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Proactive Approaches to cGMP Compliance: Insights and Key Takeaways from USFDA Warning Letters to Pharmaceutical Industries Between 2019 and 2024
Proactive Approaches to cGMP Compliance: Insights and Key Takeaways from USFDA Warning Letters to Pharmaceutical Industries Between 2019 and 2024
This study aims to meticulously analyse the trends and recurrent challenges that emerge from Warning Letters (WLs) issued ...
Assessment of the Effect of Microneedle Pretreatment on Permeation of Hydrophilic and Hydrophobic Drugs Through Burn Eschar
Assessment of the Effect of Microneedle Pretreatment on Permeation of Hydrophilic and Hydrophobic Drugs Through Burn Eschar
Here, utilizing of microneedle roller as a physical enhancer of drug permeation through third-degree burn eschar has been ...
Increasing the Stability of Pellets Containing Lycopene by Using Dual-Coating
Increasing the Stability of Pellets Containing Lycopene by Using Dual-Coating
Lycopene (LYC) is a natural carotenoid, which has antioxidant, anti-inflammatory and anti-cancer properties. Nevertheless,...
Formulation, Evaluation and Optimization of Acitretin Loaded Transethosomes for the Management of Psoriasis
Formulation, Evaluation and Optimization of Acitretin Loaded Transethosomes for the Management of Psoriasis
Psoriasis is a chronic inflammatory skin disorder characterized by the development of red, scaly patches (National Psorias...
Insight into Binding and Interaction of Docking, Dynamics and Network Pharmacology to Explore the Target on Cancer Inhibitors
Insight into Binding and Interaction of Docking, Dynamics and Network Pharmacology to Explore the Target on Cancer Inhibitors
The bioefficacy of accessible chemical structures has been established, leading to some optimization to address these cons...
Formulation, Optimization and In Vitro Studies of Flutamide-loaded Nanostructured Lipid Carrier Based Oral Drug Delivery for Enhanced Anticancer Activity
Formulation, Optimization and In Vitro Studies of Flutamide-loaded Nanostructured Lipid Carrier Based Oral Drug Delivery for Enhanced Anticancer Activity
The purpose of this study was to formulate and evaluate nanostructured lipid carriers (NLCs) of the poorly water soluble a...
Accelerated Approval for Cancer Drugs in the United States and the Clinical Evidence Required for Conversion to Regular Approval
Accelerated Approval for Cancer Drugs in the United States and the Clinical Evidence Required for Conversion to Regular Approval
Oncology products often leverage accelerated approval program to seek earlier launches in the United States. Little is kno...
Assessment of the HaLCon® Protein Analyzer for At-Line Titer Measurements in Biomanufacturing Applications
Assessment of the HaLCon® Protein Analyzer for At-Line Titer Measurements in Biomanufacturing Applications
With the increasing demand for intensified processes in biopharmaceutical manufacturing, there is a growing requirement fo...
Development and In-Vitro Characterization of Capsaicin Microsponges Loaded Topical Gels for Management of Arthritis
Development and In-Vitro Characterization of Capsaicin Microsponges Loaded Topical Gels for Management of Arthritis
Arthritis is the one of the leading causes of disability among a large group of population. It is a slowly progressive dis...
Improving Continuous Loss-in-weight Feeding Accuracy by a Novel Hopper Design
Improving Continuous Loss-in-weight Feeding Accuracy by a Novel Hopper Design
Powder feeding is a vital unit operation in the continuous manufacturing of pharmaceutical products. Loss-in-weight twin-s...
Improving the Doxorubicin Loading to PLGA Nanoparticles with TOPSIS-Based Taguchi Design Approach: Effect of the Water Phase
Improving the Doxorubicin Loading to PLGA Nanoparticles with TOPSIS-Based Taguchi Design Approach: Effect of the Water Phase
PLGA nanoparticles are one of the most investigated drug delivery systems among all polymeric nanoparticles. Although ther...
Preparation and Characterization of Electrospun Polyvinylpyrrolidone Nanofiber Mat Containing Phillyrea Latifolia L. Herbal Extract and Evaluation of Antioxidant Mechanism
Preparation and Characterization of Electrospun Polyvinylpyrrolidone Nanofiber Mat Containing Phillyrea Latifolia L. Herbal Extract and Evaluation of Antioxidant Mechanism
Fast-disintegrating dosage forms based on nanofibers hold promise as effective carriers for a diverse array of drugs. In t...
Quality by Design (QbD) Enabled and Central-Composite Design Assisted Approach for Formulation of Oral Herbal Gastro-retentive In-situ Gel
Quality by Design (QbD) Enabled and Central-Composite Design Assisted Approach for Formulation of Oral Herbal Gastro-retentive In-situ Gel
The delivery of herbal medications is currently a growing area in pharmacy. One of the areas of interest for the scientist...
Development and Implementation of a Comprehensive Initiative to Educate Healthcare Providers and Patients in the United States about the Risk of Drug-Drug Interactions Associated with Nirmatrelvir/ritonavir during the COVID-19 Pandemic
Development and Implementation of a Comprehensive Initiative to Educate Healthcare Providers and Patients in the United States about the Risk of Drug-Drug Interactions Associated with Nirmatrelvir/ritonavir during the COVID-19 Pandemic
This case study describes the development of a comprehensive drug-drug interaction (DDI) education initiative for nirmatre...
Ensuring Product Safety: A Comprehensive Retrospective Study of USFDA Drug Recalls (2019–2023)
Ensuring Product Safety: A Comprehensive Retrospective Study of USFDA Drug Recalls (2019–2023)
Despite stringent regulations enforced by the United States Food and Drug Administration (USFDA), numerous drug products s...
