Journal Issue: AAPS J Volume 18(3);  2016 May

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Journal List

Volume 18(3);  2016 May

Review Articles

Regulator of G-protein Signaling (RGS)1 and RGS10 Proteins as Potential Drug Targets for Neuroinflammatory and Neurodegenerative Diseases
Jae-Kyung Lee, Josephine Bou Dagher
AAPS J. 2016 May; 18(3): 545–549. Published online 2016 Feb 22. doi: 10.1208/s12248-016-9883-4
PMCID:
PMC5256602
Abstract Article PDF–287K
Regulator of G Protein Signaling 17 as a Negative Modulator of GPCR Signaling in Multiple Human Cancers
Michael P. Hayes, David L. Roman
AAPS J. 2016 May; 18(3): 550–559. Published online 2016 Feb 29. doi: 10.1208/s12248-016-9894-1
PMCID:
PMC5256612
Abstract Article PDF–486K
RGS6 as a Novel Therapeutic Target in CNS Diseases and Cancer
Katelin E. Ahlers, Bandana Chakravarti, Rory A. Fisher
AAPS J. 2016 May; 18(3): 560–572. Published online 2016 Mar 22. doi: 10.1208/s12248-016-9899-9
PMCID:
PMC5256616
Abstract Article PDF–792K
Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling
Robert N. Schuck, Joseph A. Grillo
AAPS J. 2016 May; 18(3): 573–577. Published online 2016 Feb 24. doi: 10.1208/s12248-016-9891-4
PMCID:
PMC5256609
Abstract Article PDF–253K
Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications
Sandra Suarez-Sharp, Poonam R. Delvadia, Angelica Dorantes, John Duan, Anna Externbrink, Zongming Gao, Tapash Ghosh, Sarah Pope Miksinski, Paul Seo
AAPS J. 2016 May; 18(3): 578–588. Published online 2016 Feb 29. doi: 10.1208/s12248-016-9893-2
PMCID:
PMC5256611
Abstract Article PDF–604K
Gut Wall Metabolism. Application of Pre-Clinical Models for the Prediction of Human Drug Absorption and First-Pass Elimination
Christopher R. Jones, Oliver J. D. Hatley, Anna-Lena Ungell, Constanze Hilgendorf, Sheila Annie Peters, Amin Rostami-Hodjegan
AAPS J. 2016 May; 18(3): 589–604. Published online 2016 Mar 10. doi: 10.1208/s12248-016-9889-y
PMCID:
PMC5256607
Abstract Article PDF–769K

Mini-Reviews

Recent Advances in Application of Pharmacogenomics for Biotherapeutics
Pramod B. Mahajan
AAPS J. 2016 May; 18(3): 605–611. Published online 2016 Mar 23. doi: 10.1208/s12248-016-9903-4
PMCID:
PMC5256619
Abstract Article PDF–390K
BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements
Barbara M. Davit, Isadore Kanfer, Yu Chung Tsang, Jean-Michel Cardot
AAPS J. 2016 May; 18(3): 612–618. Published online 2016 Mar 4. doi: 10.1208/s12248-016-9877-2
PMCID:
PMC5256598
Abstract Article PDF–308K

