Volume 22; Issue 2

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The AAPS Journal
Volume 22; Issue 2

The AAPS Journal

Volume 22; Issue 2

1

The Production, Quality Control, and Characterization of ZED8, a CD8-Specific 89Zr-Labeled Immuno-PET Clinical Imaging Agent

Gill, Herman, Seipert, Richard, Carroll, Vincent M., Gouasmat, Alexandra, Yin, Jian, Ogasawara, Annie, de Jong, Isabella, Phan, Minh Michael, Wang, Xiangdan, Yang, Jihong, Ilovich, Ohad, Marik, Jan, W

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 2.75 MB

2020

2

Criteria to Reevaluate Anti-drug Antibody Assay Cut Point Suitability in the Target Population

Tan, Charles Y., Steeno, Gregory S, You, Zhiping, Gaitonde, Puneet, Cai, Chun-Hua, Kamerud, John, Gorovits, Boris, Baltrukonis, Daniel J.

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 301 KB

2020

3

The Evolving Druggability and Developability Space: Chemically Modified New Modalities and Emerging Small Molecules

Yang, Wenzhan, Gadgil, Prajakta, Krishnamurthy, Venkata R., Landis, Margaret, Mallick, Pankajini, Patel, Dipal, Patel, Phenil J., Reid, Darren L., Sanchez-Felix, Manuel

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 1.20 MB

2020

4

Polymeric Nanocarrier Formulations of Biologics Using Inverse Flash NanoPrecipitation

Markwalter, Chester E., Pagels, Robert F., Hejazi, Ava N., Gordon, Akiva G. R., Thompson, Alexandra L., Prud’homme, Robert K.

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 2.77 MB

2020

5

Model-Based Characterization of the Pharmacokinetics, Target Engagement Biomarkers, and Immunomodulatory Activity of PF-06342674, a Humanized mAb Against IL-7 Receptor-α, in Adults with Type 1 Diabetes

Williams, Jason H., Udata, Chandrasekhar, Ganguly, Bishu J., Bucktrout, Samantha L., Joh, Tenshang, Shannon, Megan, Wong, Gilbert Y., Levisetti, Matteo, Garzone, Pamela D., Meng, Xu

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 1.83 MB

2020

6

Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development

Le Merdy, Maxime, Tan, Ming-Liang, Babiskin, Andrew, Zhao, Liang

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 1.92 MB

2020

7

Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays

Boris, Gorovits, Fiscella, Michele, Havert, Mike, Koren, Eugen, Long, Brian, Milton, Mark, Purushothama, Shobha

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 560 KB

english, 2020

8

Expert Discussion of the Role of Rate Constant Versus Clearance Approaches to Define Drug Pharmacokinetics: Theoretical and Clinical Considerations

Martinez, Marilyn N., Jelliffe, Roger W., Proost, Johannes H.

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 341 KB

english, 2020

9

Development of a Population Pharmacokinetics-Based in vitro-in vivo Correlation Model for Drugs with Site-Dependent Absorption: the Acyclovir Case Study

Shin, Soyoung, Kim, Tae Hwan, Lee, Da Young, Chung, Seung Eun, Lee, Jong Bong, Kim, Do-Hyung, Shin, Beom Soo

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 1.52 MB

english, 2020

10

Antibody Coadministration as a Strategy to Overcome Binding-Site Barrier for ADCs: a Quantitative Investigation

Singh, Aman P., Guo, Leiming, Verma, Ashwni, Wong, Gloria Gao-Li, Thurber, Greg M., Shah, Dhaval K.

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 5.56 MB

english, 2020

11

An Agent-Based Systems Pharmacology Model of the Antibody-Drug Conjugate Kadcyla to Predict Efficacy of Different Dosing Regimens

Menezes, Bruna, Cilliers, Cornelius, Wessler, Timothy, Thurber, Greg M., Linderman, Jennifer J.

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 2.40 MB

english, 2020

12

Physiologically Based Pharmacokinetic Modeling and Simulation of Sunitinib in Pediatrics

Yu, Yanke, DuBois, Steven G., Wetmore, Cynthia, Khosravan, Reza

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 1.33 MB

2020

13

Dose Correction for a MichaelisâMenten Approximation of a Target-Mediated Drug Disposition Model with a Multiple Intravenous Dosing Regimens

Yan, Xiaoyu, Ruixo, Juan Jose Perez, Krzyzanski, Wojciech

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 2.70 MB

2020

14

Immunogenicity Risk Assessment for PEGylated Therapeutics

Mora, Johanna R., White, Joleen T., DeWall, Stephen L.

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 359 KB

english, 2020

15

Development and Utility of an ELISA Method for Sensitive and Specific Detection of IgE Antidrug Antibodies

Zhong, Zhandong Don, Jiang, Lynn L., Khandelwal, Puneet, Clarke, Adam W., Bakhtiar, Ray, Zou, Linglong

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 1.41 MB

english, 2020

16

Global Sensitivity Analysis of the Rodgers and Rowland Model for Prediction of Tissue: Plasma Partitioning Coefficients: Assessment of the Key Physiological and Physicochemical Factors That Determine Small-Molecule Tissue Distribution

Yau, Estelle, Olivares-Morales, AndrÃ©s, Gertz, Michael, Parrott, Neil, Darwich, Adam S., Aarons, Leon, Ogungbenro, Kayode

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 2.94 MB

2020

17

Correction to: Recommendations for the Development of Cell-Based Anti-Viral Vector Neutralizing Antibody Assays

