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Impact of Dapagliflozin on Hepatic Lipid Metabolism and a Dynamic Model of Ketone Body Levels
Impact of Dapagliflozin on Hepatic Lipid Metabolism and a Dynamic Model of Ketone Body Levels
The rising prevalence of metabolic-associated steatotic liver disease emphasizes the need to understand its lipid metaboli...
Pharmaceutical Sciences: Insights and Observations from Academic Chairs and Vice Chairs
Pharmaceutical Sciences: Insights and Observations from Academic Chairs and Vice Chairs
On October 29, 2024, a virtual meeting, brought together chairs and vice chairs from several research-oriented U.S. School...
Prediction of Area Under the Curve from Urinary Vancomycin Concentrations Measured Using a Simple Method
Prediction of Area Under the Curve from Urinary Vancomycin Concentrations Measured Using a Simple Method
Therapeutic drug monitoring (TDM) is recommended during vancomycin (VCM) administration to adjust the dosage such that the...
Development of a PBPK Model for Lamotrigine which Incorporates Metabolism by UGT2B10: Impact of UGT2B10 Poor Metabolizer Phenotype and Pregnancy
Development of a PBPK Model for Lamotrigine which Incorporates Metabolism by UGT2B10: Impact of UGT2B10 Poor Metabolizer Phenotype and Pregnancy
An updated physiologically based pharmacokinetic (PBPK) model was developed for lamotrigine by incorporating a component o...
Correction: Assessing Immunogenicity in Drug Reviews and Prescribing Information in Japan
Correction: Assessing Immunogenicity in Drug Reviews and Prescribing Information in Japan
Cite this articleIshibai, M., Kai, M., Wakuda, H. et al. Correction: Assessing Immunogenicity in Drug Reviews and Prescrib...
Analysis on the Impact of U.S. FDA’s Narrow Therapeutic Index Bioequivalence Criteria on Generic Drug Applications
Analysis on the Impact of U.S. FDA’s Narrow Therapeutic Index Bioequivalence Criteria on Generic Drug Applications
Since 2012, the U.S. Food and Drug Administration (FDA) has developed classification criteria of narrow therapeutic index ...
Stability of Anti-Drug Antibodies Against Antibody Therapeutics
Stability of Anti-Drug Antibodies Against Antibody Therapeutics
Biotherapeutics have the potential to elicit unwanted immune responses that can lead to the production of anti-drug antibo...
Addressing Clinical Challenges in Aberrant Pharmacokinetics of Biologic Therapeutic Drugs: Investigating Sample Processing Procedure in the Immunoassays
Addressing Clinical Challenges in Aberrant Pharmacokinetics of Biologic Therapeutic Drugs: Investigating Sample Processing Procedure in the Immunoassays
Bioanalytical Pharmacokinetics (PK) methods are designed for robust performance under rigorous regulatory compliance requi...
Bioequivalence of ANDA Data using a Non-Informative Bayesian Procedure (BEST) Compared with the Two One‑Sided t‑Tests (TOST)
Bioequivalence of ANDA Data using a Non-Informative Bayesian Procedure (BEST) Compared with the Two One‑Sided t‑Tests (TOST)
The regulatory statistical standard for evaluating average bioequivalence (BE) in generic drug testing, formulation bridgi...
Unraveling Ceftriaxone Dosing: Free Drug Prediction, Threshold Optimization, and Model Validation
Unraveling Ceftriaxone Dosing: Free Drug Prediction, Threshold Optimization, and Model Validation
Ceftriaxone is pivotal in treating severe infections; however, predicting unbound plasma ceftriaxone (CEFu) from total cef...
Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper
Blend Uniformity and Content Uniformity in Oral Solid Dosage Manufacturing: an IQ Consortium Industry Position Paper
The IQ Consortium Uniformity Testing Working Group reviewed the current BU and CU testing practices among ten member compa...
Considerations in K-based Strategy for Selecting CNS-targeted Drug Candidates with Sufficient Target Coverage and Substantial Pharmacodynamic Effect
Considerations in K-based Strategy for Selecting CNS-targeted Drug Candidates with Sufficient Target Coverage and Substantial Pharmacodynamic Effect
Kp,uu,brain is a critical parameter for evaluating the brain penetration of CNS-targeted compounds, reflecting the ratio o...
