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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-...
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...
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...
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...
Doses Evaluated in Clinical Pharmacology Studies Investigating the Effect of Intrinsic and Extrinsic Factors on PK and Safety: Case Examples from Approved Drug Development Programs
Doses Evaluated in Clinical Pharmacology Studies Investigating the Effect of Intrinsic and Extrinsic Factors on PK and Safety: Case Examples from Approved Drug Development Programs
Dose selection for investigations of intrinsic and extrinsic factors of pharmacokinetic variability as well as safety is a...
Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis
Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis
We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether th...
3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues?
3-CMC, 4-CMC, and 4-BMC Human Metabolic Profiling: New Major Pathways to Document Consumption of Methcathinone Analogues?
Synthetic cathinones represent one of the largest and most abused new psychoactive substance classes, and have been involv...
Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?
Playing Hide-and-Seek with Tyrosine Kinase Inhibitors: Can We Overcome Administration Challenges?
Tyrosine kinase inhibitors (TKIs) have demonstrated significant efficacy against various types of cancers through molecula...
Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents
Design of Crosslinking Antibodies For T-Cell Activation: Experimental and Computational Analysis of PD-1/CD137 Bispecific Agents
Bispecific and multispecific agents have become increasingly utilized in cancer treatment and immunotherapy, yet their com...
Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space
Physiologically Based Biopharmaceutics Modeling for Gefapixant IR Formulation Development and Defining the Bioequivalence Dissolution Safe Space
Gefapixant is a weakly basic drug which has been formulated as an immediate release tablet for oral administration. A phys...
Simulating Healthy Participant Pharmacokinetics for Renal and Hepatic Impairment Studies: Retrospective Assessment of the Approach
Simulating Healthy Participant Pharmacokinetics for Renal and Hepatic Impairment Studies: Retrospective Assessment of the Approach
The recruitment of a parallel, healthy participants (HPs) arm in renal and hepatic impairment (RI and HI) studies is a com...
Machine-Learning Assisted Screening of Correlated Covariates: Application to Clinical Data of Desipramine
Machine-Learning Assisted Screening of Correlated Covariates: Application to Clinical Data of Desipramine
Stepwise covariate modeling (SCM) has a high computational burden and can select the wrong covariates. Machine learning (M...
Impact on Quality during In-Use Preparation of an Antibody Drug Conjugate with Eight Different Closed System Transfer Device Brands
Impact on Quality during In-Use Preparation of an Antibody Drug Conjugate with Eight Different Closed System Transfer Device Brands
The aim of this study was to investigate the in-use compatibility of eight commercially available closed system transfer d...
Impact of Obesity on Hepatic Drug Clearance: What are the Influential Variables?
Impact of Obesity on Hepatic Drug Clearance: What are the Influential Variables?
Drug clearance in obese subjects varies widely among different drugs and across subjects with different severity of obesit...
Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route
Anti-Drug Antibody Incidence Comparison of Therapeutic Proteins Administered Via Subcutaneous vs. Intravenous Route
Subcutaneous (SC) administration of therapeutic proteins is perceived to pose higher risk of immunogenicity when compared ...
Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis-Hastings Algorithm
Uncertainty Computation at Finite Distance in Nonlinear Mixed Effects Models—a New Method Based on Metropolis-Hastings Algorithm
The standard errors (SE) of the maximum likelihood estimates (MLE) of the population parameter vector in nonlinear mixed e...
Prediction of Individual Disease Progression Including Parameter Uncertainty in Rare Neurodegenerative Diseases: The Example of Autosomal-Recessive Spastic Ataxia Charlevoix Saguenay (ARSACS)
Prediction of Individual Disease Progression Including Parameter Uncertainty in Rare Neurodegenerative Diseases: The Example of Autosomal-Recessive Spastic Ataxia Charlevoix Saguenay (ARSACS)
The aim of this study was to develop a model to predict individual subject disease trajectories including parameter uncert...
Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability
Pharmacokinetic Models for Inhaled Fluticasone Propionate and Salmeterol Xinafoate to Quantify Batch-to-Batch Variability
Advair Diskus is an essential treatment for asthma and chronic obstructive pulmonary disease. It is a dry powder inhaler w...
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling
Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling
This work shows the utilization of a physiologically based biopharmaceutics model (PBBM) to mechanistically explain the im...
Third Generation Solid Dispersion-Based Formulation of Novel Anti-Tubercular Agent Exhibited Improvement in Solubility, Dissolution and Biological Activity
Third Generation Solid Dispersion-Based Formulation of Novel Anti-Tubercular Agent Exhibited Improvement in Solubility, Dissolution and Biological Activity
The long treatment period and development of drug resistance in tuberculosis (TB) necessitates the discovery of new anti-t...
Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method
Implementation of a Three-Way Comparability Assessment for a Bioanalytical Anti-Drug Antibody Method
Immunogenicity evaluation is a critical part of drug development. Regulatory guidelines from multiple health agencies prov...
Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies
Group-by-Treatment Interaction Effects in Comparative Bioavailability Studies
Comparative bioavailability studies often involve multiple groups of subjects for a variety of reasons, such as clinical c...
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...
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