‘How to’ – Stability Studies

How to Conduct Stability Testing for Drug Products Under ASEAN Guidelines Guidelines for Stability Testing of Drug Products in ASEAN Countries Introduction Stability testing is essential to ensure that drug products maintain their quality, safety, and efficacy throughout their shelf life. The Association of Southeast Asian Nations (ASEAN) has established specific guidelines for stability testing…

Read More “How to Conduct Stability Testing for Drug Products Under ASEAN Guidelines” »

How to Perform Stability Studies Following EMA (European Medicines Agency) Guidelines Conducting Stability Studies in Compliance with EMA Requirements Introduction Stability studies are a fundamental aspect of the pharmaceutical development process, ensuring that a product maintains its intended quality, safety, and efficacy throughout its shelf life. The European Medicines Agency (EMA) has established specific guidelines…

Read More “How to Perform Stability Studies Following EMA (European Medicines Agency) Guidelines” »

How to Report Stability Data in Common Technical Document (CTD) Format Reporting Stability Data in CTD Format: A Comprehensive Guide Introduction Stability data is a crucial component of regulatory submissions for pharmaceutical products, providing evidence of the product’s quality, safety, and efficacy over its shelf life. The Common Technical Document (CTD) format, developed by the…

Read More “How to Report Stability Data in Common Technical Document (CTD) Format” »

How to Conduct Bracketing and Matrixing Studies per ICH Q1D Implementing Bracketing and Matrixing Designs According to ICH Q1D Guidelines Introduction Bracketing and matrixing are two scientifically sound approaches that can be employed in stability testing to reduce the number of stability tests required while still ensuring product quality over time. The ICH Q1D guideline…

Read More “How to Conduct Bracketing and Matrixing Studies per ICH Q1D” »

How to Ensure Compliance with US FDA Stability Testing Requirements Achieving Compliance with US FDA Stability Testing Standards Introduction Stability testing is a critical requirement for ensuring that pharmaceutical products maintain their quality, safety, and efficacy throughout their shelf life. The US Food and Drug Administration (FDA) mandates specific stability testing guidelines under the Code…

Read More “How to Ensure Compliance with US FDA Stability Testing Requirements” »

How to Implement Stability Testing for Export Products According to ICH Q1F Guidelines for Conducting Stability Testing for Export Products per ICH Q1F Introduction Stability testing for pharmaceutical products intended for export is crucial to ensure that these products remain safe, effective, and of high quality under various climatic conditions. The ICH Q1F guidelines were…

Read More “How to Implement Stability Testing for Export Products According to ICH Q1F” »

How to Interpret ICH Q1B Photostability Testing Guidelines Understanding and Applying ICH Q1B Photostability Testing Standards Introduction Photostability testing is a critical aspect of the stability studies for pharmaceuticals, ensuring that drug substances and products remain stable when exposed to light. The ICH Q1B guidelines provide comprehensive instructions on how to conduct photostability testing to…

Read More “How to Interpret ICH Q1B Photostability Testing Guidelines” »

How to Conduct Stability Testing in Accordance with WHO Guidelines Conducting Stability Testing as per WHO Requirements Introduction Stability testing is an integral part of pharmaceutical product development, ensuring that the product maintains its safety, efficacy, and quality throughout its shelf life. The World Health Organization (WHO) provides comprehensive guidelines for conducting stability testing, which…

Read More “How to Conduct Stability Testing in Accordance with WHO Guidelines” »

How to Prepare Stability Data for US FDA Submissions Preparing Stability Data for Submissions to the US FDA Introduction Stability data is an essential component of the regulatory submission process for drug products in the United States. The US Food and Drug Administration (FDA) requires comprehensive stability data to ensure that drug products meet their…

Read More “How to Prepare Stability Data for US FDA Submissions” »

How to Design Stability Studies in Compliance with ICH Q1A(R2) Guidelines Designing Stability Studies in Line with ICH Q1A(R2) Regulations Introduction Stability studies are crucial in ensuring the safety, efficacy, and quality of pharmaceutical products throughout their shelf life. Designing these studies in compliance with the ICH Q1A(R2) guidelines is vital for regulatory approval and…

Read More “How to Design Stability Studies in Compliance with ICH Q1A(R2) Guidelines” »