Volume 17; Issue 6

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The AAPS Journal
Volume 17; Issue 6

The AAPS Journal

Volume 17; Issue 6

1

Erratum to: A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

Jiang, Wenlei, Makhlouf, Fairouz, Schuirmann, Donald J., Zhang, Xinyuan, Zheng, Nan, Conner, Dale, Yu, Lawrence X., Lionberger, Robert

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 71 KB

english, 2015

2

An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products

Soares, Kelen Carine Costa, Santos, Gustavo Mendes Lima, Gelfuso, Guilherme M., Gratieri, Tais

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 87 KB

english, 2015

3

Assessment ofIn VivoClinical Product Performance of a Weak Basic Drug by Integration ofIn VitroDissolution Tests and Physiologically Based Absorption Modeling

Ding, Xuan, Gueorguieva, Ivelina, Wesley, James A., Burns, Lee J., Coutant, Carrie A.

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 675 KB

english, 2015

4

A Neutralizing Antibody Assay Based on a Reporter of Antibody-Dependent Cell-Mediated Cytotoxicity

Wu, Yuling, Li, Jia J., Kim, Hyun Jun, Liu, Xu, Liu, Weiyi, Akhgar, Ahmad, Bowen, Michael A., Spitz, Susan, Jiang, Xu-Rong, Roskos, Lorin K., White, Wendy I.

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 2.87 MB

english, 2015

5

Physiologically Based Pharmacokinetic Predictions of Tramadol Exposure Throughout Pediatric Life: an Analysis of the Different Clearance Contributors with Emphasis on CYP2D6 Maturation

T’jollyn, Huybrecht, Snoeys, Jan, Vermeulen, An, Michelet, Robin, Cuyckens, Filip, Mannens, Geert, Van Peer, Achiel, Annaert, Pieter, Allegaert, Karel, Van Bocxlaer, Jan, Boussery, Koen

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 1.66 MB

english, 2015

6

Development of a Generic Anti-PEG Antibody Assay Using BioScale’s Acoustic Membrane MicroParticle Technology

Dong, Huijin, Mora, Johanna R., Brockus, Catherine, Chilewski, Shannon D., Dodge, Robert, Merrifield, Colin, Dickerson, W. Matthew, DeSilva, Binodh

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 832 KB

english, 2015

7

Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges

Wen, Hong, Jung, Huijeong, Li, Xuhong

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 919 KB

english, 2015

8

Novel Redox-Responsive Amphiphilic Copolymer Micelles for Drug Delivery: Synthesis and Characterization

Bae, Jungeun, Maurya, Abhijeet, Shariat-Madar, Zia, Murthy, S. Narasimha, Jo, Seongbong

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 988 KB

english, 2015

9

Comparison of Deconvolution-Based and Absorption Modeling IVIVC for Extended Release Formulations of a BCS III Drug Development Candidate

Kesisoglou, Filippos, Xia, Binfeng, Agrawal, Nancy G. B.

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 1.09 MB

english, 2015

10

A Modeling and Simulation Framework for Adverse Events in Erlotinib-Treated Non-Small-Cell Lung Cancer Patients

Suleiman, Ahmed Abbas, Frechen, Sebastian, Scheffler, Matthias, Zander, Thomas, Nogova, Lucia, Kocher, Martin, Jaehde, Ulrich, Wolf, Jürgen, Fuhr, Uwe

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 768 KB

english, 2015

11

2D-Cosy NMR Spectroscopy as a Quantitative Tool in Biological Matrix: Application to Cyclodextrins

Dufour, Gilles, Evrard, Brigitte, de Tullio, Pascal

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 946 KB

english, 2015

12

Therapeutic Applications of Curcumin Nanoformulations

M. M. Yallapu, P. K. B. Nagesh, M. Jaggi, S. C. Chauhan

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 989 KB

english, 2015

13

Haste Makes Waste: The Interplay Between Dissolution and Precipitation of Supersaturating Formulations

