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FDA’s Poly (Lactic-Co-Glycolic Acid) Research Program and Regulatory Outcomes Yan WangBin QinStephanie H. Choi Review Article 29 June 2021 Article: 92
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Employing Drug Delivery Strategies to Overcome Challenges Using TLR7/8 Agonists for Cancer Immunotherapy Dhruv VarshneySherry Yue QiuKevin J. McHugh Review Article 28 June 2021 Article: 90
PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus Ke Xu SzetoMaxime Le MerdyViera Lukacova Research Article Open access 24 June 2021 Article: 89
Formoterol PLGA-PEG Nanoparticles Induce Mitochondrial Biogenesis in Renal Proximal Tubules Ernest L. VallorzKaren Blohm-MangoneHeidi M. Mansour Research Article 24 June 2021 Article: 88
Recent Advances in 3D Printing for Parenteral Applications Ryan IvoneYan YangJie Shen Review Article 18 June 2021 Article: 87
Population Model of Serum Creatinine as Time-Dependent Covariate in Neonates Wojciech KrzyzanskiAnne SmitsKarel Allegaert Research Article 17 June 2021 Article: 86
Use of Physiologically Based Pharmacokinetic Modeling for Predicting Drug–Food Interactions: Recommendations for Improving Predictive Performance of Low Confidence Food Effect Models Christian WagnerFilippos KesisoglouArian Emami Riedmaier Research Article 17 June 2021 Article: 85
Evaluation of Microparticulate (S)-4,5-Dihydroxy-2,3-pentanedione (DPD) as a Potential Vaccine Adjuvant Devyani JoshiChristiane ChbibMartin J. D’Souza Research Article 15 June 2021 Article: 84
Correction to: Incorporating Breastfeeding-Related Variability with Physiologically Based Pharmacokinetic Modeling to Predict Infant Exposure to Maternal Medication Through Breast Milk: a Workflow Applied to Lamotrigine Cindy H. T. YeungShinya ItoAndrea N. Edginton Correction 10 June 2021 Article: 83
Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies) Oliver AckaertDavid McDougallHerta M. Crauwels Research Article 07 June 2021 Article: 82
Translational CNS Steady-State Drug Disposition Model in Rats, Monkeys, and Humans for Quantitative Prediction of Brain-to-Plasma and Cerebrospinal Fluid-to-Plasma Unbound Concentration Ratios Sho SatoKota MatsumiyaYohei Kosugi Research Article Open access 03 June 2021 Article: 81
Therapeutic Genome Editing and In Vivo Delivery Amanda Catalina Ramirez-PhillipsDexi Liu Review Article 02 June 2021 Article: 80
Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial Carolina Llanos-PaezClaire AmberyMats O. Karlsson Research Article Open access 02 June 2021 Article: 79
Non-viral Vectors in Gene Therapy: Recent Development, Challenges, and Prospects Hui ZuDanchen Gao Review Article 02 June 2021 Article: 78
Systems Modeling to Quantify Safety Risks in Early Drug Development: Using Bifurcation Analysis and Agent-Based Modeling as Examples Carmen PinTeresa CollinsHolly Kimko Mini-Review Open access 20 May 2021 Article: 77
Modulating Oral Delivery and Gastrointestinal Kinetics of Recombinant Proteins via Engineered Fungi Mairead K. HeaveyAaron C. Anselmo Research Article 19 May 2021 Article: 76
Developing Tools to Evaluate Non-linear Mixed Effect Models: 20 Years on the npde Adventure Emmanuelle CometsFrance Mentré Review Article 19 May 2021 Article: 75
Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities Nadia TerranovaKarthik VenkatakrishnanLisa J. Benincosa Commentary Open access 18 May 2021 Article: 74
A Systematic Approach in the Development of the Morphologically-Directed Raman Spectroscopy Methodology for Characterizing Nasal Suspension Drug Products Gonçalo FariasJagdeep ShurBryan Newman Research Article Open access 18 May 2021 Article: 73
Direct Comparison of the Prediction of the Unbound Brain-to-Plasma Partitioning Utilizing Machine Learning Approach and Mechanistic Neuropharmacokinetic Model Yohei KosugiKunihiko MizunoMichael Zientek Research Article Open access 18 May 2021 Article: 72
Towards Evidence-Based Weaning: a Mechanism-Based Pharmacometric Model to Characterize Iatrogenic Withdrawal Syndrome in Critically Ill Children Sebastiaan C. GouloozeErwin IstaCatherijne A. J. Knibbe Research Article Open access 17 May 2021 Article: 71
Incorporating Breastfeeding-Related Variability with Physiologically Based Pharmacokinetic Modeling to Predict Infant Exposure to Maternal Medication Through Breast Milk: a Workflow Applied to Lamotrigine Cindy H. T. YeungShinya ItoAndrea N. Edginton Research Article 17 May 2021 Article: 70
Amorphous Solid Dispersions Containing Residual Crystallinity: Competition Between Dissolution and Matrix Crystallization Dana E. MosesonIsaac D. CorumLynne S. Taylor Research Article 17 May 2021 Article: 69