Tag: Drug stability studies,

How to Address Stability Testing Requirements for Investigational New Drug (IND) Applications

How to Address Stability Testing Requirements for Investigational New Drug (IND) Applications Meeting Stability Testing Requirements for IND Applications: A Detailed Guide Introduction Stability testing is a crucial component of Investigational New Drug (IND) applications, ensuring that investigational products remain safe and effective throughout clinical trials. Understanding and meeting the stability testing requirements set by…

'How to' - Stability Studies

How to Conduct Stability Studies for Topical Products in Compliance with US FDA and EMA Guidelines

How to Conduct Stability Studies for Topical Products in Compliance with US FDA and EMA Guidelines Conducting Stability Studies for Topical Products: US FDA and EMA Compliance Introduction Topical products, such as creams, ointments, and lotions, require specific stability studies to ensure their safety and efficacy over time. Compliance with US FDA and EMA guidelines…

'How to' - Stability Studies

How to Implement ICH Q9 for Risk Management in Stability Testing

How to Implement ICH Q9 for Risk Management in Stability Testing Applying ICH Q9 Principles for Effective Risk Management in Stability Testing Introduction ICH Q9 provides a systematic approach to risk management in the pharmaceutical industry, including stability testing. Effective implementation of ICH Q9 ensures that risks associated with stability testing are identified, evaluated, and…

'How to' - Stability Studies

How to Conduct Stability Studies for Fixed-Dose Combination Products under Regulatory Guidelines

How to Conduct Stability Studies for Fixed-Dose Combination Products under Regulatory Guidelines Conducting Stability Studies for Fixed-Dose Combination Drugs: A Regulatory Approach Introduction Fixed-dose combination (FDC) products combine two or more active pharmaceutical ingredients (APIs) in a single dosage form. Conducting stability studies for these products is crucial to ensure their safety, efficacy, and quality…

'How to' - Stability Studies

How to Ensure Compliance with Global Stability Testing Requirements (US FDA, EMA, WHO)

How to Ensure Compliance with Global Stability Testing Requirements (US FDA, EMA, WHO) Ensuring Compliance with International Stability Testing Standards: A Comprehensive Guide Introduction Stability testing is a critical aspect of pharmaceutical development and quality assurance. Ensuring compliance with global stability testing requirements is essential for the approval, distribution, and maintenance of drug products in…

'How to' - Stability Studies

Guide to Conducting Stability Studies on Pharmaceutical Dosage Forms

Follow these instructions to conduct stability studies effectively on various pharmaceutical dosage forms: General Considerations: For each dosage form: Evaluate appearance, assay, and degradation products. Limit degradation product testing for generic products to compendial requirements. Note: The listed tests are not exhaustive. Not every test needs to be included in the stability protocol. Consider safety…

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Stability Studies for Drugs with Low Solubility

Drugs with low solubility present unique challenges in stability studies due to their limited aqueous solubility, which can affect dissolution, bioavailability, and stability under various storage conditions. Conducting stability studies for such drugs requires careful consideration of formulation strategies, analytical methods, and regulatory requirements to ensure accurate assessment of product stability and shelf life. Key…

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Regulatory requirements for stability studies

Regulatory Requirements for Stability Studies in Different Regions Stability studies are an integral part of the drug development process, ensuring the safety, efficacy, and quality of pharmaceutical products throughout their shelf life. Regulatory agencies in different regions, including the United States, Europe, and other countries, have established guidelines and requirements for conducting stability studies to…

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Stability Studies for Peptides and Proteins

Peptides and proteins are biopharmaceuticals with complex structures and delicate chemical properties. Stability studies for peptides and proteins are crucial for assessing their physical, chemical, and biological stability under various storage conditions. These studies provide valuable insights into the degradation pathways, formulation optimization, and shelf-life determination of peptide and protein-based therapeutics. Key Considerations When conducting…

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Conducting stability studies for complex dosage Forms

Considerations for Stability Studies of Complex Dosage Forms Complex dosage forms, such as extended-release formulations, liposomal formulations, and combination products, present unique challenges in stability studies due to their intricate compositions, varied release mechanisms, and susceptibility to degradation. Conducting stability studies for complex dosage forms requires careful consideration of formulation characteristics, manufacturing processes, and regulatory…

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