Models to Elucidate Mechanisms of Bile Acid Disposition and Cellular Aerobics in Human Hepatocytes
Models to Elucidate Mechanisms of Bile Acid Disposition and Cellular Aerobics in Human Hepatocytes
Understanding the kinetics of hepatic processes, such as bile acid (BA) handling and cellular aerobic metabolism, is cruci...
From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-Validation
From Guidelines to Implementation: A Case Study on Applying ICH M10 for Bioanalytical Assay Cross-Validation
Bioanalytical cross-validation plays a crucial role in ensuring data exchangeability throughout the assay life cycle for d...
A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities
A Phase-Appropriate Risk Assessment Strategy in Support of the Safety of Peptide and Oligonucleotide-Related Impurities
There is limited regulatory guidance that outlines the globally acceptable level of individual and total impurities presen...
A Population Model of Time-Dependent Changes in Serum Creatinine in (Near)term Neonates with Hypoxic-Ischemic Encephalopathy During and After Therapeutic Hypothermia
A Population Model of Time-Dependent Changes in Serum Creatinine in (Near)term Neonates with Hypoxic-Ischemic Encephalopathy During and After Therapeutic Hypothermia
The objective was to apply a population model to describe the time course and variability of serum creatinine (sCr) in (ne...
Therapeutic Fusion Proteins
Therapeutic Fusion Proteins
Therapeutic fusion proteins are a class of hybrid constructs that combine distinct biomolecules into a single platform wit...
Correction: A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications
Correction: A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, whi...
Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development
Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development
Volumetric absorptive microsampling (VAMS) techniques have gained popularity these last years as innovative tool for colle...
The AAPS Journal Theme Issue: “Perspectives on Clinical Drug Development of Long-Acting Injectables”
The AAPS Journal Theme Issue: “Perspectives on Clinical Drug Development of Long-Acting Injectables”
The development of long-acting injectable (LAI) drugs has gained increased intere...
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors
The prediction of transgene product expression in human is important to guide first-in-human (FIH) dose selection for vira...
A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications
A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications
A crucial step in lead selection during drug development is accurate estimation and optimization of hepatic clearance usin...
Tuning the Emulsion Properties Influences the Size of Poly(Caprolactone) Particles for Drug Delivery Applications
Tuning the Emulsion Properties Influences the Size of Poly(Caprolactone) Particles for Drug Delivery Applications
Advances in drug delivery have been accelerated with the addition of polymeric drug carriers. Direct delivery to a target ...
Drug Dissolution in Oral Drug Absorption: Workshop Report
Drug Dissolution in Oral Drug Absorption: Workshop Report
The in-person workshop “Drug Dissolution in Oral Drug Absorption” was held on May 23–24, 2023, in Baltim...
Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development
Role of Modeling and Simulation in Preclinical and Clinical Long-Acting Injectable Drug Development
Innovations in the field of long-acting injectable drug development are increasingly being reported. More advanced in vitr...
Quantitative Translation of Substrate Intrinsic Clearance from Recombinant CYP1A1 to Humans
Quantitative Translation of Substrate Intrinsic Clearance from Recombinant CYP1A1 to Humans
CYP1A1 is a cytochrome P450 family 1 enzyme that is mostly expressed in the extrahepatic tissues. To understand the CYP1A1...
Single Particle Chemical Characterisation of Nanoformulations for Cargo Delivery
Single Particle Chemical Characterisation of Nanoformulations for Cargo Delivery
Nanoparticles can encapsulate a range of therapeutics, from small molecule drugs to sensitive biologics, to significantly ...
Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary
Applications of Modeling and Simulation Approaches in Support of Drug Product Development of Oral Dosage Forms and Locally Acting Drug Products: a Symposium Summary
The number of modeling and simulation applications, including physiologically based pharmacokinetic (PBPK) models, physiol...
An Antibody-Dependent Cellular Cytotoxicity Assay for Detecting Ocrelizumab Neutralizing Antibody
An Antibody-Dependent Cellular Cytotoxicity Assay for Detecting Ocrelizumab Neutralizing Antibody
Ocrelizumab (OCREVUS®) is a humanized anti-CD20 monoclonal antibody approved for the treatment of adult patients with...
RNA Nanomedicine: Delivery Strategies and Applications
RNA Nanomedicine: Delivery Strategies and Applications
Delivery of RNA using nanomaterials has emerged as a new modality to expand therapeutic applications in biomedical researc...
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