Works matching IS 15507416 AND DT 2022 AND VI 24 AND IP 3

Results: 25

Model for Long Acting Injectables (Depot Formulation) Based on Pharmacokinetics and Physical Chemical Properties.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00695-0

By:

Shah, Jaymin C.;
Hong, Jinyang

Publication type:

Article

Biomarker Assay Validation by Mass Spectrometry.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00707-z

By:

Fernández-Metzler, Carmen;
Ackermann, Brad;
Garofolo, Fabio;
Arnold, Mark E.;
DeSilva, Binodh;
Gu, Huidong;
Laterza, Omar;
Mao, Yan;
Rose, Mark;
Vazvaei-Smith, Faye;
Steenwyk, Rick

Publication type:

Article

A General Biphasic Bodyweight Model for Scaling Basal Metabolic Rate, Glomerular Filtration Rate, and Drug Clearance from Birth to Adulthood.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00716-y

By:

Hu, Teh-Min

Publication type:

Article

A Fit-for-Purpose Method to Measure Circulating Levels of the mRNA Component of a Liposomal-Formulated Individualized Neoantigen-Specific Therapy for Cancer.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00709-x

By:

Guelman, Sebastian;
Zhou, Ying;
Brady, Ann;
Peng, Kun

Publication type:

Article

When to Extend Monitoring of Anti-drug Antibodies for High-risk Biotherapeutics in Clinical Trials: an Opinion from the European Immunogenicity Platform.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00712-2

By:

Lotz, Gregor P.;
Benstein, Karin;
Bloem, Karien;
Buddiger, Harm;
Calonder, Claudio;
Elm, Stefanie;
Fernandez, Elena;
Goodman, Joanne;
Gorovits, Boris;
Grudzinska-Goebel, Joanna;
Janssen, Melody;
Jawa, Vibha;
Kramer, Daniel;
Luo, Linlin;
Malisauskas, Mantas;
Michaut, Lydia;
Schäfer, Martin;
Spindeldreher, Sebastian;
Ullmann, Martin;
Nana Weldingh, Karin

Publication type:

Article

Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00708-y

By:

Hays, Amanda;
Amaravadi, Lakshmi;
Fernandez-Metzler, Carmen;
King, Lindsay;
Mathews, Joel;
Ni, Yan;
Quadrini, Karen;
Tinder, Chunyan;
Vazvaei, Faye;
Zeng, Jianing

Publication type:

Article

Correction: Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories.

Published in:

2022

By:

Hays, Amanda;
Islam, Rafiq;
Matys, Katie;
Williams, Dave

Publication type:

Correction Notice

An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00683-4

By:

Anderson, Melanie;
Dockendorf, Marissa F.;
McIntosh, Ian;
Xie, Iris;
Breidinger, Sheila;
Meng, Dongfang;
Ren, Sumei;
Zhong, Wendy;
Zhang, Li;
Roadcap, Brad;
Bateman, Kevin P.;
Stone, Julie;
Woolf, Eric

Publication type:

Article

Application of Modeling and Simulation to Identify a Shortened Study Duration and Novel Bioequivalence Metric for a Long-Acting Intrauterine System.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00715-z

By:

Sharan, Satish;
Choi, Sungwoo;
Zou, Yuan;
Wang, Yan;
Kim, Myong-Jin;
Fang, Lanyan;
Choi, Stephanie;
Makhlouf, Fairouz;
Grosser, Stella C.;
Zhang, Xinyuan;
Zhao, Liang

Publication type:

Article

Does Food Affect the Pharmacokinetics of Non-orally Delivered Drugs? A Review of Currently Available Evidence.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00714-0

By:

Zou, Peng

Publication type:

Article

A Critical Overview of the Biological Effects of Excipients (Part II): Scientific Considerations and Tools for Oral Product Development.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00713-1

By:

Martinez, Marilyn N.;
Wu, Fang;
Sinko, Balint;
Brayden, David J.;
Grass, Michael;
Kesisoglou, Filippos;
Stewart, Aaron;
Sugano, Kiyohiko

Publication type:

Article

A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00711-3

By:

Martinez, Marilyn N.;
Sinko, Balint;
Wu, Fang;
Flanagan, Talia;
Borbás, Enikő;
Tsakalozou, Eleftheria;
Giacomini, Kathleen M.

