Tag: Stability of Antibody-Based Drugs

SOP for Performing Real-Time Stability Testing for Drug Substances

SOP for Performing Real-Time Stability Testing for Drug Substances Standard Procedure for Conducting Real-Time Stability Testing on Drug Substances 1) Purpose The purpose of this SOP is to provide a structured procedure for conducting real-time stability testing of drug substances to ensure their safety, efficacy, and quality throughout their shelf life under recommended storage conditions….

Stability Studies SOP

How to Implement Stability Testing for High-Risk Drug Products under Regulatory Guidelines

How to Implement Stability Testing for High-Risk Drug Products under Regulatory Guidelines Stability Testing for High-Risk Drug Products: Regulatory Compliance Guide Introduction High-risk drug products, such as controlled substances, cytotoxic agents, and biologics, require stringent stability testing to ensure their safety, efficacy, and quality. Regulatory authorities, including the US FDA, EMA, and WHO, have established…

'How to' - Stability Studies

How to Conduct Stability Studies for Drugs with Narrow Therapeutic Index under US FDA Guidelines

How to Conduct Stability Studies for Drugs with Narrow Therapeutic Index under US FDA Guidelines Stability Studies for Drugs with Narrow Therapeutic Index: A Guide to US FDA Compliance Introduction Drugs with a narrow therapeutic index (NTI) have a small margin between therapeutic and toxic doses, making precise and rigorous stability testing essential to ensure…

'How to' - Stability Studies

How to Implement Stability Testing for Non-Oral Dosage Forms in Compliance with Regulatory Guidelines

How to Implement Stability Testing for Non-Oral Dosage Forms in Compliance with Regulatory Guidelines Ensuring Compliance in Stability Testing for Non-Oral Dosage Forms Introduction Non-oral dosage forms, such as injectables, inhalers, transdermal patches, and ophthalmic solutions, present unique challenges in stability testing due to their distinct formulations, delivery mechanisms, and storage conditions. Ensuring compliance with…

'How to' - Stability Studies

SOP for Designing a Stability Study Protocol for Drug Products

SOP for Designing a Stability Study Protocol for Drug Products Procedure for Creating a Stability Study Protocol for Drug Products 1) Purpose The purpose of this SOP is to outline the standardized procedure for designing a stability study protocol for drug products. The aim is to ensure that all stability studies are conducted consistently and…

Stability Studies SOP

How to Conduct Stability Testing for Biologics Under Biosimilar Regulatory Guidelines

How to Conduct Stability Testing for Biologics Under Biosimilar Regulatory Guidelines Stability Testing for Biologics: Adhering to Biosimilar Guidelines Introduction Biologics, including biosimilars, are complex molecules that require stringent stability testing to ensure their safety, efficacy, and quality. Stability studies for biosimilars must demonstrate that the product remains comparable to its reference biologic under specified…

'How to' - Stability Studies

How to Address Stability Testing for Breakthrough Therapy Drugs under FDA Guidelines

How to Address Stability Testing for Breakthrough Therapy Drugs under FDA Guidelines Stability Testing for Breakthrough Therapy Drugs: Navigating FDA Requirements Introduction Breakthrough therapy drugs are designated by the FDA for expedited development and review due to their potential to provide substantial improvement over existing therapies for serious conditions. These drugs require specific stability testing…

'How to' - Stability Studies

How to Implement ICH Q1A(R2) for Stability Testing of APIs and Drug Products

How to Implement ICH Q1A(R2) for Stability Testing of APIs and Drug Products Applying ICH Q1A(R2) Guidelines for Stability Testing of APIs and Drug Products Introduction Stability testing is a critical component of the drug development process, ensuring that Active Pharmaceutical Ingredients (APIs) and finished drug products maintain their intended quality, safety, and efficacy over…

'How to' - Stability Studies

SOP for Conducting Accelerated Stability Testing of Pharmaceuticals

SOP for Conducting Accelerated Stability Testing of Pharmaceuticals Guidelines for Conducting Accelerated Stability Studies on Pharmaceuticals 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting accelerated stability testing of pharmaceuticals. The objective is to determine the shelf life and expiration date of drug products by subjecting them to conditions…

Stability Studies SOP

How to Conduct Stability Studies for Complex Generic Drug Products as per US FDA Guidelines

How to Conduct Stability Studies for Complex Generic Drug Products as per US FDA Guidelines Conducting Stability Studies for Complex Generic Drugs: A US FDA Compliance Guide Introduction Complex generic drugs, which include formulations such as liposomal drugs, injectables, and transdermal systems, require rigorous stability studies to ensure their safety, efficacy, and quality throughout their…

'How to' - Stability Studies