Gorovits, Boris, Fiscella, Michele, Havert, Mike, Koren, Eugen, Long, Brian, Milton, Mark, Purushothama, Shobha

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 176 KB

english, 2020

18

Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits

SchÃ¼tz, Helmut, Labes, Detlew, Tomashevskiy, Michael, la Parra, Mario GonzÃ¡lez-de, Shitova, Anastasia, Fuglsang, Anders

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 327 KB

2020

19

Quantification of T Cell Binding Polyclonal Rabbit Anti-thymocyte Globulin in Human Plasma with Liquid Chromatography Tandem-Mass Spectrometry

Amrani, Mohsin El, Admiraal, Rick, Willaert, Lobke, Ebskamp-van Raaij, Lysette J. C., Lacna, Amelia M., Hack, C. Erik, Huitema, Alwin D. R., Nierkens, Stefan, van Maarseveen, Erik M.

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 750 KB

2020

20

Model Averaging in Viral Dynamic Models

GonÃ§alves, Antonio, MentrÃ©, France, Lemenuel-Diot, Annabelle, Guedj, JÃ©rÃ©mie

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 2.12 MB

2020

21

Bayesian Individual Dynamic Predictions with Uncertainty of Longitudinal Biomarkers and Risks of Survival Events in a Joint Modelling Framework: a Comparison Between Stan, Monolix, and NONMEM

Riglet, FranÃ§ois, Mentre, France, Veyrat-Follet, Christine, Bertrand, Julie

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 2.26 MB

english, 2020

22

Demonstrating Contribution of Components of Fixed-Dose Drug Combinations Through Longitudinal Exposure-Response Analysis

NÃ¸hr-Nielsen, AsbjÃ¸rn, Lange, Theis, Forman, Julie Lyng, Papathanasiou, Theodoros, Foster, David J. R., Upton, Richard N., Bjerrum, Ole Jannik, Lund, Trine Meldgaard

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 5.13 MB

english, 2020

23

Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties: Case StudyâHypromellose (HPMC)

Zarmpi, P., Flanagan, T., Meehan, E., Mann, J., Fotaki, N.

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 4.08 MB

english, 2020

24

Physiologically Based Pharmacokinetic Modeling and Tissue Distribution Characteristics of SHetA2 in Tumor-Bearing Mice

Sharma, Ankur, Li, Mengjie, Thavathiru, Elangovan, Ibrahim, Mariam, Garcia-Contreras, Lucila, Benbrook, Doris M, Woo, Sukyung

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 1004 KB

english, 2020

25

Development of an Aerosol Dose Collection Apparatus for In Vitro Dissolution Measurements of Orally Inhaled Drug Products

Price, Robert, Shur, Jagdeep, Ganley, William, Farias, GonÃ§alo, Fotaki, Nikoletta, Conti, Denise S., Delvadia, Renishkumar, Absar, Mohammad, Saluja, Bhawana, Lee, Sau

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 2.18 MB

english, 2020

26

Systematic Review of Device Parameters and Design of Studies Bridging Biologic-Device Combination Products Using Prefilled Syringes and Autoinjectors

Hu, Ping, Wang, Jie, Florian, Jeffery, Shatzer, Katherine, Stevens, Alan M., Gertz, Jacqueline, Ji, Ping, Huang, Shiew Mei, Zineh, Issam, Wang, Yow-Ming C.

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 452 KB

english, 2020

27

Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. Case Study: Superdisintegrants

Zarmpi, Panagiota, Flanagan, Talia, Meehan, Elizabeth, Mann, James, Fotaki, Nikoletta

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 4.30 MB

2020

28

Mechanistic Pharmacokinetic/Pharmacodynamic Model of Sunitinib and Dopamine in MCF-7/Adr Xenografts: Linking Cellular Heterogeneity to Tumour Burden

Wang, Siyuan, Zhu, Xiao, Han, Mengyi, Hao, Fangran, Lu, Wei, Zhou, Tianyan

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 2.96 MB

2020

29

A Microfluidic Perfusion Platform for In Vitro Analysis of Drug Pharmacokinetic-Pharmacodynamic (PK-PD) Relationships

Guerrero, Yadir A., Desai, Diti, Sullivan, Connor, Kindt, Erick, Spilker, Mary E., Maurer, Tristan S., Solomon, Deepak E., Bartlett, Derek W.

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 1.74 MB

2020

30

Co-administration of Paediatric Medicines with Food and Drinks in the Context of Their Physicochemical Propertiesâa Global Perspective on Practices and Recommendations

Martir, Joana, Flanagan, Talia, Mann, James, Fotaki, Nikoletta

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 833 KB

2020

31

Investigation on the Effect of Capillary Microsampling on Hematologic and Toxicokinetic Evaluation in Regulatory Safety Studies in Mice

Wang, Bonnie, Wang, Linna, Batog, Alicja, Brodie, Thomas, Ramaiah, Lila, Chadwick, Kristina D., Su, Ting, Mangipudy, Raja, Pilutla, Renuka C., Ji, Qin C.

Journal:

The AAPS Journal

Year:

2020

File:

PDF, 556 KB

2020

32

Development of a Cell-Based Assay for the Detection of Neutralizing Antibodies to PF-06730512 Using Homogenous Time-Resolved Fluorescence

Luong, Michael, Wang, Ying, Berasi, Stephen P., Buhlmann, Janet E., Yang, Hongying, Gorovits, Boris

Journal:

The AAPS Journal

Year:

2020

Language:

english

File:

PDF, 1.20 MB

english, 2020

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