SCI Abstract

search
+
High Concordance of Total Antibody and Transduction Inhibition Assays Enables Replacement of Cell-Based Antibody Testing for Preexisting Anti-AAV Immunity in Cynomolgus Monkey
High Concordance of Total Antibody and Transduction Inhibition Assays Enables Replacement of Cell-Based Antibody Testing for Preexisting Anti-AAV Immunity in Cynomolgus Monkey
Testing for preexisting anti-AAV immunity in non-human primates constitutes an essential part of screening procedures for ...
Control Strategy Considerations for the Continuous Manufacturing of Low-dose Oral Solid Dosage Formulations
Control Strategy Considerations for the Continuous Manufacturing of Low-dose Oral Solid Dosage Formulations
The adoption of Continuous Manufacturing (CM) for Oral Solid Dosages (OSD) is often challenged by the limited sensitivity ...
Foreign Comparator Drug Products, Manufacturing & Supply Chain Considerations for Otic, Ophthalmic, And Parenteral Solutions – Generic Drugs Perspective
Foreign Comparator Drug Products, Manufacturing & Supply Chain Considerations for Otic, Ophthalmic, And Parenteral Solutions – Generic Drugs Perspective
In the United States (US), only the Food and Drug Administration (FDA)-approved drug products serve as comparator products...
Estimating Intragastric Disintegration Times of Immediate Release Dose Units Administered After a High-Calorie, High-Fat Meal Using Standardized, Commercially Available Equipment and Materials
Estimating Intragastric Disintegration Times of Immediate Release Dose Units Administered After a High-Calorie, High-Fat Meal Using Standardized, Commercially Available Equipment and Materials
Intragastric disintegration times of immediate release (IR) dose units after high-calorie, high-fat meal would be useful i...
In-depth Characterization of Photo-Stressed Antibody–Drug Conjugates by Mass Spectrometry
In-depth Characterization of Photo-Stressed Antibody–Drug Conjugates by Mass Spectrometry
Camptothecin (CPT)-based antibody–drug conjugates (ADCs) have become popular oncology biotherapeutics that integrate...
Applications of Thermoresponsive Hydrogels for Sustained Drug Release in Ocular and Intravitreal Formulations Treating Visual Impairments
Applications of Thermoresponsive Hydrogels for Sustained Drug Release in Ocular and Intravitreal Formulations Treating Visual Impairments
Vision loss is one of the most debilitating eye impairments, with the leading causes such as cataracts, glaucoma, injuries...
Nanotechnology-enhanced Natural Products for Cancer Chemoprevention: Molecular Mechanisms and Clinical Translation
Nanotechnology-enhanced Natural Products for Cancer Chemoprevention: Molecular Mechanisms and Clinical Translation
Cancer remains a major global health challenge. Natural compounds, such as curcumin, resveratrol, genistein, thymoquinone,...
Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing
Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing
Oligonucleotide therapeutics (ONTs) have emerged as a transformative treatment modality with numerous products approved gl...
HLA Class II Alleles DRB1*11:01 and DQB1*03:01 Unmask Immunogenetic Susceptibility to Anti-Nivolumab Antibodies in Combination with Ipilimumab
HLA Class II Alleles DRB1*11:01 and DQB1*03:01 Unmask Immunogenetic Susceptibility to Anti-Nivolumab Antibodies in Combination with Ipilimumab
Biologic combinations that modulate immune responses are increasingly used in oncology, enhancing anti-tumor immunity but ...
A Mechanistic Framework Integrating Renal QSP-PK-PD and Machine Learning for Baseline-Informed Stratification of Diuretic Resistance
A Mechanistic Framework Integrating Renal QSP-PK-PD and Machine Learning for Baseline-Informed Stratification of Diuretic Resistance
Diuretic resistance represents a major source of heterogeneity in loop diuretic response and remains a key barrier to effe...
Exploration of Colonic Mucus as A Dissolution Compartment for Orally Administered Drugs
Exploration of Colonic Mucus as A Dissolution Compartment for Orally Administered Drugs
Colonic mucus has gained interest as a dissolution compartment in the large intestine due to the large fraction of bound w...
Development and Implementation of a Hinderance-based Model for Porous Membranes
Development and Implementation of a Hinderance-based Model for Porous Membranes
In vitro release testing (IVRT) is an inexpensive and routine step in dermal formulation development where an inert membra...
New Frontiers of Drug Development Through the Use of New Approach Methodologies
New Frontiers of Drug Development Through the Use of New Approach Methodologies
On November 2025, AAPS PharmSci 360 convened a symposium that included experts in the application of various types of New ...
Context-of-use–Guided Development and Validation of a Transthyretin Immunoassay: A Framework for Biomarker Assay Design
Context-of-use–Guided Development and Validation of a Transthyretin Immunoassay: A Framework for Biomarker Assay Design
Transthyretin (TTR) is a circulating protein biomarker central to the evaluation of therapies for transthyretin amyloidosi...
Targeting Pyruvate Kinase M2: Signal Transduction Pathways and Exploration of Cancer Therapeutic Strategies
Targeting Pyruvate Kinase M2: Signal Transduction Pathways and Exploration of Cancer Therapeutic Strategies
The pathogenesis of cancer represents a multifaceted, progressive process driven by an intricate interplay of physical, ch...
Quantitative Estimation of Clinical Intrasubject Variability of a Pharmacokinetic Parameter
Quantitative Estimation of Clinical Intrasubject Variability of a Pharmacokinetic Parameter
The virtual bioequivalence (VBE) approach, which employs physiologically based pharmacokinetic (PBPK) modeling in lieu of ...
Guiding the Molnupiravir Tablet Formulation Using Physiologically Based Biopharmaceutics Modeling and Successfully Establishing Dissolution Safe Space
Guiding the Molnupiravir Tablet Formulation Using Physiologically Based Biopharmaceutics Modeling and Successfully Establishing Dissolution Safe Space
Physiologically Based Biopharmaceutics Models (PBBMs) are evolving tools which can be used to aid in drug product quality ...
Correction: Nanotechnology-enhanced Natural Products for Cancer Chemoprevention: Molecular Mechanisms and Clinical Translation
Correction: Nanotechnology-enhanced Natural Products for Cancer Chemoprevention: Molecular Mechanisms and Clinical Translation
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, whi...
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...
Load More
format_indent_increase