Publication type:

Article

Tumor Growth Inhibition-Overall Survival (TGI-OS) Model for Subgroup Analysis Based on Post-Randomization Factors: Application for Anti-drug Antibody (ADA) Subgroup Analysis of Atezolizumab in the IMpower150 Study.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00710-4

By:

Yoshida, Kenta;
Chan, Phyllis;
Marchand, Mathilde;
Zhang, Rong;
Wu, Benjamin;
Ballinger, Marcus;
Sternheim, Nitzan;
Jin, Jin Y.;
Bruno, René

Publication type:

Article

Machine Learning Prediction of Clinical Trial Operational Efficiency.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00703-3

By:

Wu, Kevin;
Wu, Eric;
DAndrea, Michael;
Chitale, Nandini;
Lim, Melody;
Dabrowski, Marek;
Kantor, Klaudia;
Rangi, Hanoor;
Liu, Ruishan;
Garmhausen, Marius;
Pal, Navdeep;
Harbron, Chris;
Rizzo, Shemra;
Copping, Ryan;
Zou, James

Publication type:

Article

International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00702-4

By:

Keire, David A.;
Bream, Robert;
Wollein, Uwe;
Schmaler-Ripcke, Jeannette;
Burchardt, Annette;
Conti, Massimiliano;
Zmysłowski, Adam;
Keizers, Peter;
Morin, Justin;
Poh, Jalene;
George, Mark;
Wierer, Michael

Publication type:

Article

Effect of the Size of Protein Therapeutics on Brain Pharmacokinetics Following Systematic Administration.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00701-5

By:

Chang, Hsueh-Yuan;
Wu, Shengjia;
Li, Yinyi;
Guo, Leiming;
Li, Yuelin;
Shah, Dhaval K.

Publication type:

Article

The AAPS Journal Theme Issue: Rising Stars in Drug Delivery and Novel Carriers.

Published in:

2022

By:

Salem, Aliasger K.;
Nguyen, Juliane;
Ainslie, Kristy M.

Publication type:

Editorial

An IQ Consortium Perspective on Connecting Dissolution Methods to In Vivo Performance: Analysis of an Industrial Database and Case Studies to Propose a Workflow.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00699-w

By:

Aburub, Aktham;
Chen, Yuan;
Chung, John;
Gao, Ping;
Good, David;
Hansmann, Simone;
Hawley, Michael;
Heimbach, Tycho;
Hingle, Martin;
Kesisoglou, Filippos;
Li, Rong;
Rose, John;
Tisaert, Christophe

Publication type:

Article

Targeted Delivery of Endosomal Escape Peptides to Enhance Immunotoxin Potency and Anti-cancer Efficacy.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00698-x

By:

Polli, Joseph Ryan;
Chen, Ping;
Bordeau, Brandon M.;
Balthasar, Joseph P.

Publication type:

Article

DISSOLUTION PROFILE SIMILARITY ANALYSES—STATISTICAL PRINCIPLES, METHODS AND CONSIDERATIONS.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00697-y

By:

Hoffelder, Thomas;
Leblond, David;
Van Alstine, Leslie;
Diaz, Dorys Argelia;
Suarez-Sharp, Sandra;
Witkowski, Krista;
Altan, Stan;
Reynolds, James;
Bergeron, Zachary;
Lief, Kevin;
Zheng, Yanbing;
Abend, Andreas

Publication type:

Article

Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00696-z

By:

Yeoh, Thean;
Ma, Lisa;
Badruddoza, Abu Zayed;
Shah, Jaymin;
Zhang, Shawn

Publication type:

Article

Population Pharmacodynamic Modeling of Eflornithine-Based Treatments Against Late-Stage Gambiense Human African Trypanosomiasis and Efficacy Predictions of L-eflornithine-Based Therapy.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00693-2

By:

Amilon, Carl;
Boberg, Mikael;
Tarning, Joel;
Äbelö, Angela;
Ashton, Michael;
Jansson-Löfmark, Rasmus

Publication type:

Article

Current Approaches for Dissolution Similarity Assessment, Requirements, and Global Expectations.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00691-4

By:

Abend, Andreas M.;
Zhang, Limin;
Fredro-Kumbaradzi, Emilija;
Hoffelder, Thomas;
Cohen, Michael J.;
Anand, Om;
Delvadia, Poonam;
Mandula, Haritha;
Zhang, Zhen;
Kotzagiorgis, Evangelos;
Lum, Susan;
Pereira, Victor Gomes;
Barker, Amy;
Lavrich, David;
Kraemer, Johannes;
Sharp-Suarez, Sandra

Publication type:

Article

A Model-Based Approach to Bridging Plasma and Dried Blood Spot Concentration Data for Phase 3 Verubecestat Trials.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-022-00682-5

By:

Dockendorf, Marissa F.;
Jaworowicz, David;
Humphrey, Rebecca;
Anderson, Melanie;
Breidinger, Sheila;
Ma, Lei;
Taylor, Theresa;
Dupre, Nicole;
Jones, Christopher;
Furtek, Christine;
Kantesaria, Bhavna;
Bateman, Kevin P.;
Woolf, Eric;
Egan, Michael F.;
Stone, Julie A.

Publication type:

Article

In Vitro Assessment of Transporter Mediated Perpetrator DDIs for Several Hepatitis C Virus Direct-Acting Antiviral Drugs and Prediction of DDIs with Statins Using Static Models.

Published in:

AAPS Journal, 2022, v. 24, n. 3, p. 1, doi. 10.1208/s12248-021-00677-8

By:

Chu, Xiaoyan;
Chan, Grace Hoyee;
Houle, Robert;
Lin, Meihong;
Yabut, Jocelyn;
Fandozzi, Christine

Publication type:

Article