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Archive of "The AAPS Journal".

ISSN Print: 1550-7416

ISSN Online:

Website: https://www.ncbi.nlm.nih.gov/pmc/journals/792/

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Novel Nanostructured Solid Materials for Modulating Oral Drug Delivery from Solid-State Lipid-Based Drug Delivery Systems

Clive A. Prestidge,Nicky Thomas,Shasha Rao,Tahnee J. Dening

The Effect of Digestion and Drug Load on Halofantrine Absorption from Self-nanoemulsifying Drug Delivery System (SNEDDS)

Anette Müllertz,Kishor M. Wasan,Maria H？toft Michaelsen,Olena Sivak,Thomas Rades

Reduction of a Whole-Body Physiologically Based Pharmacokinetic Model to Stabilise the Bayesian Analysis of Clinical Data

Etienne Pigeolet,Kayode Ogungbenro,Leon Aarons,Nikolaos Tsamandouras,Swati Dumitras,Thierry Wendling

Macromolecular Modelling and Docking Simulations for the Discovery of Selective GPER Ligands

Adele Vivacqua,Assunta Pisano,Camillo Rosano,Lamberto Felli,Marco Ponassi,Maria Francesca Santolla,Rosamaria Lappano

Pharmacokinetics of Morphine and Its Metabolites in Infants and Young Children After Congenital Heart Surgery

Adam Frymoyer,David R. Drover,Felice Su,Gregory B. Hammer,Jeffery L. Galinkin,Kristi L. Glotzbach,Mohammed H. Elkomy

BDDCS Predictions, Self-Correcting Aspects of BDDCS Assignments, BDDCS Assignment Corrections, and Classification for more than 175 Additional Drugs

Chelsea M. Hosey,Leslie Z. Benet,Rosa Chan

Pharma Success in Product Development—Does Biotechnology Change the Paradigm in Product Development and Attrition

Ronald P. Evens

Effects of Surface Composition on the Aerosolisation and Dissolution of Inhaled Antibiotic Combination Powders Consisting of Colistin and Rifampicin

Jian Li,John A. Denman,Mingshi Yang,Nicolas Barraud,Qi Tony Zhou,Scott A. Rice,Si-Ping Sun,Thomas R. Gengenbach,Wenbo Wang

Deconvolution and IVIVC: Exploring the Role of Rate-Limiting Conditions

Adam S. Darwich,Aleksandra Galetin,Alison Margolskee,Amin Rostami-Hodjegan,Leon Aarons

Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

Adam C. Fisher,Anna Schwendeman,Arzu Selen,Ashley Boam,Barbara Allen,Bernhardt L. Trout,Brian Hasselbalch,Bruce D. Johnson,David Doleski,Diane Zezza,Emanuela Lacana,Fionnuala Walsh,G. K. Raju,Ganapathy Mohan,Geoffrey Wu,Giuseppe Randazzo,Grace McNally,Gregory Amidon,Henry Havel,Ilgaz Akseli,Janet Woodcock,Jim Polli,Joseph Famulare,Katherine Tyner,Larisa Wu,Lawrence X. Yu,Louis Yu,Mahesh Ramanadham,Margaret Caulk,Martin VanTrieste,Mary Oates,Mehul Mehta,Michael P. Thien,Moheb Nasr,Paul Seo,Paula Katz,Ramesh Sood,Richard Lostritto,Robert Iser,Robert Ju,Roger Nosal,Russell Wesdyk,Sau L. Lee,Scott Furness,Siva Vaithiyalingam,Stephen W. Hoag,Susan Rosencrance,Tara Gooen Bizjak,Thomas O’Connor,Tony Tong,Vinod Shah

Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

Hae Young Ahn,Jie Wang,Lanyan Fang,Lin Zhou,Yow-Ming C. Wang,Yuen Yi Hon

In Vitro and In Vivo Human Metabolism of Synthetic Cannabinoids FDU-PB-22 and FUB-PB-22

Ariane Wohlfarth,Karl B. Scheidweiler,Marilyn A. Huestis,Robert Kronstrand,Shaokun Pang,Xingxing Diao

