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The Influence of Various Freezing–thawing Methods of Skin on Drug Permeation and Skin Barrier Function
The Influence of Various Freezing–thawing Methods of Skin on Drug Permeation and Skin Barrier Function
The selection of skin is crucial for the in vitro permeation test (IVPT). The purpose of this study was to investigate the...
Self-Sampling by Adolescents at Home: Assessment of the Feasibility to Successfully Collect Blood Microsamples by Inexperienced Individuals
Self-Sampling by Adolescents at Home: Assessment of the Feasibility to Successfully Collect Blood Microsamples by Inexperienced Individuals
Blood microsampling has increasingly attracted interest in the past decades as a more patient-centric sampling approach, o...
Nanosimilars: A Scientific or A Regulatory Debate?
Nanosimilars: A Scientific or A Regulatory Debate?
The paper highlights the necessity for a robust regulatory framework for assessing nanomedicines and their off-patent coun...
Sample Size Determination and Study Design Impact on Dose-Scale Pharmacodynamic Bioequivalence: a Case Study Using Orlistat
Sample Size Determination and Study Design Impact on Dose-Scale Pharmacodynamic Bioequivalence: a Case Study Using Orlistat
Dose-scale pharmacodynamic bioequivalence is recommended for evaluating the consistency of generic and innovator formulati...
Intact NMR Approach Quickly Reveals Synchronized Microstructural Changes in Oil-in-Water Nanoemulsion Formulations
Intact NMR Approach Quickly Reveals Synchronized Microstructural Changes in Oil-in-Water Nanoemulsion Formulations
A soft-core oil-in-water (o/w) nanoemulsion (NE) is composed of nanometer (nm) sized oil droplets, stabilized by a surfact...
Knockout Transporter Cell Lines to Assess Substrate Potential Towards Efflux Transporters
Knockout Transporter Cell Lines to Assess Substrate Potential Towards Efflux Transporters
P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) and multidrug resistance transporter 2 (MRP2) are efflux tr...
Kinetic Modeling for BT200 to Predict the Level of Plasma-Derived Coagulation Factor VIII in Humans
Kinetic Modeling for BT200 to Predict the Level of Plasma-Derived Coagulation Factor VIII in Humans
Lack of Factor VIII (FVIII) concentrates is one of limiting factors for Hemophilia A prophylaxis in resource-limited count...
Neutralizing Antibody Sample Testing and Report Harmonization
Neutralizing Antibody Sample Testing and Report Harmonization
Immunogenicity testing and characterization is an important part of understanding the immune response to administration of...
Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling
Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling
Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-...
Immunogenicity of Atezolizumab: Influence of Testing Method and Sampling Frequency on Reported Anti-drug Antibody Incidence Rates
Immunogenicity of Atezolizumab: Influence of Testing Method and Sampling Frequency on Reported Anti-drug Antibody Incidence Rates
Measurement of anti-drug antibodies (ADA) to assess the incidence of ADA in a clinical trial is a critical step in immunog...
Effect of Physicochemical Properties on the Basic Drug-Acid-Polymer Interactions and Miscibility in PVA Based Orodispersible Films
Effect of Physicochemical Properties on the Basic Drug-Acid-Polymer Interactions and Miscibility in PVA Based Orodispersible Films
Salts of weakly basic drugs can partially dissociate in formulations, to give basic drugs and counter acids. The aim of th...
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022
The effectiveness of the regulatory initiatives, strategies, and incentives put forth in the first two authorizations of t...
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation
Monitoring anti-drug antibodies (ADAs) to infliximab and adalimumab is critical to treatment management in various autoimm...
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices
Western blot (WB) assays are routinely used for detection and quantification of biomarkers. Although assay validation to m...
A Data Driven Strategy and Case Study for Implementation of Singlicate Analysis in Ligand Binding Assays Used for PK Quantitation
A Data Driven Strategy and Case Study for Implementation of Singlicate Analysis in Ligand Binding Assays Used for PK Quantitation
Duplicate analysis has been a conventional practice in the industry for ligand-binding assays (LBA), particularly for plat...
Blood–Brain Barrier Permeability is Affected by Changes in Tight Junction Protein Expression at High-Altitude Hypoxic Conditions—this may have Implications for Brain Drug Transport
Blood–Brain Barrier Permeability is Affected by Changes in Tight Junction Protein Expression at High-Altitude Hypoxic Conditions—this may have Implications for Brain Drug Transport
Changes to blood–brain barrier structure and function may affect the delivery of drugs into the brain. It is worthwh...
An Investigation of In Vitro Anti-Cancer Efficacy of Dihydroartemisinin-Loaded Bovine Milk Exosomes Against Triple-Negative Breast Cancer
An Investigation of In Vitro Anti-Cancer Efficacy of Dihydroartemisinin-Loaded Bovine Milk Exosomes Against Triple-Negative Breast Cancer
Repurposing drugs offers several advantages, including reduced time and cost compared to developing new drugs from scratch...
Predicting Tumor Volume Doubling Time and Progression-Free Survival in Untreated Patients from Patient-Derived-Xenograft (PDX) Models: A Translational Model-Based Approach
Predicting Tumor Volume Doubling Time and Progression-Free Survival in Untreated Patients from Patient-Derived-Xenograft (PDX) Models: A Translational Model-Based Approach
Tumor volume doubling time (TVDT) has been shown to be a potential surrogate marker of biological tumor activity. However,...
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2
The COVID-19 pandemic continues to cause infections and deaths, which are attributable to the SARS-CoV-2 Omicron variant o...
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...
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