Targeting Cancer with Sweet Precision: Saccharide-Grafted Erlotinib for Enhanced Drug Delivery
Targeting Cancer with Sweet Precision: Saccharide-Grafted Erlotinib for Enhanced Drug Delivery
This study aims to enhance the targeting of erlotinib by grafting saccharides—galactose, pectin, and chitosan via ox...
Optimizing Nateglinide Liquisolid Compacts: Achieving Formulation Excellence Through the Quality by Design Approach
Optimizing Nateglinide Liquisolid Compacts: Achieving Formulation Excellence Through the Quality by Design Approach
The present study aimed to improve the dissolution properties of nateglinide, an anionic drug with poor water solubility a...
Sustained Release of Liposomal Caffeine Using Novel Natural Fiber Interlaced Liposomal Technology: Development and Structural Characterisation
Sustained Release of Liposomal Caffeine Using Novel Natural Fiber Interlaced Liposomal Technology: Development and Structural Characterisation
Caffeine is a naturally occurring central nervous system stimulant, susceptible to absorb faster in the body, and new desi...
Design and Critical Characterization the Pharmaceutical Cocrystal of Azelnidipine With Coformers for Boosting Physicochemical Properties
Design and Critical Characterization the Pharmaceutical Cocrystal of Azelnidipine With Coformers for Boosting Physicochemical Properties
Azelnidipine, a BCS class II antihypertensive medication, is known for its low solubility and high permeability. In order ...
A Dynamic Model for GMP Compliance and Regulatory Science
A Dynamic Model for GMP Compliance and Regulatory Science
To propose a dynamic model designed to investigate the underlying principles of regulatory science and assess the effectiv...
Osteocompatible Zinc-Copper Substituted Hydroxyapatite Reinforced Biocomposites for Bone Tissue Regeneration
Osteocompatible Zinc-Copper Substituted Hydroxyapatite Reinforced Biocomposites for Bone Tissue Regeneration
The main purposes of this study were to explore a unique approach for producing nano-hierarchical morphological hydroxyapa...
Silver Sulfadiazine Nanocrystal-Based Hydrogels: The Impact of Lipid Components on In-vitro and Ex-vivo Release, Bacterial Biofilm Permeability, and In-vitro Antibacterial Activity
Silver Sulfadiazine Nanocrystal-Based Hydrogels: The Impact of Lipid Components on In-vitro and Ex-vivo Release, Bacterial Biofilm Permeability, and In-vitro Antibacterial Activity
This study developed a new formulation for silver sulfadiazine (SSD) nanocrystal-based hydrogels for in vitro antimicrobia...
The Application of Box-Behnken-Design in the Optimization of Kinetic Spectrophotometry and Computational Studies to Determine and Assessing Eco-Scale to Green Analytical Chemistry for Labetalol
The Application of Box-Behnken-Design in the Optimization of Kinetic Spectrophotometry and Computational Studies to Determine and Assessing Eco-Scale to Green Analytical Chemistry for Labetalol
The study is aimed at the quantitative analysis of Labetalol utilizing Box-Benken design, where higher order response surf...
Challenges at Submicron Particle Characterisation: A Case Study Using Nanoparticle Tracking Analysis (NTA)
Challenges at Submicron Particle Characterisation: A Case Study Using Nanoparticle Tracking Analysis (NTA)
Nanoparticle tracking analysis (NTA) is an emerging technique for the analysis of particles in the submicron range of 50&#...
Has the Establishment of a FTZ Promoted the High-quality Development of the Pharmaceutical Manufacturing Industry?——Quasi Natural Experiments Based on the Establishment of the First Three Batches of Pilot FTZ
Has the Establishment of a FTZ Promoted the High-quality Development of the Pharmaceutical Manufacturing Industry?——Quasi Natural Experiments Based on the Establishment of the First Three Batches of Pilot FTZ
As a strategic emerging and high-tech industry in China, the pharmaceutical industry is significantly impacted by the esta...
Green Synthesis of Silver Nanoparticles by Using Anthemis Tricolor Boiss., Factorial Design for Parameter Optimization, Characterization and In-Vitro Biological Activities
Green Synthesis of Silver Nanoparticles by Using Anthemis Tricolor Boiss., Factorial Design for Parameter Optimization, Characterization and In-Vitro Biological Activities
The objectives of the study are to obtain silver nanoparticles using Anthemis tricolor in an environmentally friendly, eco...
Fabrication, Physicochemical Characterization, and in Silico Evaluation of Bilayer Nanofibers as a Potential Sustained Crocin Delivery Dressing
Fabrication, Physicochemical Characterization, and in Silico Evaluation of Bilayer Nanofibers as a Potential Sustained Crocin Delivery Dressing
This research aimed to produce zein-based bilayer nanofibers to sustain the release of crocin. Zein and gelatin were blend...
Development, Comparison, and Qualification of Predictive Pharmaceutical Stability Models Using Independent Statistical Tools
Development, Comparison, and Qualification of Predictive Pharmaceutical Stability Models Using Independent Statistical Tools
The predictive modeling approach to assess long-term stability performance of pharmaceuticals by using short-term accelera...
A Communication Effectiveness Study of the FDA GMP Warning Letters
A Communication Effectiveness Study of the FDA GMP Warning Letters
Study the structure and content trend over time of the FDA GMP Warning Letters for their roles in effective communication....
Systematic Development of Hot Melt Extrusion-Based Amorphous Solid Dispersion: Integrating Quality by Design and In Silico Modeling
Systematic Development of Hot Melt Extrusion-Based Amorphous Solid Dispersion: Integrating Quality by Design and In Silico Modeling
The study aimed to develop and optimize apremilast (APST) solid dispersion formulations using copovidone (Kollidon VA64) a...
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