Research Articles
Why Analytical Method Validation Parameters Are Critical: Ensuring Accuracy, Compliance, and Innovation in Drug Development
This article provides a comprehensive overview of analytical method validation for researchers, scientists, and drug development professionals.
Surrogate and Global Optimization in Chemistry: Fundamentals, Methods, and Applications in Drug Discovery
This article provides a comprehensive overview of surrogate-based and global optimization strategies essential for tackling complex, computationally expensive problems in chemical research and drug development.
Sequential Simplex Optimization: A Practical Guide for Drug Development and Biomedical Research
This article provides a comprehensive guide to Sequential Simplex Optimization, a powerful model-agnostic technique for improving quality and productivity in research and development.
Paradigm Shift in Analytical Chemistry: AI, Sustainability, and Regulatory Evolution Reshaping Biomedical Research
This article explores the transformative evolution of analytical chemistry, driven by artificial intelligence, green principles, and modernized regulations.
Analytical Chemistry: The Enabling Science Powering Modern Drug Development and Biomedical Research
This article explores the indispensable role of analytical chemistry as a foundational enabler across the biomedical and pharmaceutical sciences.
Correcting Baseline Drift in UV-Vis Spectroscopy: A Complete Guide for Robust Pharmaceutical Analysis
This article provides a comprehensive guide for researchers and drug development professionals on addressing baseline drift in UV-Vis spectroscopy. Covering foundational principles to advanced applications, it details the root causes of drift—from mobile phase effects and temperature fluctuations to instrumental artifacts. The scope includes practical methodologies for baseline correction, targeted troubleshooting protocols for common HPLC and spectrophotometry issues, and validation strategies ensuring data integrity compliant with modern regulatory standards. By integrating traditional techniques with emerging machine learning approaches, this resource aims to enhance measurement accuracy and reliability in biomedical research and quality control.
UFLC-DAD in High-Throughput Screening: Accelerating Drug Discovery and Bioanalysis
Ultra-Fast Liquid Chromatography with Diode Array Detection (UFLC-DAD) has emerged as a pivotal analytical technique for high-throughput screening (HTS) in modern drug discovery and development. This article explores the integral role of UFLC-DAD in providing rapid, sensitive, and reliable analytical data crucial for evaluating pharmacokinetic properties, screening compound libraries, and ensuring the quality and safety of pharmaceutical agents. Tailored for researchers, scientists, and drug development professionals, we cover the foundational principles of UFLC-DAD, its methodological applications in biomimetic chromatography and ADMET profiling, strategies for troubleshooting and system optimization, and its comparative validation against other HTS platforms. By synthesizing current methodologies and practical applications, this review provides a comprehensive framework for leveraging UFLC-DAD to significantly accelerate compound screening and streamline the drug development pipeline.
UFLC-DAD in Pharmaceutical Analysis: Practical Applications, Method Development, and Validation for Modern Labs
This article provides a comprehensive overview of the practical applications of Ultra-Fast Liquid Chromatography with Diode Array Detection (UFLC-DAD) in pharmaceutical analysis. Tailored for researchers, scientists, and drug development professionals, it explores the foundational principles of UFLC-DAD, details its methodological use in quantifying active ingredients and studying drug release, addresses common troubleshooting and optimization strategies, and establishes its validity through comparative analysis with other techniques. The content synthesizes current research and case studies to offer a actionable guide for implementing robust, efficient, and compliant UFLC-DAD methods in quality control and research laboratories.
Robustness Testing in Comparative Method Validation: A Strategic Guide for Pharmaceutical Scientists
This article provides a comprehensive guide to robustness testing within comparative analytical method validation, tailored for researchers and drug development professionals. It covers foundational principles, defining robustness and its critical role in ensuring method reliability per ICH and USP guidelines. The content explores advanced methodological approaches, including experimental design (DoE) and practical case studies from pharmaceutical analysis. It also addresses common troubleshooting scenarios and optimization strategies, concluding with frameworks for comparative assessment and system suitability to ensure regulatory compliance and successful method transfer.
Navigating Global Validation Guidelines: A Comparative Analysis of ICH, EMA, and WHO Requirements for Pharmaceutical Professionals
This article provides a comprehensive comparative analysis of analytical and process validation guidelines from the ICH, EMA, and WHO. Tailored for researchers, scientists, and drug development professionals, it explores the foundational principles, methodological applications, and practical challenges of adhering to multiple regulatory frameworks. The content synthesizes current regulatory requirements, including the updated ICH Q2(R2) and the lifecycle approach, to offer strategic insights for optimizing validation strategies, ensuring global compliance, and enhancing operational efficiency in pharmaceutical development and manufacturing.