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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...
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...
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...
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...
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...
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...
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...
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...
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 ...
Determining the Degree of Sulfo-tag Conjugation to AAV5 Vectors by LC-HRMS and Evaluating the Effects on Antibody Binding Affinity and Bridging Assay Sensitivity
Determining the Degree of Sulfo-tag Conjugation to AAV5 Vectors by LC-HRMS and Evaluating the Effects on Antibody Binding Affinity and Bridging Assay Sensitivity
Pre-existing anti-AAV antibodies can be detected using ligand binding-based assay formats. One such format is the MSD-base...
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...
Design of Auto-Adaptive Drug Delivery System for Effective Delivery of Peptide Drugs to Overcoming Mucus and Epithelial Barriers
Design of Auto-Adaptive Drug Delivery System for Effective Delivery of Peptide Drugs to Overcoming Mucus and Epithelial Barriers
Oral administration of peptide represents a promising delivery route, however, it is hindered by the harsh gastrointestina...
ICH M10 Bioanalytical Method Validation Guideline-1 year Later
ICH M10 Bioanalytical Method Validation Guideline-1 year Later
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted Guid...
Liposomal Formulations of Anti-Alzheimer Drugs and siRNA for Nose-to-Brain Delivery: Design, Safety and Efficacy In Vitro
Liposomal Formulations of Anti-Alzheimer Drugs and siRNA for Nose-to-Brain Delivery: Design, Safety and Efficacy In Vitro
β-site amyloid precursor protein cleaving enzyme (BACE1) represents a key target for Alzheimer’s disease (AD) t...
A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection
A Risk-Based Assessment for Determining the Pharmacokinetic Comparability Requirements of Biologic-Device Combination Products Administered by Subcutaneous Injection
The development of new large molecule drug therapies along with the innovation of biologic-device combination products suc...
Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications
Mass Balance in Pharmaceutical Stress Testing: A Review of Principles and Practical Applications
Stress testing (also known as forced degradation) of pharmaceutical drug substances and products is a critical part of the...
Best Practices for Development and Validation of Enzymatic Activity Assays to Support Drug Development for Inborn Errors of Metabolism and Biomarker Assessment
Best Practices for Development and Validation of Enzymatic Activity Assays to Support Drug Development for Inborn Errors of Metabolism and Biomarker Assessment
Aberrant or dysfunctional cellular enzymes are responsible for a wide range of diseases including cancer, neurodegenerativ...
Modeling Metformin and Dapagliflozin Pharmacokinetics in Chronic Kidney Disease
Modeling Metformin and Dapagliflozin Pharmacokinetics in Chronic Kidney Disease
Chronic kidney disease (CKD) is a complication of diabetes that affects circulating drug concentrations and elimination of...
A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions
A Perspective on Evaluating Life Stage Differences in Drug Dosages for Drug Labeling and Instructions
Drug labeling and instructions provide essential information for patients regarding the usage of drugs. Instructions for t...
Non-Invasive, Continuous, Quantitative Detection of Solvent Content in Vacuum Tray Drying
Non-Invasive, Continuous, Quantitative Detection of Solvent Content in Vacuum Tray Drying
A non-invasive capacitance instrument was embedded in the base of a vacuum-drying tray to monitor continuously the residua...
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2
The Development of Epitope-Based Recombinant Protein Vaccines against SARS-CoV-2
The COVID-19 pandemic continues to cause infections and deaths, which are attributable to the SARS-CoV-2 Omicron variant o...
Predicting Tumor Volume Doubling Time and Progression-Free Survival in Untreated Patients from Patient-Derived-Xenograft (PDX) Models: A Translational Model-Based Approach
Predicting Tumor Volume Doubling Time and Progression-Free Survival in Untreated Patients from Patient-Derived-Xenograft (PDX) Models: A Translational Model-Based Approach
Tumor volume doubling time (TVDT) has been shown to be a potential surrogate marker of biological tumor activity. However,...
Blood–Brain Barrier Permeability is Affected by Changes in Tight Junction Protein Expression at High-Altitude Hypoxic Conditions—this may have Implications for Brain Drug Transport
Blood–Brain Barrier Permeability is Affected by Changes in Tight Junction Protein Expression at High-Altitude Hypoxic Conditions—this may have Implications for Brain Drug Transport
Changes to blood–brain barrier structure and function may affect the delivery of drugs into the brain. It is worthwh...
An Investigation of In Vitro Anti-Cancer Efficacy of Dihydroartemisinin-Loaded Bovine Milk Exosomes Against Triple-Negative Breast Cancer
An Investigation of In Vitro Anti-Cancer Efficacy of Dihydroartemisinin-Loaded Bovine Milk Exosomes Against Triple-Negative Breast Cancer
Repurposing drugs offers several advantages, including reduced time and cost compared to developing new drugs from scratch...
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices
Recommendations for Development and Validation of a Fit-For-Purpose Biomarker Assays Using Western Blotting; An-AAPS Sponsored Initiative to Harmonize Industry Practices
Western blot (WB) assays are routinely used for detection and quantification of biomarkers. Although assay validation to m...
A Data Driven Strategy and Case Study for Implementation of Singlicate Analysis in Ligand Binding Assays Used for PK Quantitation
A Data Driven Strategy and Case Study for Implementation of Singlicate Analysis in Ligand Binding Assays Used for PK Quantitation
Duplicate analysis has been a conventional practice in the industry for ligand-binding assays (LBA), particularly for plat...
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation
Evaluating the Performance of Two Automated Anti-drug Antibodies Assays for Infliximab and Adalimumab Without Acid Dissociation
Monitoring anti-drug antibodies (ADAs) to infliximab and adalimumab is critical to treatment management in various autoimm...
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022
Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013–2022
The effectiveness of the regulatory initiatives, strategies, and incentives put forth in the first two authorizations of t...
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...
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