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Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules
Affinity Capture Elution Coupled with Cell-based Cyclic Adenosine Monophosphate Assay as a Platform Method for Detection of Neutralizing Antibodies to Incretin Molecules
Formation of anti-drug antibodies (ADA) and, in particular, neutralizing antibodies (NAb), is a major risk to the developm...
Integrated Population Pharmacokinetic-pharmacodynamic Modeling of HIV Virus-host Infection Dynamics in Patients Undergoing Antiretroviral Monotherapy
Integrated Population Pharmacokinetic-pharmacodynamic Modeling of HIV Virus-host Infection Dynamics in Patients Undergoing Antiretroviral Monotherapy
Chronic human immunodeficiency virus (HIV) infection continues to pose a major global health challenge, with an estimated ...
Investigation of 2,4 Di-tert-butylphenol Leaching from Multidose Ophthalmic Devices into Tacrolimus Micellar Formulations
Investigation of 2,4 Di-tert-butylphenol Leaching from Multidose Ophthalmic Devices into Tacrolimus Micellar Formulations
Short contacts between medical devices and medications that they contain can cause drug sorption or leaching of unwanted c...
Clinical Impacts of Immunogenicity in Approved Antibody Drugs in Japan: A Quantitative Evaluation of Pharmacokinetics, Efficacy, and Safety Outcomes
Clinical Impacts of Immunogenicity in Approved Antibody Drugs in Japan: A Quantitative Evaluation of Pharmacokinetics, Efficacy, and Safety Outcomes
Immunogenicity, commonly manifested through the development of anti-drug antibodies (ADAs), is a critical concern for ther...
Net Influx Rather Than Directional Rates: Re-evaluating Transporter Characterization and for Renal and Hepatic Clearance
Net Influx Rather Than Directional Rates: Re-evaluating Transporter Characterization and for Renal and Hepatic Clearance
Here we challenge the assumption that hepatic uptake can be rate-limited solely by transporter-mediated influx clearance, ...
Association of Immunogenicity and Drug Exposure and the Importance of Target Engagement in ADA Development: A Clinical Case Study of Anti-SARS-CoV-2 Biotherapeutics
Association of Immunogenicity and Drug Exposure and the Importance of Target Engagement in ADA Development: A Clinical Case Study of Anti-SARS-CoV-2 Biotherapeutics
The administration of therapeutic proteins, such as monoclonal antibodies (mAbs) may result in the formation of anti-drug ...
Calibration Transfer Across Instrument Vendors for Bioprocess Raman Monitoring
Calibration Transfer Across Instrument Vendors for Bioprocess Raman Monitoring
Raman spectroscopy is a proven Process Analytical Technology (PAT) for monitoring mammalian cell culture processes in biop...
Mechanistic Modeling of Intramuscular Administration of a Long-acting Injectable Accounting for Tissue Response At the Depot Site
Mechanistic Modeling of Intramuscular Administration of a Long-acting Injectable Accounting for Tissue Response At the Depot Site
The tissue response to long-acting injectables (LAIs) suspension injection may impact the product in vivo performance. One...
Matching in Organ Impairment Studies: A Systematic Review of Accepted Methodologies
Matching in Organ Impairment Studies: A Systematic Review of Accepted Methodologies
Although the use of demographic matching in organ impairment studies is recommended to exclude the confounding effect of d...
Dacarbazine-loaded Bilayer Dissolving Microneedle Array Patch for Localized Delivery in Cutaneous Melanoma
Dacarbazine-loaded Bilayer Dissolving Microneedle Array Patch for Localized Delivery in Cutaneous Melanoma
Melanoma is a highly aggressive skin cancer that accounts for only ~ 1% of all skin cancer cases but is respon...
From Liquid SNEDDS to Solid SNEDDS: A Comprehensive Review of Their Development and Pharmaceutical Applications
From Liquid SNEDDS to Solid SNEDDS: A Comprehensive Review of Their Development and Pharmaceutical Applications
The liquid and solid formulations of self-nano-emulsifying drug delivery systems (SNEDDS) have garnered significant attent...
Randomized-Exposure Mixture-Model Analysis (REMIX) allowing Type-1 Error Controlled Exposure–Response Modelling
Randomized-Exposure Mixture-Model Analysis (REMIX) allowing Type-1 Error Controlled Exposure–Response Modelling
In drug development, exposure–response models are widely used to inform decisions in dose optimization processes. Ty...
Establishing the Human Duodenum Chip as a Surrogate for Effective Human Permeability: and Assessment
Establishing the Human Duodenum Chip as a Surrogate for Effective Human Permeability: and Assessment
Drug permeability across epithelial barriers is critical for predicting oral bioavailability and efficacy. Conventional mo...
The Role of Early Exposure Metrics (pAUC and C) in Assessing the Bioequivalence of Methylphenidate Extended-release Products_A Sensitivity Analysis
The Role of Early Exposure Metrics (pAUC and C) in Assessing the Bioequivalence of Methylphenidate Extended-release Products_A Sensitivity Analysis
Methylphenidate extended-release (ER) products are used in the treatment of attention-deficit/hyperactivity disorder (ADHD...
