Volume 15; Issue 4

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The AAPS Journal
Volume 15; Issue 4

The AAPS Journal

Volume 15; Issue 4

1

International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

Davit, Barbara, Braddy, April C., Conner, Dale P., Yu, Lawrence X.

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 303 KB

english, 2013

2

Meeting Report: Metabolites in Safety Testing (MIST) Symposium—Safety Assessment of Human Metabolites: What’s REALLY Necessary to Ascertain Exposure Coverage in Safety Tests?

Gao, Hongying, Jacobs, Abigail, White, Ronald E., Booth, Brian P., Obach, R. Scott

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 148 KB

english, 2013

3

Physiologically Based Pharmacokinetic Modelling of Drug Penetration Across the Blood–Brain Barrier—Towards a Mechanistic IVIVE-Based Approach

Ball, Kathryn, Bouzom, FranÃ§ois, Scherrmann, Jean-Michel, Walther, Bernard, DeclÃ¨ves, Xavier

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 797 KB

english, 2013

4

A Simplified PBPK Modeling Approach for Prediction of Pharmacokinetics of Four Primarily Renally Excreted and CYP3A Metabolized Compounds During Pregnancy

Xia, Binfeng, Heimbach, Tycho, Gollen, Rakesh, Nanavati, Charvi, He, Handan

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 556 KB

english, 2013

5

A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms

Zajicek, Anne, Fossler, Michael J., Barrett, Jeffrey S., Worthington, Jeffrey H., Ternik, Robert, Charkoftaki, Georgia, Lum, Susan, Breitkreutz, JÃ¶rg, Baltezor, Mike, Macheras, Panos, Khan, Mansoor,

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 1016 KB

english, 2013

6

Impact of Osmotically Active Excipients on Bioavailability and Bioequivalence of BCS Class III Drugs

Chen, Mei-Ling, Sadrieh, Nakissa, Yu, Lawrence

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 261 KB

english, 2013

7

Immunogenicity of Subcutaneously Administered Therapeutic Proteins—a Mechanistic Perspective

Fathallah, Anas M., Bankert, Richard B., Balu-Iyer, Sathy V.

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 218 KB

english, 2013

8

First Characterization of AKB-48 Metabolism, a Novel Synthetic Cannabinoid, Using Human Hepatocytes and High-Resolution Mass Spectrometry

Gandhi, Adarsh S., Zhu, Mingshe, Pang, Shaokun, Wohlfarth, Ariane, Scheidweiler, Karl B., Liu, Hua-fen, Huestis, Marilyn A.

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 598 KB

english, 2013

9

Epigenetic Cancer Prevention Mechanisms in Skin Cancer

Saha, Kamalika, Hornyak, Thomas J., Eckert, Richard L.

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 208 KB

english, 2013

10

Effects of Selected OATP and/or ABC Transporter Inhibitors on the Brain and Whole-Body Distribution of Glyburide

Tournier, Nicolas, Saba, Wadad, Cisternino, Salvatore, Peyronneau, Marie-Anne, Damont, Annelaure, Goutal, SÃ©bastien, Dubois, Albertine, DollÃ©, FrÃ©dÃ©ric, Scherrmann, Jean-Michel, Valette, HÃ©ric, K

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 338 KB

english, 2013

11

Functional Analysis of Novel Polymorphisms in the HumanSLCO1A2Gene that Encodes the Transporter OATP1A2

Fanfan Zhou, Jian Zheng, Ling Zhu, Andreas Jodal, Pei H. Cui, Mark Wong…

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 540 KB

english, 2013

12

Population Pharmacodynamic Modeling of Hyperglycemic Clamp and Meal Tolerance Tests in Patients with Type 2 Diabetes Mellitus

Ying Hong, Jasper Dingemanse, Patricia Sidharta, Donald E. Mager

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 884 KB

english, 2013

13

Multiple Imputation of Missing Covariates in NONMEM and Evaluation of the Method’s Sensitivity to η-Shrinkage

Åsa M. Johansson, Mats O. Karlsson

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 281 KB

english, 2013

14

Quantification of Swelling and Erosion in the Controlled Release of a Poorly Water-Soluble Drug Using Synchrotron X-ray Computed Microtomography

Xianzhen Yin, Haiyan Li, Zhen Guo, Li Wu, Fangwei Chen, Marcel de Matas…

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 732 KB

english, 2013

15

Intraperitoneal Injection of Clodronate Liposomes Eliminates Visceral Adipose Macrophages and Blocks High-fat Diet-induced Weight Gain and Development of Insulin Resistance

Le Bu, Mingming Gao, Shen Qu, Dexi Liu

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 691 KB

english, 2013

16

Perspectives on the Role of Isoflavones in Prostate Cancer

Aamir Ahmad, Bernhard Biersack, Yiwei Li, Bin Bao, Dejuan Kong…

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 243 KB

english, 2013

17

Silica Colloidal Crystals as Emerging Materials for High-Throughput Protein Electrophoresis

