Strategies to Determine Assay Format for the Assessment of Neutralizing Antibody Responses to Biotherapeutics Bonnie WuShan ChungShalini Gupta White Paper 05 August 2016 Pages: 1335 - 1350
Where Are the Nanodrugs? An Industry Perspective on Development of Drug Products Containing Nanomaterials Henry A. Havel Commentary 12 August 2016 Pages: 1351 - 1353
A Quality by Design Approach to Developing and Manufacturing Polymeric Nanoparticle Drug Products Greg TroianoJim NolanStephen Zale Commentary 08 September 2016 Pages: 1354 - 1365
Workshop Report: Crystal City VI—Bioanalytical Method Validation for Biomarkers Mark E. ArnoldBrian BoothChad Ray Meeting Report 11 August 2016 Pages: 1366 - 1372
Nanomedicines: From Bench to Bedside and Beyond Henry HavelGregory FinchMaggie Liu Review Article 01 August 2016 Pages: 1373 - 1378
Regulatory Experience with In Vivo In Vitro Correlations (IVIVC) in New Drug Applications Sandra Suarez-SharpMin LiPaul Seo Review Article 01 August 2016 Pages: 1379 - 1390
Challenges and Opportunities with Non-CYP Enzymes Aldehyde Oxidase, Carboxylesterase, and UDP-Glucuronosyltransferase: Focus on Reaction Phenotyping and Prediction of Human Clearance Upendra A. ArgikarPhilip M. PotterPunit H. Marathe Review Article 05 August 2016 Pages: 1391 - 1405
Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development Min LiSanna SanderBhagwant Rege Review Article 20 September 2016 Pages: 1406 - 1417
Best Practices in Stability Indicating Method Development and Validation for Non-clinical Dose Formulations Teresa R. HenryLara D. PennBrian W. Pack Review Article 06 September 2016 Pages: 1418 - 1423
Physiologically Based Absorption Modeling to Design Extended-Release Clinical Products for an Ester Prodrug Xuan DingJeffrey S. DayDavid C. Sperry Research Article 12 July 2016 Pages: 1424 - 1438
Evaluating Immunogenicity Risk Due to Host Cell Protein Impurities in Antibody-Based Biotherapeutics Vibha JawaMarisa K. JoubertGregory C. Flynn Research Article 22 July 2016 Pages: 1439 - 1452
A Physiologically Based Pharmacokinetic Model for Ganciclovir and Its Prodrug Valganciclovir in Adults and Children V. LukacovaP. GoelzerN. Parrott Research Article 22 July 2016 Pages: 1453 - 1463
Physiologically Based Absorption Modeling to Explore the Impact of Food and Gastric pH Changes on the Pharmacokinetics of Alectinib Neil J ParrottLi J YuPeter N. Morcos Research Article 22 July 2016 Pages: 1464 - 1474
An Agent-Based Approach to Dynamically Represent the Pharmacokinetic Properties of Baicalein Xiao ZhuJianyuan DengTai Ning Lam Research Article 01 August 2016 Pages: 1475 - 1488
Metabolism of Carfentanil, an Ultra-Potent Opioid, in Human Liver Microsomes and Human Hepatocytes by High-Resolution Mass Spectrometry Michael G. FeaselAriane WohlfarthMarilyn A. Huestis Research Article 05 August 2016 Pages: 1489 - 1499
Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses Edwin Chiu Yuen ChowArjang TalattofXinyuan Zhang Research Article 12 August 2016 Pages: 1500 - 1511
Utilizing In Vitro Dissolution-Permeation Chamber for the Quantitative Prediction of pH-Dependent Drug-Drug Interactions with Acid-Reducing Agents: a Comparison with Physiologically Based Pharmacokinetic Modeling Andy Z. X. ZhuMing-Chih David HoCindy Q. Xia Research Article 06 September 2016 Pages: 1512 - 1523
P-glycoprotein Function in the Rodent Brain Displays a Daily Rhythm, a Quantitative In Vivo PET Study Heli SavolainenPeter MeerloGert Luurtsema Research Article Open access 06 September 2016 Pages: 1524 - 1531
Development of a Novel Simplified PBPK Absorption Model to Explain the Higher Relative Bioavailability of the OROS® Formulation of Oxybutynin Andrés Olivares-MoralesAvijit GhoshAmin Rostami-Hodjegan Research Article Open access 08 September 2016 Pages: 1532 - 1549
Assessment of the Regulatory Methods for the Comparison of Highly Variable Dissolution Profiles Victor Mangas-SanjuanSarin Colon-UsecheAlfredo Garcia-Arieta Research Article 29 August 2016 Pages: 1550 - 1561
The Dual Role of Lipids of the Lipoproteins in Trumenba, a Self-Adjuvanting Vaccine Against Meningococcal Meningitis B Disease Yin LuoOlga V. FrieseJason C. Rouse Research Article Open access 07 September 2016 Pages: 1562 - 1575
Nanomedicines in the EU—Regulatory Overview Ruben PitaFalk EhmannMarisa Papaluca Regulatory Note 15 August 2016 Pages: 1576 - 1582
Erratum to: Does the Recent Growth of Aquaculture Create Antibiotic Resistance Threats Different from those Associated with Land Animal Production in Agriculture? Hansa Y. DoneArjun K. VenkatesanRolf U. Halden Erratum 21 April 2016 Pages: 1583 - 1583
Erratum to: Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin Marilyn MartinezBipin MistryRaafat Fahmy Erratum 23 May 2016 Pages: 1584 - 1584
Erratum to: Computational Advances for the Development of Allosteric Modulators and Bitopic Ligands in G Protein-Coupled Receptors Zhiwei FengGuanxing HuXiang-Qun Xie Erratum 21 October 2016 Pages: 1585 - 1585