Regulator of G Protein Signaling 17 as a Negative Modulator of GPCR Signaling in Multiple Human Cancers

David L. Roman,Michael P. Hayes

Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications

Angelica Dorantes,Anna Externbrink,John Duan,Paul Seo,Poonam R. Delvadia,Sandra Suarez-Sharp,Sarah Pope Miksinski,Tapash Ghosh,Zongming Gao

Recent Advances in Application of Pharmacogenomics for Biotherapeutics

Pramod B. Mahajan

Determination of Cellular Processing Rates for a Trastuzumab-Maytansinoid Antibody-Drug Conjugate (ADC) Highlights Key Parameters for ADC Design

Alison M. Betts,Chethana Kulkarni,K. Dane Wittrup,Katie F. Maass

Aggregation Kinetics for IgG1-Based Monoclonal Antibody Therapeutics

A. Singla,Anurag S. Rathore,R. Bansal,Varsha Joshi

Pharmacodynamic Model of Hepcidin Regulation of Iron Homeostasis in Cynomolgus Monkeys

Barbra Sasu,Beth Hinkle,Jim J. Xiao,Juan Jose Perez-Ruixo,Wojciech Krzyzanski

Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage Forms

Deliang Zhou,Stephen Hoag,Yihong Qiu,Zhongqiang Lin

R4 Regulator of G Protein Signaling (RGS) Proteins in Inflammation and Immunity

Eunice C. Chan,Kirk M. Druey,Zhihui Xie

Ligand-Binding Assay Development: What Do You Want to Measure Versus What You Are Measuring?

Andrew P. Mayer,Charles S. Hottenstein

Influence of Copolymer Composition on In Vitro and In Vivo Performance of Celecoxib-PVP/VA Amorphous Solid Dispersions

Huiling Mu,Julia Hoang Nguyen,Matthias Manne Knopp,Peter Langguth,René Holm,Thomas Rades

Intranasal Delivery of Exendin-4 Confers Neuroprotective Effect Against Cerebral Ischemia in Mice

Di Qu,Huinan Zhang,Jingru Meng,Ling Wang,Ning Wang,Shimeng Zhou,Xiaoxing Luo,Xubo Li,Yunhan Liu

Gut Wall Metabolism. Application of Pre-Clinical Models for the Prediction of Human Drug Absorption and First-Pass Elimination

Amin Rostami-Hodjegan,Anna-Lena Ungell,Christopher R. Jones,Constanze Hilgendorf,Oliver J. D. Hatley,Sheila Annie Peters

Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling

Joseph A. Grillo,Robert N. Schuck

Erratum to: Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations?

Connie S. Langer,Dorys Argelia Diaz,Leslie Van Alstine,Michael D. Likar,Nagesh Bandi,Stephen T. Colgan

Development of a Physiologically Based Pharmacokinetic Model to Predict Disease-Mediated Therapeutic Protein–Drug Interactions: Modulation of Multiple Cytochrome P450 Enzymes by Interleukin-6

Honghui Zhou,Weirong Wang,Xiling Jiang,Yanli Zhuang,Zhenhua Xu

Analytical Similarity Assessment in Biosimilar Studies

Fuyu Song,He Bai,Shein-Chung Chow

Does the Systemic Plasma Profile Inform the Liver Profile? Analysis Using a Physiologically Based Pharmacokinetic Model and Individual Compounds

Hugh A. Barton,Kevin Sweeney,Rui Li,Tristan S. Maurer

Gomisin A is a Novel Isoform-Specific Probe for the Selective Sensing of Human Cytochrome P450 3A4 in Liver Microsomes and Living Cells

Guang-Bo Ge,Jing Ning,Jing-Jing Wu,Liang-Hai Hu,Ling Yang,Ping Wang,Yu-Qi He,Zi-Ru Dai

Approaches to the Development of Human Health Toxicity Values for Active Pharmaceutical Ingredients in the Environment

Tamara L. Sorell

Pharmacokinetic Interactions for Drugs with a Long Half-Life—Evidence for the Need of Model-Based Analysis

