SCI时时刷

search
+
Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution
Biodistribution of Drug/ADA Complexes: The Impact of Immune Complex Formation on Antibody Distribution
The clinical use of therapeutic monoclonal antibodies (mAbs) for the treatment of cancer, inflammation, and other indicati...
Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes
Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes
ICH Q12 asserts that science- and risk-based approaches are applicable to stability studies supporting Chemistry, Manufact...
State of the Art of Silica Nanoparticles: An Overview on Biodistribution and Preclinical Toxicity Studies
State of the Art of Silica Nanoparticles: An Overview on Biodistribution and Preclinical Toxicity Studies
Over the past few years, nanoparticles have drawn particular attention in designing and developing drug delivery systems d...
Novel Multiplexed High Throughput Screening of Selective Inhibitors for Drug-Metabolizing Enzymes Using Human Hepatocytes
Novel Multiplexed High Throughput Screening of Selective Inhibitors for Drug-Metabolizing Enzymes Using Human Hepatocytes
Selective chemical inhibitors are critical for reaction phenotyping to identify drug-metabolizing enzymes that are involve...
Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate
Development and Validation of a Cell-Based Binding Neutralizing Antibody Assay for an Antibody–Drug Conjugate
The utilization of antibody–drug conjugates (ADCs) has gained considerable attention in the field of targeted cancer...
Characterization and Applications of Permeabilized Hepatocytes in Drug Discovery
Characterization and Applications of Permeabilized Hepatocytes in Drug Discovery
Hepatocytes are one of the most physiologically relevant in vitro liver systems for human translation of clearance and dru...
PmWebSpec: An Application to Create and Manage CDISC-Compliant Pharmacometric Analysis Dataset Specifications
PmWebSpec: An Application to Create and Manage CDISC-Compliant Pharmacometric Analysis Dataset Specifications
A well-documented pharmacometric (PMx) analysis dataset specification ensures consistency in derivations of the variables,...
Predicting the Stability of Lyophilized Human Serum Albumin Formulations Containing Sucrose and Trehalose Using Solid-State NMR Spectroscopy: Effect of Storage Temperature on 1H T1 Relaxation Times
Predicting the Stability of Lyophilized Human Serum Albumin Formulations Containing Sucrose and Trehalose Using Solid-State NMR Spectroscopy: Effect of Storage Temperature on 1H T1 Relaxation Times
In a lyophilized protein/disaccharide system, the ability of the disaccharide to form a homogeneous mixture with the prote...
LC–MS Characterization and Stability Assessment Elucidate Correlation Between Charge Variant Composition and Degradation of Monoclonal Antibody Therapeutics
LC–MS Characterization and Stability Assessment Elucidate Correlation Between Charge Variant Composition and Degradation of Monoclonal Antibody Therapeutics
Aggregation stability of monoclonal antibody (mAb) therapeutics is influenced by many critical quality attributes (CQA) su...
Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety
Cross-Reactive Polyclonal Antibodies Raised Against GalNAc-Conjugated siRNA Recognize Mostly the GalNAc Moiety
Small interfering RNA (siRNA) is gaining momentum as a therapeutic modality with six approved products. Since siRNA has th...
Mechanistic Modeling of In Vitro Biopharmaceutic Data for a Weak Acid Drug: A Pathway Towards Deriving Fundamental Parameters for Physiologically Based Biopharmaceutic Modeling
Mechanistic Modeling of In Vitro Biopharmaceutic Data for a Weak Acid Drug: A Pathway Towards Deriving Fundamental Parameters for Physiologically Based Biopharmaceutic Modeling
Mechanistic modeling of in vitro experiments using metabolic enzyme systems enables the extrapolation of metabolic clearan...
Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing
Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing
Medication administration via enteral feeding tubes (EFT) is a necessary practice for patients unable to swallow oral dosa...
Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop
Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop
The 2023 Generic Drug Science and Research Initiative Public Workshop organized by the U.S. Food and Drug Administration (...
Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine
Bile Acid–Targeted Hyaluronic Acid Nanoparticles for Enhanced Oral Absorption of Deferoxamine
Patients with β-thalassemia and sickle cell disease often rely on blood transfusions which can lead to hemochromatosi...
Preliminary Investigation of a Rapid and Feasible Therapeutic Drug Monitoring Method for the Real-Time Estimation of Blood Pazopanib Concentrations
Preliminary Investigation of a Rapid and Feasible Therapeutic Drug Monitoring Method for the Real-Time Estimation of Blood Pazopanib Concentrations
Pazopanib is a multi-kinase inhibitor used to treat advanced/metastatic renal cell carcinoma and advanced soft tissue tumo...
Ginsenoside Rg1 Alleviates Sepsis-Induced Acute Lung Injury by Reducing FBXO3 Stability in an m6A-Dependent Manner to Activate PGC-1α/Nrf2 Signaling Pathway
Ginsenoside Rg1 Alleviates Sepsis-Induced Acute Lung Injury by Reducing FBXO3 Stability in an m6A-Dependent Manner to Activate PGC-1α/Nrf2 Signaling Pathway
Sepsis-induced acute lung injury (ALI) is one of the serious life-threatening complications of sepsis and is pathologicall...
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...
阅读更多
format_indent_increase