Analytical & Bioanalytical Method Validation
Validating Dissolution Methods for Orally Disintegrating and Fast-Dissolve Tablets Validating Dissolution Methods for Orally Disintegrating and Fast-Dissolve Tablets This regulatory explainer manual covers the validation of dissolution methods specifically designed for orally disintegrating tablets (ODTs) and fast-dissolve dosage forms. ODTs are unique pharmaceuticals that dissolve in the mouth without the need for water, prompting specific considerations for method validation. With…
Statistical Evaluation of Dissolution Data in Method Validation and Transfer Statistical Evaluation of Dissolution Data in Method Validation and Transfer In the pharmaceutical industry, the validation of analytical methods is a critical component in ensuring the durability and reliability of drug products. Among these methods, dissolution testing plays a pivotal role in determining the release characteristics of a drug. Regulatory…
Automation and Online UV or HPLC Analysis in Dissolution Method Validation Automation and Online UV or HPLC Analysis in Dissolution Method Validation The development of automated dissolution systems enhances efficiency and accuracy in quality control laboratories across the pharmaceutical industry. Automated dissolution validation incorporating online UV or HPLC analysis is critical in complying with global regulatory standards. This guide provides…
Dissolution Method Validation for Poorly Soluble and BCS Class II Drugs Dissolution Method Validation for Poorly Soluble and BCS Class II Drugs Dissolution method validation is a critical aspect of pharmaceutical development, particularly for poorly soluble and BCS Class II drugs. This article aims to provide comprehensive guidance in accordance with regulatory expectations by the US FDA, EMA, ICH, and…
Dissolution Method Verification and Re-Validation After Post-Approval Changes Introduction to Validation in Pharmaceutical Development Pharmaceutical validation is a critical component of ensuring that the processes, equipment, and methods used in the manufacturing and testing of drugs consistently produce a product that meets predetermined quality criteria. Regulatory authorities like the FDA, EMA, and MHRA emphasize the importance of validation throughout the…
Regulatory Expectations for Dissolution Method Validation in ANDA Submissions Dissolution validation for ANDA (Abbreviated New Drug Application) submissions is a critical aspect of pharmaceutical manufacturing, particularly within the framework of regulatory compliance. Regulatory authorities, including the US FDA, EMA, and others, provide comprehensive guidelines on the validation of dissolution methods, ensuring that generic drugs demonstrate therapeutic equivalence to their branded…
Investigations of OOS Dissolution Results Linked to Weak Method Validation Investigations of OOS Dissolution Results Linked to Weak Method Validation In the pharmaceutical industry, the assurance of product quality is paramount, especially when it comes to analytical methods used in quality control (QC). Among these, the dissolution test is vital for ensuring that a drug product meets its specifications. However,…
Handling Surfactants and Complex Media in Dissolution Method Validation The validation of analytical methods in pharmaceutical development is critical for ensuring the quality and efficacy of drug products. One of the often-challenging aspects of this validation is the introduction of surfactants and complex media into dissolution testing. This article provides professionals in the pharmaceutical industry with a comprehensive step-by-step tutorial…
Dissolution Method Validation for Fixed-Dose Combination Products Dissolution Method Validation for Fixed-Dose Combination Products Introduction to Validation in Pharmaceutical Development The validation of analytical methods, particularly in the context of dissolution testing, plays a vital role in the pharmaceutical industry. The US FDA, EMA, and other regulatory authorities have established stringent guidelines to ensure that products are consistently manufactured to…
Lifecycle Management and Periodic Review of Dissolution and Release Methods The validation of analytical methods is a fundamental requirement for the pharmaceutical industry, ensuring that products are safe, effective and manufactured to the highest quality. In particular, the lifecycle management of dissolution and release testing methods plays a critical role in the overall validation process. This article provides a comprehensive…