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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
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
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
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
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
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
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
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
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
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

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