Nadine K. Njoya, Robert E. Birdsall, Mary J. Wirth

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 549 KB

english, 2013

18

Phytochemicals from Cruciferous Vegetables, Epigenetics, and Prostate Cancer Prevention

Gregory W. Watson, Laura M. Beaver, David E. Williams…

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 410 KB

english, 2013

19

Emerging Applications of Metabolomics in Studying Chemopreventive Phytochemicals

Lei Wang, Chi Chen

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 476 KB

english, 2013

20

Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop

Jane R. Kenny, Maggie M. Liu, Andrew T. Chow, Justin C. Earp…

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 404 KB

english, 2013

21

Population Pharmacokinetics of Cyclosporine in Transplant Recipients

Kelong Han, Venkateswaran C. Pillai, Raman Venkataramanan

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 300 KB

english, 2013

22

Mass Spectrometry-Based Targeted Proteomics as a Tool to Elucidate the Expression and Function of Intestinal Drug Transporters

Oswald, Stefan, GrÃ¶er, Christian, Drozdzik, Marek, Siegmund, Werner

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 668 KB

english, 2013

23

Incorporation of Physiologically Based Pharmacokinetic Modeling in the Evaluation of Solubility Requirements for the Salt Selection Process: A Case Study Using Phenytoin

Chiang, Po-Chang, Wong, Harvey

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 417 KB

english, 2013

24

Comparison of Methods for Handling Missing Covariate Data

Johansson, Åsa M., Karlsson, Mats O.

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 383 KB

english, 2013

25

Structure Activity Relationships in Alkylammonium C12-Gemini Surfactants Used as Dermal Permeation Enhancers

Silva, Sérgio M. C., Sousa, João J. S., Marques, Eduardo F., Pais, Alberto A. C. C., Michniak-Kohn, Bozena B.

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 518 KB

english, 2013

26

Effect of PEG Surface Conformation on Anticancer Activity and Blood Circulation of Nanoemulsions Loaded with Tocotrienol-Rich Fraction of Palm Oil

Alayoubi, Alaadin, Alqahtani, Saeed, Kaddoumi, Amal, Nazzal, Sami

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 529 KB

english, 2013

27

Impact of Genetic Polymorphism on Drug-Drug Interactions Mediated by Cytochromes: A General Approach

Tod, Michel, Nkoud-Mongo, Christina, Gueyffier, François

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 309 KB

english, 2013

28

Flow Imaging Microscopy for Protein Particle Analysis—A Comparative Evaluation of Four Different Analytical Instruments

Zölls, Sarah, Weinbuch, Daniel, Wiggenhorn, Michael, Winter, Gerhard, Friess, Wolfgang, Jiskoot, Wim, Hawe, Andrea

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 770 KB

english, 2013

29

Novel Hybrid GPU–CPU Implementation of Parallelized Monte Carlo Parametric Expectation Maximization Estimation Method for Population Pharmacokinetic Data Analysis

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 250 KB

english, 2013

30

A Mathematical Model of the Effect of Immunogenicity on Therapeutic Protein Pharmacokinetics

Chen, Xiaoying, Hickling, Timothy, Kraynov, Eugenia, Kuang, Bing, Parng, Chuenlei, Vicini, Paolo

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 964 KB

english, 2013

31

2012 AAPS National Biotech Conference Open Forum: A Perspective on the Current State of Immunogenicity Prediction and Risk Management

Rajadhyaksha, Manoj, Subramanyam, Meena, Rup, Bonnie

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 150 KB

english, 2013

32

Statistical and Bioanalytical Considerations for Establishing a Depletion Criterion for Specificity Testing During Immunogenicity Assessment of a Biotherapeutic

Driscoll, R. O., Zhou, L., Moxness, M., Mytych, D., Chirmule, N., Jawa, V.

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 311 KB

english, 2013

33

Radionuclide Decorporation: Matching the Biokinetics of Actinides by Transdermal Delivery of Pro-chelators

Zhang, Yong, Sadgrove, Matthew P., Mumper, Russell J., Jay, Michael

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 269 KB

english, 2013

34

A Markov Chain Model to Evaluate the Effect ofCYP3A5andABCB1Polymorphisms on Adverse Events Associated with Tacrolimus in Pediatric Renal Transplantation

Sy, Sherwin K. B., Heuberger, Jules, Shilbayeh, Sireen, Conrado, Daniela J., Derendorf, Hartmut

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 283 KB

english, 2013

35

Stable Isotope Dilution Mass Spectrometry for Membrane Transporter Quantitation

Farrokhi, Vahid, McShane, Adam J., Nemati, Reza, Yao, Xudong

Journal:

The AAPS Journal

Year:

2013

Language:

english

File:

PDF, 339 KB

english, 2013