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A Bottom-up Approach for Mutant and Wild Type Collies Using Physiologically Based Pharmacokinetic (PBPK) Modeling: A Case Study Using Loperamide
A Bottom-up Approach for Mutant and Wild Type Collies Using Physiologically Based Pharmacokinetic (PBPK) Modeling: A Case Study Using Loperamide
A bottom-up physiologically based pharmacokinetic (PBPK) model was developed to predict the pharmacokinetics of loperamide...
A Comparative Study on Physicochemical and Analytical Characterizations of Doxil® and its Generic Drug Products
A Comparative Study on Physicochemical and Analytical Characterizations of Doxil® and its Generic Drug Products
Doxil®, a PEGylated liposomal doxorubicin (DOX) hydrochloride suspension, was the first liposome drug product approve...
The 100 Monoclonal Antibody Product is Approved in Japan
The 100 Monoclonal Antibody Product is Approved in Japan
The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese authority responsible for reviewing the quality, effic...
Improving the Therapeutic Selectivity of Trastuzumab Deruxtecan Using 8C2 Fab Fragments
Improving the Therapeutic Selectivity of Trastuzumab Deruxtecan Using 8C2 Fab Fragments
DXd, a camptothecin derivative, is employed as the payload molecule for the antibody–drug conjugate (ADC) trastuzuma...
Automation of Anti-Drug Antibody Enrichment Using Streptavidin PhyTip® Columns for Sample Pretreatment in an Immunogenicity Assay
Automation of Anti-Drug Antibody Enrichment Using Streptavidin PhyTip® Columns for Sample Pretreatment in an Immunogenicity Assay
The administration of biotherapeutics has the potential to induce potent immune responses, including the induction of anti...
Factors Impacting the Immunogenicity of Etrolizumab & Clinical Consequences
Factors Impacting the Immunogenicity of Etrolizumab & Clinical Consequences
Ulcerative colitis (UC) and Crohn's disease (CD), pose a substantial burden, necessitating effective therapies. Etroli...
Dose Optimization of ClpP Agonists Using an Microfluidic Perfusion Platform and Pharmacokinetic-Pharmacodynamic Modeling
Dose Optimization of ClpP Agonists Using an Microfluidic Perfusion Platform and Pharmacokinetic-Pharmacodynamic Modeling
Small molecule activators of the mitochondrial caseinolytic protease P (ClpP agonists) can disrupt tumor metabolism and de...
Effect of Alternative Administrations on P2Y12 Receptor Inhibitors’ Pharmacokinetics and Pharmacodynamics: Systematic Review and Meta-Analysis
Effect of Alternative Administrations on P2Y12 Receptor Inhibitors’ Pharmacokinetics and Pharmacodynamics: Systematic Review and Meta-Analysis
Alternative administrations methods, such as chewing or crushing tablets, have been proposed to improve P2Y12 receptor inh...
Pharmacokinetics and Pharmacodynamics of Nomlabofusp in Non-clinical Studies of Friedreich’s Ataxia
Pharmacokinetics and Pharmacodynamics of Nomlabofusp in Non-clinical Studies of Friedreich’s Ataxia
Nomlabofusp is a cell penetrant peptide-based recombinant fusion protein designed to enter cells and deliver human frataxi...
Enhanced Nanoprecipitation Method for the Production of PLGA Nanoparticles for Oncology Applications
Enhanced Nanoprecipitation Method for the Production of PLGA Nanoparticles for Oncology Applications
Herein, we report a new modified nanoprecipitation method for the fabrication of water-dispersible Poly(lactic-co-glycolic...
Dissolution of Oral Solid Dosage Formulations: Surrogate Models and Real-time Release
Dissolution of Oral Solid Dosage Formulations: Surrogate Models and Real-time Release
In vitro dissolution testing is commonly performed to ensure that oral solid dosage medicines are of high quality and will...
Procedural Variation May Contribute to 6-Minute Walk Distance Variability in Real-World Pediatric Pulmonary Arterial Hypertension Study
Procedural Variation May Contribute to 6-Minute Walk Distance Variability in Real-World Pediatric Pulmonary Arterial Hypertension Study
The six-minute walk test (6MWT) is a common method to assess submaximal exercise capacity in children and adults with pulm...
Simplifying Pharmacokinetics, Applying it to Drug and Dosage Form Development, and Making Drug Dosage Decisions in Clinical Medicine: The Adaptation of Kirchhoff’s Laws from Physics
Simplifying Pharmacokinetics, Applying it to Drug and Dosage Form Development, and Making Drug Dosage Decisions in Clinical Medicine: The Adaptation of Kirchhoff’s Laws from Physics
Over the past three years, we have published a series of nine manuscripts demonstrating that all relevant pharmacokinetic ...
Comparison of Surrogate Models in Tablet Dissolution Prediction: Addressing the Limitations of F₂ and Introducing Sum of Ranking Differences for Model Evaluation
Comparison of Surrogate Models in Tablet Dissolution Prediction: Addressing the Limitations of F₂ and Introducing Sum of Ranking Differences for Model Evaluation
As process analytical technology (PAT) and real-time release testing (RTRT) are gaining momentum in the pharmaceutical ind...
Doxorubicin Stability-indicating Method and its Main Degradation Products Toxicity
Doxorubicin Stability-indicating Method and its Main Degradation Products Toxicity
Human health and the environment are continuously impacted by anthropogenic activities, particularly those involving emerg...
Prospects and Challenges of Catechins in Cardiovascular Disease
Prospects and Challenges of Catechins in Cardiovascular Disease
Cardiovascular diseases (CVDs) have become one of the leading threats to human health due to their high incidence and mort...
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...
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