Research Articles

Evaluating In Vivo-In Vitro Correlation Using a Bayesian Approach
Junshan Qiu, Marilyn Martinez, Ram Tiwari
AAPS J. 2016 May; 18(3): 619–634. Published online 2016 Feb 19. doi: 10.1208/s12248-016-9880-7
PMCID:
PMC5256600
Abstract Article PDF–788K
Determination of Cellular Processing Rates for a Trastuzumab-Maytansinoid Antibody-Drug Conjugate (ADC) Highlights Key Parameters for ADC Design
Katie F. Maass, Chethana Kulkarni, Alison M. Betts, K. Dane Wittrup
AAPS J. 2016 May; 18(3): 635–646. Published online 2016 Feb 24. doi: 10.1208/s12248-016-9892-3
PMCID:
PMC5256610
Abstract Article PDF–1008K
Controlled Release of Chitosan and Sericin from the Microspheres-Embedded Wound Dressing for the Prolonged Anti-microbial and Wound Healing Efficacy
Pornanong Aramwit, Rungnapha Yamdech, Sumate Ampawong
AAPS J. 2016 May; 18(3): 647–658. Published online 2016 Mar 2. doi: 10.1208/s12248-016-9897-y
PMCID:
PMC5256614
Abstract Article PDF–1.0M
Reserpine Inhibit the JB6 P+ Cell Transformation Through Epigenetic Reactivation of Nrf2-Mediated Anti-oxidative Stress Pathway
Bo Hong, Zhengyuan Su, Chengyue Zhang, Yuqing Yang, Yue Guo, Wenjing Li, Ah-Ng Tony Kong
AAPS J. 2016 May; 18(3): 659–669. Published online 2016 Mar 17. doi: 10.1208/s12248-016-9901-6
PMCID:
PMC5256618
Abstract Article PDF–753K
Analytical Similarity Assessment in Biosimilar Studies
Shein-Chung Chow, Fuyu Song, He Bai
AAPS J. 2016 May; 18(3): 670–677. Published online 2016 Feb 12. doi: 10.1208/s12248-016-9882-5
PMCID:
PMC5256601
Abstract Article PDF–340K
The Population Pharmacokinetics of d-β-hydroxybutyrate Following Administration of (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate
Vittal Shivva, Pete J. Cox, Kieran Clarke, Richard L. Veech, Ian G. Tucker, Stephen B. Duffull
AAPS J. 2016 May; 18(3): 678–688. Published online 2016 Feb 18. doi: 10.1208/s12248-016-9879-0
PMCID:
PMC5256599
Abstract Article PDF–808K
Aggregation Kinetics for IgG1-Based Monoclonal Antibody Therapeutics
A. Singla, R. Bansal, Varsha Joshi, Anurag S. Rathore
AAPS J. 2016 May; 18(3): 689–702. Published online 2016 Feb 22. doi: 10.1208/s12248-016-9887-0
PMCID:
PMC5256606
Abstract Article PDF–857K
Establishing the Quantitative Relationship Between Lanreotide Autogel®, Chromogranin A, and Progression-Free Survival in Patients with Nonfunctioning Gastroenteropancreatic Neuroendocrine Tumors
Núria Buil-Bruna, Marion Dehez, Amandine Manon, Thi Xuan Quyen Nguyen, Iñaki F. Trocóniz
AAPS J. 2016 May; 18(3): 703–712. Published online 2016 Feb 23. doi: 10.1208/s12248-016-9884-3
PMCID:
PMC5256603
Abstract Article PDF–892K
Pharmacodynamic Model of Hepcidin Regulation of Iron Homeostasis in Cynomolgus Monkeys
Wojciech Krzyzanski, Jim J. Xiao, Barbra Sasu, Beth Hinkle, Juan Jose Perez-Ruixo
AAPS J. 2016 May; 18(3): 713–727. Published online 2016 Feb 25. doi: 10.1208/s12248-016-9886-1
PMCID:
PMC5256605
Abstract Article PDF–968K
Pediatric Biopharmaceutical Classification System: Using Age-Appropriate Initial Gastric Volume
Ramzi Shawahna
AAPS J. 2016 May; 18(3): 728–736. Published online 2016 Mar 2. doi: 10.1208/s12248-016-9885-2
PMCID:
PMC5256604
Abstract Article PDF–360K
Preclinical Pharmacokinetics Study of R- and S-Enantiomers of the Histone Deacetylase Inhibitor, AR-42 (NSC 731438), in Rodents
Hao Cheng, Zhiliang Xie, William P. Jones, Xiaohui Tracey Wei, Zhongfa Liu, Dasheng Wang, Samuel K. Kulp, Jiang Wang, Christopher C. Coss, Ching-Shih Chen, Guido Marcucci, Ramiro Garzon, Joseph M. Covey, Mitch A. Phelps, Kenneth K. Chan
AAPS J. 2016 May; 18(3): 737–745. Published online 2016 Mar 4. doi: 10.1208/s12248-016-9876-3
PMCID:
PMC5256597
Abstract Article PDF–515K
Does the Systemic Plasma Profile Inform the Liver Profile? Analysis Using a Physiologically Based Pharmacokinetic Model and Individual Compounds
Rui Li, Tristan S. Maurer, Kevin Sweeney, Hugh A. Barton
AAPS J. 2016 May; 18(3): 746–756. Published online 2016 Mar 7. doi: 10.1208/s12248-016-9895-0
PMCID:
PMC5256613
Abstract Article PDF–1.4M
Use of the Biopharmaceutics Drug Disposition Classification System (BDDCS) to Help Predict the Occurrence of Idiosyncratic Cutaneous Adverse Drug Reactions Associated with Antiepileptic Drug Usage
Rosa Chan, Chun-yu Wei, Yuan-tsong Chen, Leslie Z. Benet
AAPS J. 2016 May; 18(3): 757–766. Published online 2016 Mar 7. doi: 10.1208/s12248-016-9898-x
PMCID:
PMC5256615
Abstract Article PDF–583K
Development of a Physiologically Based Pharmacokinetic Model to Predict Disease-Mediated Therapeutic Protein–Drug Interactions: Modulation of Multiple Cytochrome P450 Enzymes by Interleukin-6
Xiling Jiang, Yanli Zhuang, Zhenhua Xu, Weirong Wang, Honghui Zhou
AAPS J. 2016 May; 18(3): 767–776. Published online 2016 Mar 9. doi: 10.1208/s12248-016-9890-5
PMCID:
PMC5256608
Abstract Article PDF–754K
A Kinetic Degradation Study of Curcumin in Its Free Form and Loaded in Polymeric Micelles
Ornchuma Naksuriya, Mies J. van Steenbergen, Javier S. Torano, Siriporn Okonogi, Wim E. Hennink
AAPS J. 2016 May; 18(3): 777–787. Published online 2016 Apr 1. doi: 10.1208/s12248-015-9863-0
PMCID:
PMC5256596
Abstract Article PDF–566K

Brief/Technical Note

Tissue Penetration of a Novel Spectinamide Antibiotic for the Treatment of Tuberculosis
Dora Babu Madhura, Ashit Trivedi, Jiuyu Liu, Vincent A. Boyd, Cynthia Jeffries, Vivian Loveless, Richard E. Lee, Bernd Meibohm
AAPS J. 2016 May; 18(3): 788–791. Published online 2016 Mar 16. doi: 10.1208/s12248-016-9900-7
PMCID:
PMC5256617
Abstract Article PDF–344K

Erratum

Erratum to: Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?
Dorys Argelia Diaz, Stephen T. Colgan, Connie S. Langer, Nagesh Bandi, Michael D. Likar, Leslie Van Alstine
AAPS J. 2016 May; 18(3): 792. Published online 2015 Nov 4. doi: 10.1208/s12248-015-9835-4
Corrects:
AAPS J. 2016 Jan; 18(1): 15–22.
PMCID:
PMC5256595
Correction PDF–101K
Articles from The AAPS Journal are provided here courtesy of American Association of Pharmaceutical Scientists