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Taurine, a Naturally Occurring Amino Acid, as a Physical Stability Enhancer of Different Monoclonal Antibodies
Taurine, a Naturally Occurring Amino Acid, as a Physical Stability Enhancer of Different Monoclonal Antibodies
Degradation of therapeutic monoclonal antibodies (mAbs) is a major concern as it affects efficacy, shelf-life, and safety ...
Characterization of CYP3A5 Selective Inhibitors for Reaction Phenotyping of Drug Candidates
Characterization of CYP3A5 Selective Inhibitors for Reaction Phenotyping of Drug Candidates
CYP3A is one of the most important classes of enzymes and is involved in the metabolism of over 70% drugs. While several s...
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development
The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for the...
An Explanation of Why Dose-Corrected Area Under the Curve for Alternate Administration Routes Can Be Greater than for Intravenous Dosing
An Explanation of Why Dose-Corrected Area Under the Curve for Alternate Administration Routes Can Be Greater than for Intravenous Dosing
It is generally believed that bioavailability (F) calculated based on systemic concentration area under the curve (AUC) me...
Successful Development of Nonclinical Anti-Drug Antibody Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies
Successful Development of Nonclinical Anti-Drug Antibody Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies
Immunogenicity assessment is an essential part of biotherapeutic drug development. While the immune response in animals is...
Connexin-Containing Vesicles for Drug Delivery
Connexin-Containing Vesicles for Drug Delivery
Connexin is a transmembrane protein present on the cell membrane of most cell types. Connexins assemble into a hexameric h...
Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development
Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development
On October 27–28, 2022, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics (C...
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay
Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay
Non-neutralizing anti-idiotype antibodies against a therapeutic monoclonal antibody (mAb) play a crucial role in the creat...
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products
Using Mechanistic Modeling Approaches to Support Bioequivalence Assessments for Oral Products
This report summarizes the proceedings for Day 1 Session 3 of the 2-day public workshop entitled “Best Practices for...
Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models
Comparison of Two Methods for Determining Item Characteristic Functions and Latent Variable Time-Course for Pharmacometric Item Response Models
There are examples in the literature demonstrating different approaches to defining the item characteristic functions (ICF...
Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report
Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report
This report summarizes relevant insights and discussions from a 2022 FDA public workshop titled Best Practices for Utilizi...
Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products
Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products
Evidence shows that there is an increasing use of modeling and simulation to support product development and approval for ...
A Bispecific Modeling Framework Enables the Prediction of Efficacy, Toxicity, and Optimal Molecular Design of Bispecific Antibodies Targeting MerTK
A Bispecific Modeling Framework Enables the Prediction of Efficacy, Toxicity, and Optimal Molecular Design of Bispecific Antibodies Targeting MerTK
Inhibiting MerTK on macrophages is a promising therapeutic strategy for augmenting anti-tumor immunity. However, blocking ...
Design, Synthesis, and Biochemical Analysis of a Molecule Designed to Enhance Endosomal Escape
Design, Synthesis, and Biochemical Analysis of a Molecule Designed to Enhance Endosomal Escape
RNA therapeutics, including siRNAs, ASOs, and PMOs, have great potential to treat human disease. However, RNA therapeutics...
Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19
Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19
The FDA initiated a cross-sectional, statistically based sampling and testing study to characterize the quality of markete...
Notes on the Use of Kirchhoff’s Laws in Pharmacokinetics
Notes on the Use of Kirchhoff’s Laws in Pharmacokinetics
Recent publications by Benet and coworkers, Korzekwa and Nagar, and Rowland et al. signal disagreement regarding the use o...
Pharmacodynamics of Cyclin D1 Degradation in Ovarian Cancer Xenografts with Repeated Oral SHetA2 Dosing
Pharmacodynamics of Cyclin D1 Degradation in Ovarian Cancer Xenografts with Repeated Oral SHetA2 Dosing
SHetA2 is a promising, orally active small molecule with anticancer properties that target heat shock proteins. In this st...
Therapeutic Fusion Proteins
Therapeutic Fusion Proteins
Therapeutic fusion proteins are a class of hybrid constructs that combine distinct biomolecules into a single platform wit...
Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development
Clinical Bridging Studies and Modeling Approach for Implementation of a Patient Centric Sampling Technique in Padsevonil Clinical Development
Volumetric absorptive microsampling (VAMS) techniques have gained popularity these last years as innovative tool for colle...
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors
Interspecies Scaling of Transgene Products for Viral Vector Gene Therapies: Method Assessment Using Data from Eleven Viral Vectors
The prediction of transgene product expression in human is important to guide first-in-human (FIH) dose selection for vira...
A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications
A Novel Milli-fluidic Liver Tissue Chip with Continuous Recirculation for Predictive Pharmacokinetics Applications
A crucial step in lead selection during drug development is accurate estimation and optimization of hepatic clearance usin...
Tuning the Emulsion Properties Influences the Size of Poly(Caprolactone) Particles for Drug Delivery Applications
Tuning the Emulsion Properties Influences the Size of Poly(Caprolactone) Particles for Drug Delivery Applications
Advances in drug delivery have been accelerated with the addition of polymeric drug carriers. Direct delivery to a target ...