Utilizing Minimal Physiologically Based Pharmacokinetic Modeling to Bridge Bevacizumab Pharmacokinetics from Adult to Pediatric Patients
Utilizing Minimal Physiologically Based Pharmacokinetic Modeling to Bridge Bevacizumab Pharmacokinetics from Adult to Pediatric Patients
Bevacizumab is a humanized monoclonal antibody (mAb) approved to treat various cancers in adults and was investigated in p...
Comparative Evaluation of Approaches to Convert Microsampled Capillary Blood Concentrations to Plasma Concentrations: Paracetamol and Metabolites as a Case Study
Comparative Evaluation of Approaches to Convert Microsampled Capillary Blood Concentrations to Plasma Concentrations: Paracetamol and Metabolites as a Case Study
The past decades have witnessed a growing interest in patient-centric sampling, including dried capillary blood microsampl...
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...
Estimation of Ganciclovir Exposure in Adults Transplant Patients by Machine Learning
Estimation of Ganciclovir Exposure in Adults Transplant Patients by Machine Learning
Valganciclovir, a prodrug of ganciclovir (GCV), is used to prevent cytomegalovirus infection after transplantation, with d...
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...
Cellular Kinetics and Biodistribution of Adoptive T Cell Therapies: from Biological Principles to Effects on Patient Outcomes
Cellular Kinetics and Biodistribution of Adoptive T Cell Therapies: from Biological Principles to Effects on Patient Outcomes
Cell-based immunotherapy has revolutionized cancer treatment in recent years and is rapidly expanding as one of the major ...
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...
Best Practices and Recommendations for Non-Liquid Matrices Bioanalysis
Best Practices and Recommendations for Non-Liquid Matrices Bioanalysis
The analysis of Non-Liquid Matrices (NLMs) can provide key information on many aspects in drug discovery and development. ...
Functional Activity and Binding Specificity of Small Ankyrin Repeat Proteins Called Ankyrons Against SARS-CoV-2 Variants
Functional Activity and Binding Specificity of Small Ankyrin Repeat Proteins Called Ankyrons Against SARS-CoV-2 Variants
Effective management of COVID-19 requires clinical tools to treat the disease in addition to preventive vaccines. Several ...
PBPK Modeling to Recommend Nevirapine Dosing in HIV and HIV-TB Co-infected Patients: Leveraging Enzyme Auto-Induction, Drug Interactions, and Ethnic Variability
PBPK Modeling to Recommend Nevirapine Dosing in HIV and HIV-TB Co-infected Patients: Leveraging Enzyme Auto-Induction, Drug Interactions, and Ethnic Variability
Nevirapine, primarily metabolized by CYP2B6 and CYP3A4, exhibits enzyme auto-induction and significant ethnic variability ...
Uniform Spray Dried Loxapine Microparticles Potentially for Nasal Delivery: Exploring Discriminatory Release Evaluation Methods
Uniform Spray Dried Loxapine Microparticles Potentially for Nasal Delivery: Exploring Discriminatory Release Evaluation Methods
This study aimed to develop suitable in vitro evaluation methods for the release behavior of nasal powders (NPs). We synth...
The Role of Enhanced Analytical Procedure Development in Facilitating Post-Approval Changes Via Established Conditions
The Role of Enhanced Analytical Procedure Development in Facilitating Post-Approval Changes Via Established Conditions
Enabling greater flexibility for lifecycle management of analytical procedures is one of the primary features of the Inter...
Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities – a Workshop Report
Therapeutic Drug Monitoring of Biologics: Current Practice, Challenges and Opportunities – a Workshop Report
Therapeutic drug monitoring (TDM) for dose modification of biologics has the potential to improve patient outcomes. The US...
Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions
Characterizing the Hepatic Metabolic Pathway of Ketone Ester and Subsequent Metabolites Using Human and Rat Liver Fractions
Although exogenous ketogenic dietary supplements continue to grow in popularity, their pharmacokinetic properties have not...
Enhancing Efavirenz Bioavailability Via Polymer-Based Buccal Administration: Optimization and Characterization of Nanocrystal-Loaded Dissolving Microneedle Delivery Systems
Enhancing Efavirenz Bioavailability Via Polymer-Based Buccal Administration: Optimization and Characterization of Nanocrystal-Loaded Dissolving Microneedle Delivery Systems
Efavirenz (EFV) is a widely utilized antiretroviral agent in HIV/AIDS therapy that is known for its efficacy but is also a...
A Facile Way to Enhance the Therapeutic Efficacy of Hydrophobic Drugs via Amorphous Solid Dispersions
A Facile Way to Enhance the Therapeutic Efficacy of Hydrophobic Drugs via Amorphous Solid Dispersions
Approximately 40% of marketed drugs and 75% of invested drugs in the pharmaceutical field are poorly soluble hydrophobic d...
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