Tag: Drug stability studies,

SOP for Conducting Stability Studies for Biologics

SOP for Conducting Stability Studies for Biologics Procedure for Performing Stability Studies for Biologic Drug Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on biologic drug products to evaluate their shelf life and storage conditions under various environmental factors such as temperature, humidity, and light….

Stability Studies SOP

How to Implement Stability Testing for Nanomedicines under Regulatory Guidelines

How to Implement Stability Testing for Nanomedicines under Regulatory Guidelines Stability Testing for Nanomedicines: Navigating Regulatory Requirements Introduction Nanomedicines, which utilize nanoscale materials to deliver therapeutic agents, pose unique challenges in stability testing due to their complex structures, surface properties, and interactions with biological systems. Regulatory authorities, including the US FDA, EMA, and WHO, have…

'How to' - Stability Studies

How to Conduct Stability Studies for Drug Products in Extreme Conditions per Regulatory Guidelines

How to Conduct Stability Studies for Drug Products in Extreme Conditions per Regulatory Guidelines Stability Testing for Drug Products in Extreme Conditions: Ensuring Regulatory Compliance Introduction Drug products intended for use in extreme conditions, such as high altitude, extreme temperatures, or high humidity, require specialized stability testing to ensure their safety, efficacy, and quality. Regulatory…

'How to' - Stability Studies

How to Apply ICH Q6A for Specification Setting in Stability Testing

How to Apply ICH Q6A for Specification Setting in Stability Testing Applying ICH Q6A for Specification Setting in Stability Studies Introduction ICH Q6A, “Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products,” provides guidelines for setting specifications that define the quality of a drug substance or product. Applying ICH Q6A…

'How to' - Stability Studies

SOP for Interpreting Stability Data for Regulatory Submissions

SOP for Interpreting Stability Data for Regulatory Submissions Guidelines for Interpreting Stability Data for Regulatory Submissions 1) Purpose The purpose of this SOP is to provide a standardized procedure for interpreting stability data to ensure it meets the requirements for regulatory submissions. The aim is to determine if the stability data supports the proposed shelf…

Stability Studies SOP

How to Conduct Stability Testing for Liposomal Drug Products under Regulatory Guidelines

How to Conduct Stability Testing for Liposomal Drug Products under Regulatory Guidelines Stability Testing for Liposomal Drug Products: A Regulatory Compliance Guide Introduction Liposomal drug products, which utilize lipid-based carriers to deliver active ingredients, require specific stability testing to ensure their safety, efficacy, and quality throughout their shelf life. These formulations present unique challenges due…

'How to' - Stability Studies

How to Implement Stability Testing for Drug Products in Compliance with Regional Regulatory Requirements

How to Implement Stability Testing for Drug Products in Compliance with Regional Regulatory Requirements Stability Testing for Drug Products: Navigating Regional Regulatory Requirements Introduction Drug products must meet specific stability requirements to ensure safety, efficacy, and quality across different regions. Various regulatory authorities, such as the US FDA, EMA, and other regional agencies, have distinct…

'How to' - Stability Studies

How to Conduct Stability Studies for Novel Excipient-Drug Combinations in Compliance with Regulatory Guidelines

How to Conduct Stability Studies for Novel Excipient-Drug Combinations in Compliance with Regulatory Guidelines Stability Testing for Novel Excipient-Drug Combinations: A Regulatory Guide Introduction Novel excipients are substances not previously used in approved drug products, often introduced to enhance formulation properties or delivery of the active drug. Stability testing for drug products containing novel excipient-drug…

'How to' - Stability Studies

SOP for Analyzing Stability Samples Using HPLC

SOP for Analyzing Stability Samples Using HPLC Procedure for Analyzing Stability Samples with High-Performance Liquid Chromatography (HPLC) 1) Purpose The purpose of this SOP is to provide a detailed procedure for analyzing stability samples using High-Performance Liquid Chromatography (HPLC) to determine the quality and stability of drug products over time. 2) Scope This SOP applies…

Stability Studies SOP

How to Address Stability Testing for Drug Products with Multiple Active Ingredients under Regulatory Guidelines

How to Address Stability Testing for Drug Products with Multiple Active Ingredients under Regulatory Guidelines Stability Testing for Drug Products with Multiple Active Ingredients: A Regulatory Guide Introduction Drug products with multiple active ingredients, such as combination therapies, require thorough stability testing to ensure that each ingredient remains stable and maintains its intended efficacy and…

'How to' - Stability Studies