Bj？rn Clauson,Chayan Acharya,Elin M. Svensson,Kelly E. Dooley,Mats O. Karlsson

Modeling Testosterone Circadian Rhythm in Hypogonadal Males: Effect of Age and Circannual Variations

Fahima Nekka,Julie Desrochers,Mario González-Sales,Mario Tanguay,Olivier Barrière,Pierre-Olivier Tremblay

Novel Injectable Pentablock Copolymer Based Thermoresponsive Hydrogels for Sustained Release Vaccines

Arlene McDowell,Ashim K. Mitra,Sarah Hook,Sharan Bobbala,Viral Tamboli

Pre-existing Antibody: Biotherapeutic Modality-Based Review

Adrienne Clements-Egan,Boris Gorovits,Crystal Sung,Heather Myler,Kun Peng,Laura Salazar-Fontana,Li Xue,Manoj Rajadhyaksha,Mary Birchler,Meina Liang,Shobha Purushothama

Pediatric Biopharmaceutical Classification System: Using Age-Appropriate Initial Gastric Volume

Ramzi Shawahna

Preclinical Pharmacokinetics Study of R- and S-Enantiomers of the Histone Deacetylase Inhibitor, AR-42 (NSC 731438), in Rodents

Ching-Shih Chen,Christopher C. Coss,Dasheng Wang,Guido Marcucci,Jiang Wang,Joseph M. Covey,Kenneth K. Chan,Mitch A. Phelps,Ramiro Garzon,Samuel K. Kulp,William P. Jones,Xiaohui Tracey Wei,Zhiliang Xie,Zhongfa Liu

Reserpine Inhibit the JB6 P+ Cell Transformation Through Epigenetic Reactivation of Nrf2-Mediated Anti-oxidative Stress Pathway

Ah-Ng Tony Kong,Bo Hong,Chengyue Zhang,Wenjing Li,Yue Guo,Yuqing Yang,Zhengyuan Su

RGS6 as a Novel Therapeutic Target in CNS Diseases and Cancer

Bandana Chakravarti,Katelin E. Ahlers,Rory A. Fisher

Evaluating In Vivo-In Vitro Correlation Using a Bayesian Approach

Junshan Qiu,Marilyn Martinez,Ram Tiwari

A Whole-Body Physiologically Based Pharmacokinetic Model of Gefitinib in Mice and Scale-Up to Humans

Daryl J. Murry,Guohua An,Jiexin Deng,Youwei Bi

A Mass Balance-Based Semiparametric Approach to Evaluate Neonatal Erythropoiesis

Demet Nalbant,Denison J. Kuruvilla,Donald M. Mock,John A. Widness,Peter Veng-Pedersen,Robert L. Schmidt

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

Andreas Jeromin,Bill Nowatzke,Carol Gleason,Darshana Jani,Flora Berisha,John Allinson,Kyra J. Cowan,Laurie Stephen,Masood U. Khan,Paul Rhyne,Steve Keller,Viswanath Devanarayan

Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies

Akshanth R. Polepally,Amit Khatri,Denise K？nig,Rajeev M. Menon,Sandeep Dutta,Sven Mensing,Thomas J. Podsadecki,Walid M. Awni,Wei Liu

Pattern Recognition in Pharmacokinetic Data Analysis

Bernd Meibohm,Daniel Weiner

Thermosensitive Hydrogel Co-loaded with Gold Nanoparticles and Doxorubicin for Effective Chemoradiotherapy

Cai Zhang,Jianzhen Wang,Mingfu Zhang,Na Zhang,Tianqi Wang,Tingting Li,Xiaomei Zhang,Yao Yao

An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence

Laszlo Endrenyi,Laszlo Tothfalusi

Prediction of Human Glomerular Filtration Rate from Preterm Neonates to Adults: Evaluation of Predictive Performance of Several Empirical Models

Carl-Michael Staschen,Iftekhar Mahmood

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

An Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs

Eric Woolf,Julie Stone,Lisa A. Shipley,Marissa Dockendorf,Prajakti A. Kothare,Yang Xu

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