Sanjay L.;
Guelman, Sebastian;
Gullick, Bryan;
Durham, Jennifer;
Rennier, Keith;
Nagilla, Pruthvi;
Muruganandham, Anamica;
Diaz, Manisha;
Tierney, Cassandra;
John, Kaarthik

Publication type:

Article

Connexin-Containing Vesicles for Drug Delivery.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00889-8

By:

Hanafy, Mahmoud S.;
Cui, Zhengrong

Publication type:

Article

Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00888-9

By:

Saadeddin, Anas;
Purohit, Vivek;
Huh, Yeamin;
Wong, Mei;
Maulny, Aurelia;
Dowty, Martin E.;
Sagawa, Kazuko

Publication type:

Article

Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00886-x

By:

Wu, Fang;
Mousa, Youssef;
Jereb, Rebeka;
Batchelor, Hannah;
Chakraborty, Sumon;
Heimbach, Tycho;
Stier, Ethan;
Kesisoglou, Filippos;
Kollipara, Sivacharan;
Zhang, Lei;
Zhao, Liang

Publication type:

Article

Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-024-00885-y

By:

Gong, Yuqing;
Barretto, Francis-Xavier;
Tsong, Yi;
Mousa, Youssef;
Ren, Ke;
Kozak, Darby;
Shen, Meiyu;
Hu, Meng;
Zhao, Liang

Publication type:

Article

Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00884-5

By:

Tsakalozou, Eleftheria;
Fang, Lanyan;
Bi, Youwei;
van den Heuvel, Michiel;
Ahmed, Tausif;
Tsang, Yu Chung;
Lionberger, Robert;
Rostami-Hodjegan, Amin;
Zhao, Liang

Publication type:

Article

Building a Predictive PBPK Model for Human OATP Substrates: a Strategic Framework for Early Evaluation of Clinical Pharmacokinetic Variations Using Pitavastatin as an Example.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00882-7

By:

Liang, Xiaomin;
Koleske, Megan L.;
Yang, Jesse;
Lai, Yurong

Publication type:

Article

Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00879-2

By:

Walenga, Ross L.;
Babiskin, Andrew H.;
Bhoopathy, Sid;
Clarke, James F.;
De Backer, Jan;
Ducharme, Murray;
Kelly, Marc;
Le Merdy, Maxime;
Yoon, Miyoung;
Roy, Partha

Publication type:

Article

A Bispecific Modeling Framework Enables the Prediction of Efficacy, Toxicity, and Optimal Molecular Design of Bispecific Antibodies Targeting MerTK.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00881-8

By:

Li, Ran;
Dere, Edward;
Kwong, Mandy;
Fei, Mingjian;
Dave, Rutwij;
Masih, Shabkhaiz;
Wang, Joy;
McNamara, Erin;
Huang, Haochu;
Liang, Wei-Ching;
Schutt, Leah;
Kamath, Amrita V.;
Ovacik, Meric A.

Publication type:

Article

Novel Selective Quantification of Zinpentraxin Alfa Biotherapeutic in the Presence of Endogenous Isomer in Plasma Samples of Idiopathic Pulmonary Fibrosis Patients Using Immunoaffinity LC–MS.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00878-3

By:

Li, Maoyin;
Arjomandi, Audrey;
Sun, Xiaowei;
Lu, Erhu;
Tyagi, Tulika;
Lin, WeiYu;
Fischer, Saloumeh K.;
Kaur, Surinder;
Xu, Keyang

Publication type:

Article

Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00877-4

By:

Stafford, Michelle;
Dunn, Rachel Linck;
Gupta, Nirzari;
Kakarla, Raghavi;
Kirkpatrick, Douglas;
Magparangalan, Daniel;
Ngo, Diem;
Gryniewicz-Ruzicka, Connie;
Smith, Anjanette;
Stark, Matthew;
Ye, Wei;
Yilmaz, Huzeyfe;
Woodruff, Jeffrey;
Manibusan, Mary;
Stiber, Neil;
Viehmann, Alex

Publication type:

Article

Design, Synthesis, and Biochemical Analysis of a Molecule Designed to Enhance Endosomal Escape.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00876-5

By:

Jadhav, Satish G.;
Setten, Ryan L.;
Medina, Carlos;
Cui, Xian-Shu;
Dowdy, Steven F.

Publication type:

Article

Notes on the Use of Kirchhoff's Laws in Pharmacokinetics.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00875-6

By:

Siegel, Ronald A.

Publication type:

Article

Pharmacodynamics of Cyclin D1 Degradation in Ovarian Cancer Xenografts with Repeated Oral SHetA2 Dosing.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00874-7

By:

Sharma, Ankur;
Liu, Xin;
Chandra, Vishal;
Rai, Rajani;
Benbrook, Doris M.;
Woo, Sukyung

Publication type:

Article

Therapeutic Fusion Proteins.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00873-8

By:

Marsh, Morgan C.;
Owen, Shawn C.

Publication type:

Article

Correction: A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications.

Published in:

2024

By:

Rajan, Shiny Amala Priya;
Sherfey, Jason;
Ohri, Shivam;
Nichols, Lauren;
Smith, J. Tyler;
Parekh, Paarth;
Kadar, Eugene P.;
Clark, Frances;
George, Billy T.;
Gregory, Lauren;
Tess, David;
Gosset, James R.;
Liras, Jennifer;
Geishecker, Emily;
Obach, R. Scott;
Cirit, Murat

Publication type:

Correction Notice

Correction to: Immunoinformatic Risk Assessment of Host Cell Proteins During Process Development for Biologic Therapeutics.

Published in:

2024

By:

Haltaufderhyde, Kirk;
Roberts, Brian J.;
Khan, Sundos;
Terry, Frances;
Boyle, Christine M.;
McAllister, Mitchell;
Martin, William;
Rosenberg, Amy;
De Groot, Anne S.

Publication type:

Correction Notice

Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00866-7

By:

Kramer, Hester;
Bicer, Ceyhun;
Otoul, Christian;
Rospo, Chiara;
Macpherson, Merran;
Watling, Mark;
Bani, Massimo;
Sciberras, David;
Chanteux, Hugues

Publication type:

Article

A Population Model of Time-Dependent Changes in Serum Creatinine in (Near)term Neonates with Hypoxic-Ischemic Encephalopathy During and After Therapeutic Hypothermia.

Published in:

AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00851-0

By:

Krzyzanski, Wojciech;
Wintermark, Pia;
Annaert, Pieter;
Groenendaal, Floris;
Şahin, Suzan;
Öncel, Mehmet Yekta;
Armangil, Didem;
Koc, Esin;
Battin, Malcolm R.;
Gunn, Alistair J.;
Frymoyer, Adam;
Chock, Valerie Y.-L.;
Keles, Elif;
Mekahli, Djalila;
van den Anker, John;
Smits, Anne;
Allegaert, Karel

Publication type:

Article