Tag: Stability indicating methods

Designing Stability Programs for Emerging Market Compliance

Designing Stability Programs for Emerging Market Compliance Step-by-Step Guide to Designing Stability Programs for Emerging Market Compliance Introduction Pharmaceutical companies aiming to expand into emerging markets face unique regulatory and environmental challenges. Stability testing programs must be tailored to meet the specific requirements of each target region while addressing climatic conditions, infrastructure constraints, and regulatory…

Regulatory Guidelines

Factors Influencing Accelerated Testing Conditions for Biologics

Factors Influencing Accelerated Testing Conditions for Biologics Expert Insights into Accelerated Testing Conditions for Biologics Introduction to Accelerated Testing for Biologics Biologics, such as monoclonal antibodies, vaccines, and recombinant proteins, are highly sensitive therapeutic products that require meticulous stability testing. Accelerated testing plays a critical role in assessing their stability under stress conditions, providing valuable…

Types of Stability Studies

Real-Time Testing for Controlled-Release Dosage Forms: Unique Challenges

Real-Time Testing for Controlled-Release Dosage Forms: Unique Challenges Understanding the Unique Challenges in Real-Time Testing for Controlled-Release Dosage Forms Introduction to Real-Time Testing for Controlled-Release Dosage Forms Controlled-release dosage forms are designed to deliver active pharmaceutical ingredients (APIs) over an extended period, improving therapeutic outcomes and enhancing patient compliance. However, the complexity of their formulation…

Types of Stability Studies

ASEAN Guidelines for Shelf-Life Studies in Health Supplements

ASEAN Guidelines for Shelf-Life Studies in Health Supplements Comprehensive Guide to ASEAN Shelf-Life Guidelines for Health Supplements Introduction The ASEAN guidelines for shelf-life studies in health supplements provide a standardized framework for ensuring product quality, safety, and efficacy. With the growing demand for health supplements in the ASEAN region, these guidelines aim to harmonize regulatory…

Regulatory Guidelines

Bridging Stability Testing and Product Design for Better Efficacy

Bridging Stability Testing and Product Design for Better Efficacy Expert Guide to Aligning Stability Testing and Product Design Introduction to Stability Testing and Product Design The interplay between stability testing and product design is a cornerstone of pharmaceutical development. By integrating stability considerations into product design, manufacturers can enhance the efficacy, safety, and shelf life…

Types of Stability Studies

How to Perform Accelerated Testing for Shelf-Life Predictions

How to Perform Accelerated Testing for Shelf-Life Predictions A Step-by-Step Guide to Accelerated Testing for Shelf-Life Predictions Introduction to Accelerated Testing Accelerated testing is a vital component of stability studies, allowing pharmaceutical manufacturers to predict the shelf life of drug products in a shorter time frame. By exposing products to elevated temperature, humidity, and other…

Types of Stability Studies

Navigating Differences Between EMA and FDA Stability Guidelines

Navigating Differences Between EMA and FDA Stability Guidelines Practical Tips for Navigating EMA and FDA Stability Guidelines Introduction The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are two of the most influential regulatory agencies in the pharmaceutical industry. While both align with ICH Q1A(R2) guidelines, each agency has specific requirements…

Regulatory Guidelines

Designing Stability Testing Protocols for OTC Drug Products

Designing Stability Testing Protocols for OTC Drug Products A Step-by-Step Guide to Stability Testing Protocols for OTC Drug Products Introduction to Stability Testing for OTC Drug Products Over-the-counter (OTC) drug products are widely used for self-medication, offering convenience and accessibility. However, their safety and efficacy depend on robust stability testing protocols that ensure product quality…

Types of Stability Studies

Regulatory Requirements for Accelerated Stability Testing

Regulatory Requirements for Accelerated Stability Testing A Step-by-Step Guide to Regulatory Requirements for Accelerated Stability Testing Introduction Accelerated stability testing is a cornerstone of pharmaceutical development, enabling manufacturers to predict a product’s shelf life in a shorter timeframe. Regulatory agencies such as the FDA, EMA, and WHO provide comprehensive guidelines for conducting these studies under…

Regulatory Guidelines

Freeze-Thaw Stability Studies for Parenteral Dosage Forms

Freeze-Thaw Stability Studies for Parenteral Dosage Forms Expert Guide to Freeze-Thaw Stability Studies for Parenteral Dosage Forms Introduction to Freeze-Thaw Stability Studies Parenteral dosage forms, including injectables and biologics, are highly sensitive to environmental conditions during manufacturing, storage, and transportation. Freeze-thaw stability studies are critical in evaluating how these products withstand repeated freezing and thawing…

Types of Stability Studies