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Planning Split-Apheresis Designs for Demonstrating Comparability of Cellular and Gene Therapy Products
Planning Split-Apheresis Designs for Demonstrating Comparability of Cellular and Gene Therapy Products
A recent FDA draft guidance discusses statistical considerations for demonstrating comparability of cell and gene therapy ...
Evaluating AlphaFold for Clinical Pharmacology and Pharmacogenetics: A Case-Study of Huntingtin Variants Linked to Huntington’s Disease
Evaluating AlphaFold for Clinical Pharmacology and Pharmacogenetics: A Case-Study of Huntingtin Variants Linked to Huntington’s Disease
To evaluate the artificial intelligence (AI)-guided AlphaFold algorithm for studying the binding interactions of human hun...
UGT2B10 is the Major UDP-Glucuronosyltransferase 2B Isoform Involved in the Metabolism of Lamotrigine and is Implicated in the Drug-Drug Interaction with Valproic Acid
UGT2B10 is the Major UDP-Glucuronosyltransferase 2B Isoform Involved in the Metabolism of Lamotrigine and is Implicated in the Drug-Drug Interaction with Valproic Acid
Lamotrigine is a phenyltriazine anticonvulsant that is primarily metabolized by phase II UDP-glucuronosyltransferases (UGT...
Temperature Excursion Management: A Tier-Based Approach for Commercial Oral Solid Dosage Forms
Temperature Excursion Management: A Tier-Based Approach for Commercial Oral Solid Dosage Forms
Temperature excursions during product storage, transportation, and handling can deteriorate product quality. Following a t...
Assessing Immunogenicity in Drug Reviews and Prescribing Information in Japan
Assessing Immunogenicity in Drug Reviews and Prescribing Information in Japan
Anti-drug antibodies (ADAs) generated in response to biopharmaceuticals can significantly impact pharmacokinetics (PK) and...
Case Studies on the use of Microsampling for Nonclinical Studies in Pharmaceutical Drug Discovery and Development
Case Studies on the use of Microsampling for Nonclinical Studies in Pharmaceutical Drug Discovery and Development
The implementation of microsampling approaches for use in nonclinical discovery and development pharmaceutical studies can...
Luteolin Protects against Vascular Calcification by Modulating SIRT1/CXCR4 Signaling Pathway and Promoting Autophagy
Luteolin Protects against Vascular Calcification by Modulating SIRT1/CXCR4 Signaling Pathway and Promoting Autophagy
Vascular calcification (VC) is a common pathological manifestation of atherosclerosis, hypertension, diabetes vascular dis...
Exploring the Impact of Pharmacological Target-Mediated Low Plasma Exposure in Lead Compound Selection in Drug Discovery – A Modeling Approach
Exploring the Impact of Pharmacological Target-Mediated Low Plasma Exposure in Lead Compound Selection in Drug Discovery – A Modeling Approach
Small-molecule drug development faces the challenge of low success rate. In this paper, we propose one potential cause tha...
Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009–2023
Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009–2023
Generics and biosimilars play an important role in sustaining the universal healthcare insurance systems in Japan. The Pha...
Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/Bypass
Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/Bypass
Bariatric surgery introduces significant changes in the gastrointestinal tract, which may affect oral drug absorption/bioa...
Precision Nanomedicine: Lapatinib-Loaded Chitosan-Gold Nanoparticles Targeting LINC01615 for Lung Cancer Therapy
Precision Nanomedicine: Lapatinib-Loaded Chitosan-Gold Nanoparticles Targeting LINC01615 for Lung Cancer Therapy
Long non-coding RNAs (lncRNAs) play essential roles as oncogenic factors in cancer progression by influencing cell prolife...
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent
Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent
The article focuses on preparing a nanoformulation based on hydrotalcite and glycyrrhizic acid (GA), seeking a hepatoprote...
A Data Driven Strategy for Implementation of Singlicate Analysis in Ligand Binding Assays Used for the Determination of Anti-drug Antibodies to a Multidomain Biotherapeutic
A Data Driven Strategy for Implementation of Singlicate Analysis in Ligand Binding Assays Used for the Determination of Anti-drug Antibodies to a Multidomain Biotherapeutic
A stepwise, data-driven approach for Anti-Drug Antibodies (ADA) singlicate assays has been developed to evaluate the feasi...
Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab
Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab
Immunogenicity assessment is vital in clinical trials and is measured through a multi-tiered approach (screening, confirma...
Exploring the Correlation between LC–MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis
Exploring the Correlation between LC–MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis
Biotherapeutics are subject to inherent heterogeneity due to the complex biomanufacturing processes. Numerous analytical t...
Development of Solidified Self-microemulsifying Delivery Systems Containing Tacrolimus for Enhanced Dissolution and Pharmacokinetic Profile
Development of Solidified Self-microemulsifying Delivery Systems Containing Tacrolimus for Enhanced Dissolution and Pharmacokinetic Profile
The use of tacrolimus (FK506) as an immunosuppressant is limited by its low aqueous solubility and bioavailability. The se...
Tumor-Infiltration Mimicking Model of Contaminated Ovarian Tissue as an Innovative Platform for Advanced Cancer Research
Tumor-Infiltration Mimicking Model of Contaminated Ovarian Tissue as an Innovative Platform for Advanced Cancer Research
The development of advanced preclinical models is crucial for the evaluation and validation of novel therapeutic strategie...
Recommendation for Clarifying FDA Policy in Evaluating “Sameness” of Higher Order Structure for Generic Peptide Therapeutics
Recommendation for Clarifying FDA Policy in Evaluating “Sameness” of Higher Order Structure for Generic Peptide Therapeutics
Recognizing the approach of a dramatic expansion of peptide therapeutics reaching the marketplace in recent years, led by ...
Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation
Quantitative Analysis of Physical Stability Mechanisms of Amorphous Solid Dispersions by Molecular Dynamic Simulation
Amorphous solid dispersions (ASDs) represent a promising strategy for enhancing the solubility of poorly soluble drugs. Ho...
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...
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-...
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...
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...
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