D. D. Sun, P. I. Lee

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 1.87 MB

english, 2015

14

An Extended Minimal Physiologically Based Pharmacokinetic Model: Evaluation of Type II Diabetes Mellitus and Diabetic Nephropathy on Human IgG Pharmacokinetics in Rats

Gurkishan S. Chadha,Marilyn E. Morris

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 2.63 MB

english, 2015

15

Visual Predictive Check in Models with Time-Varying Input Function

A. Largajolli, A. Bertoldo, M. Campioni, C. Cobelli

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 857 KB

english, 2015

16

Region-Dependent Role of Cell-Penetrating Peptides in Insulin Absorption Across the Rat Small Intestinal Membrane

Khafagy, El-Sayed, Iwamae, Ruisha, Kamei, Noriyasu, Takeda-Morishita, Mariko

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 887 KB

english, 2015

17

Erratum to: Is Extrapolation of the Safety and Efficacy Data in One Indication to Another Appropriate for Biosimilars?

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 66 KB

english, 2015

18

Measurement of FreeVersusTotal Therapeutic Monoclonal Antibody in Pharmacokinetic Assessment is Modulated by Affinity, Incubation Time, and Bioanalytical Platform

Talbot, Jeffrey J., Calamba, Dominador, Pai, Melody, Ma, Mark, Thway, Theingi M.

Journal:

The AAPS Journal

Year:

2015

File:

PDF, 1.15 MB

2015

19

De-agglomeration Effect of the US Pharmacopeia and Alberta Throats on Carrier-Based Powders in Commercial Inhalation Products

Leung, Sharon Shui Yee, Tang, Patricia, Zhou, Qi, Tong, Zhenbo, Leung, Cassandra, Decharaksa, Janwit, Yang, Runyu, Chan, Hak-Kim

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 788 KB

english, 2015

20

Erratum to: Clinical Immunogenicity of rHuPH20, a Hyaluronidase Enabling Subcutaneous Drug Administration

Rosengren, Sanna, Dychter, Samuel S., Printz, Marie A., Huang, Lei, Schiff, Richard I., Schwarz, Hans-Peter, McVey, John K., Drake, Fred H., Maneval, Dan C., Kennard, Don A., Frost, Gregory I., Sugarm

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 68 KB

english, 2015

21

Measurement of FreeVersusTotal Therapeutic Monoclonal Antibody in Pharmacokinetic Assessment is Modulated by Affinity, Incubation Time, and Bioanalytical Platform

Talbot, Jeffrey J., Calamba, Dominador, Pai, Melody, Ma, Mark, Thway, Theingi M.

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 1.15 MB

english, 2015

22

High Sensitivity RT-qPCR Assay of Nonlabeled siRNA in Small Blood Volume for Pharmacokinetic Studies: Application to Survivin siRNA

Yeung, Bertrand Z., Lu, Ze, Wientjes, Guillaume M., Au, Jessie L.-S.

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 734 KB

english, 2015

23

Examination of Gossypol-Pluronic Micelles as Potential Radiosensitizers

Tomoda, Keishiro, Chiang, Carol, Kozak, Kevin R., Kwon, Glen S.

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 424 KB

english, 2015

24

Marketplace Analysis of Conjugated Estrogens: Determining the Consistently Present Steroidal Content with LC-MS

Levy, Michaella J., Boyne, Michael T., Rogstad, Sarah, Skanchy, David J., Jiang, Xiaohui, Geerlof-Vidavsky, Ilan

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 707 KB

english, 2015

25

Evaluation of Approaches to Deal with Low-Frequency Nuisance Covariates in Population Pharmacokinetic Analyses

Lagishetty, Chakradhar V., Duffull, Stephen B.

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 481 KB

english, 2015

26

Erratum to: Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Chang, Rong-Kun, Raw, Andre, Lionberger, Robert, Yu, Lawrence

Journal:

The AAPS Journal

Year:

2015

Language:

english

File:

PDF, 82 KB

english, 2015