CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products Celia N. CruzKatherine M. TynerElaine Morefield Regulatory Note 20 March 2013 Pages: 623 - 628
Drug–Drug Interaction Studies: Regulatory Guidance and An Industry Perspective Thomayant PrueksaritanontXiaoyan ChuJerome Hochman Commentary 30 March 2013 Pages: 629 - 645
Theoretical Considerations and Practical Approaches to Address the Effect of Anti-drug Antibody (ADA) on Quantification of Biotherapeutics in Circulation Marian KelleyAgo B. AheneJihong Yang Commentary 30 March 2013 Pages: 646 - 658
Sequential Bioequivalence Trial Designs with Increased Power and Controlled Type I Error Rates Anders Fuglsang Brief/Technical Note 30 March 2013 Pages: 659 - 661
Development of a Preclinical PK/PD Model to Assess Antitumor Response of a Sequential Aflibercept and Doxorubicin-Dosing Strategy in Acute Myeloid Leukemia Gerald J. FetterlyUrvi ArasEunice S. Wang Research Article 03 April 2013 Pages: 662 - 673
Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products Rong-Kun ChangAndre RawLawrence Yu Regulatory Note 10 April 2013 Pages: 674 - 683
Nonlinear Absorption Kinetics of Self-Emulsifying Drug Delivery Systems (SEDDS) Containing Tocotrienols as Lipophilic Molecules: In Vivo and In Vitro Studies Saeed AlqahtaniAlaadin AlayoubiAmal Kaddoumi Research Article 10 April 2013 Pages: 684 - 695
Comparative In Silico–In Vivo Evaluation of ASGP-R Ligands for Hepatic Targeting of Curcumin Gantrez Nanoparticles Anisha A. D’SouzaPuneet JainPadma V. Devarajan Research Article 12 April 2013 Pages: 696 - 706
Molecular Mechanisms of Silibinin-Mediated Cancer Chemoprevention with Major Emphasis on Prostate Cancer Harold TingGagan DeepRajesh Agarwal Review Article 16 April 2013 Pages: 707 - 716
Factors Influencing Magnitude and Duration of Target Inhibition Following Antibody Therapy: Implications in Drug Discovery and Development Anjaneya P. ChimalakondaRajbharan YadavPunit Marathe Research Article 16 April 2013 Pages: 717 - 727
Engineered Mannitol Ternary Additives Improve Dispersion of Lactose–Salbutamol Sulphate Dry Powder Inhalations Waseem KaialyAli Nokhodchi Research Article 17 April 2013 Pages: 728 - 743
Resveratrol Suppresses T0901317-Induced Hepatic Fat Accumulation in Mice Mingming GaoDexi Liu Research Article 17 April 2013 Pages: 744 - 752
Protective Effects of Kaempferol on Isoniazid- and Rifampicin-Induced Hepatotoxicity Tung-Yuan ShihTon-Ho YoungOliver Yoa-Pu Hu Research Article 17 April 2013 Pages: 753 - 762
Assessment of Juvenile Pigs to Serve as Human Pediatric Surrogates for Preclinical Formulation Pharmacokinetic Testing Wyatt J. RothCandice B. KissingerGregory T. Knipp Research Article 18 April 2013 Pages: 763 - 774
Risk Assessment of Drug Interaction Potential and Concomitant Dosing Pattern on Targeted Toxicities in Pediatric Cancer Patients Jeffrey S. BarrettDimple PatelJeffrey M. Skolnik Research Article 18 April 2013 Pages: 775 - 786
Clinical Pharmacokinetics of Buffered Propranolol Sublingual Tablet (Promptol™)—Application of a New “Physiologically Based” Model to Assess Absorption and Disposition Yanfeng WangZhijun WangMoses S. S. Chow Research Article 19 April 2013 Pages: 787 - 796
Mathematical Model Approach to Describe Tumour Response in Mice After Vaccine Administration and its Applicability to Immune-Stimulatory Cytokine-Based Strategies Zinnia P. Parra-GuillenPedro BerraondoIñaki F. Troconiz Research Article 19 April 2013 Pages: 797 - 807
What is the Likelihood of an Active Compound to Be Promiscuous? Systematic Assessment of Compound Promiscuity on the Basis of PubChem Confirmatory Bioassay Data Ye HuJürgen Bajorath Research Article 19 April 2013 Pages: 808 - 815
Predictive Models of Diffusive Nanoparticle Transport in 3-Dimensional Tumor Cell Spheroids Yue GaoMingguang LiJessie L.-S. Au Research Article 20 April 2013 Pages: 816 - 831
Effect of Censoring Due to Progressive Disease on Tumor Size Kinetic Parameter Estimates Peter L. BonateBen Suttle Brief Report 20 April 2013 Pages: 832 - 839
Non-Arrhenius Protein Aggregation Wei WangChristopher J. Roberts Review Article 25 April 2013 Pages: 840 - 851
Pre-Existing Biotherapeutic-Reactive Antibodies: Survey Results Within the American Association of Pharmaceutical Scientists Li XueMichele FiscellaAlyssa Morimoto Rapid Communication 26 April 2013 Pages: 852 - 855
Impact of Anti-Drug Antibodies in Preclinical Pharmacokinetic Assessment Theingi M. ThwayIvan MaganaMark Ma Research Article 08 May 2013 Pages: 856 - 863
Epigenetic Modifications of Nrf2 by 3,3′-diindolylmethane In Vitro in TRAMP C1 Cell Line and In Vivo TRAMP Prostate Tumors Tien-Yuan WuTin Oo KhorAh-Ng Tony Kong Research Article 09 May 2013 Pages: 864 - 874
Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic Approval Bing V. LiFeiyan JinDale P. Conner Regulatory Note 18 May 2013 Pages: 875 - 883
Utilization of Gene Expression Signature for Quality Control of Traditional Chinese Medicine Formula Si-Wu-Tang Chen XieZhijun WangZhong Zuo Research Article 24 May 2013 Pages: 884 - 892
Evaluation of Pre-existing Antibody Presence as a Risk Factor for Posttreatment Anti-drug Antibody Induction: Analysis of Human Clinical Study Data for Multiple Biotherapeutics Li XueBonita Rup Rapid Communication 13 June 2013 Pages: 893 - 896