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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 ...
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...
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 ...
Raltegravir Plasma Exposure: A Machine Learning-Based Model for its Prediction Using Limited Sampling Strategy
Raltegravir Plasma Exposure: A Machine Learning-Based Model for its Prediction Using Limited Sampling Strategy
Recent studies have applied machine learning (ML)-based limited sampling strategies (LSS) to predict drug exposure (AUC), ...
Evaluating the Utility and Constraints of the Competitive Counter Flow (CCF) Assay in OATP1B1 Substrate Profiling
Evaluating the Utility and Constraints of the Competitive Counter Flow (CCF) Assay in OATP1B1 Substrate Profiling
The organic anion transporting polypeptide 1B1 (OATP1B1) plays a critical role in hepatic uptake of a wide range of high- ...
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...
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...
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...
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 ...
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...
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