Author: digi

SOP for Performing Stability Studies in Line with ICH Guidelines

SOP for Performing Stability Studies in Line with ICH Guidelines Procedure for Conducting Stability Studies According to ICH Guidelines 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies in accordance with the International Council for Harmonisation (ICH) guidelines to ensure global regulatory compliance for drug substances and…

Stability Studies SOP

How to Conduct Stability Studies for Orphan Drugs

How to Conduct Stability Studies for Orphan Drugs Stability Testing Strategies for Rare Disease Medications Introduction Orphan drugs, designed to treat rare diseases, often face unique challenges in development due to their limited patient populations and specialized formulations. Stability studies for orphan drugs are critical to ensure their safety and efficacy over time, particularly as…

'How to' - Stability Studies

How to Perform Stability Studies for Highly Potent Drugs

How to Perform Stability Studies for Highly Potent Drugs Stability Testing Guidelines for Potent Pharmaceutical Products Introduction Highly potent drugs, such as those used in oncology or hormone therapies, require special considerations during stability testing due to their strength and potential toxicity. Ensuring the stability of these drugs is crucial to maintaining their efficacy and…

'How to' - Stability Studies

How to Conduct Stability Studies for Ready-to-Use IV Bags

How to Conduct Stability Studies for Ready-to-Use IV Bags Stability Testing Guidelines for IV Bag Formulations Introduction Ready-to-use IV bags are essential for delivering intravenous medications in a convenient and controlled manner. However, the combination of drug and infusion bag presents unique stability challenges that must be addressed to ensure product safety and efficacy. Stability…

'How to' - Stability Studies

SOP for Assessing the Stability of Fixed-Dose Combinations

SOP for Assessing the Stability of Fixed-Dose Combinations Procedure for Conducting Stability Studies on Fixed-Dose Combination Products 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on fixed-dose combination (FDC) products to evaluate their shelf life, safety, and efficacy under various environmental conditions such as temperature, humidity,…

Stability Studies SOP

How to Assess the Impact of Storage Conditions on Drug Products

How to Assess the Impact of Storage Conditions on Drug Products Evaluating Drug Stability Under Various Storage Conditions Introduction Storage conditions can significantly affect the stability of drug products, potentially leading to changes in their efficacy, safety, and shelf life. Factors such as temperature, humidity, and light exposure can cause physical and chemical degradation, making…

'How to' - Stability Studies

How to Conduct Stability Studies for Drugs in Pre-Filled Syringes

How to Conduct Stability Studies for Drugs in Pre-Filled Syringes Stability Testing Guidelines for Pre-Filled Syringe Products Introduction Pre-filled syringes offer convenience and accuracy in drug administration, making them increasingly popular in pharmaceutical packaging. However, the combination of drug and device presents unique stability challenges that must be addressed to ensure product safety and efficacy….

'How to' - Stability Studies

How to Evaluate Stability for Drugs in Clinical Trials

How to Evaluate Stability for Drugs in Clinical Trials Stability Testing Guidelines for Investigational Drugs Introduction Stability testing during clinical trials is essential for ensuring that investigational drugs maintain their safety and efficacy throughout the trial period. As these drugs are often in the early stages of development, stability studies must be carefully designed to…

'How to' - Stability Studies

SOP for Conducting Stability Studies for Transdermal Patches

SOP for Conducting Stability Studies for Transdermal Patches Procedure for Conducting Stability Studies on Transdermal Patches 1) Purpose The purpose of this SOP is to provide a standardized procedure for conducting stability studies on transdermal patches to evaluate their shelf life, adhesion properties, and drug release profile under various environmental conditions such as temperature, humidity,…

Stability Studies SOP

How to Perform Stability Studies for Hormonal Products

How to Perform Stability Studies for Hormonal Products Guidelines for Stability Testing of Hormonal Products Introduction Hormonal products, including steroids, thyroid hormones, and reproductive hormones, play a crucial role in treating various medical conditions. These products are often sensitive to environmental factors, such as temperature and light, which can affect their potency and efficacy. Conducting…

'How to' - Stability Studies