Author: digi

Use of Simulated Sunlight in Photostability Chambers

Use of Simulated Sunlight in Photostability Chambers Harnessing Simulated Sunlight in Photostability Chambers for Drug Stability Testing Photostability testing is a regulatory requirement for drug development, mandated under ICH Q1B guidelines. This process ensures that light exposure does not compromise the safety, efficacy, or quality of pharmaceutical products. To replicate real-world light conditions, photostability chambers…

Photostability and Oxidative Stability Studies, Stability Testing Types

Real-Time and Accelerated Stability Studies for Biologics

Real-Time and Accelerated Stability Studies for Biologics Comprehensive Guide to Real-Time and Accelerated Stability Studies for Biologics Introduction Biologics, including monoclonal antibodies, recombinant proteins, vaccines, and biosimilars, are among the most complex and sensitive pharmaceuticals. Ensuring their stability over time is essential for regulatory approval, therapeutic efficacy, and patient safety. Real-time and accelerated Stability Studies…

Biopharmaceutical Stability, Real-Time and Accelerated Stability Studies for Biologics

Handling Discrepancies Between Accelerated and Long-Term Stability Data

Handling Discrepancies Between Accelerated and Long-Term Stability Data Expert Guide to Handling Discrepancies Between Accelerated and Long-Term Stability Data Stability testing is the cornerstone of pharmaceutical product lifecycle management. Typically, both accelerated (e.g., 40°C/75% RH) and long-term (e.g., 25°C/60% RH or 30°C/75% RH) studies are conducted to assess the degradation behavior of drug substances and…

Intermediate and Long-Term Stability Testing, Stability Testing Types

Using Stability Data for Expedited Global Regulatory Filings

Using Stability Data for Expedited Global Regulatory Filings Leveraging Stability Data for Expedited Global Pharmaceutical Filings Global health crises, unmet medical needs, and evolving regulatory landscapes have amplified the demand for expedited drug development and approval processes. Stability data, both real-time and accelerated, plays a crucial role in supporting these fast-track submissions across multiple regulatory…

Real-Time and Accelerated Stability Studies, Stability Testing Types

Surfactants in Biologics: Enhancing Product Stability

Surfactants in Biologics: Enhancing Product Stability How Surfactants Improve the Stability of Biologic Drug Products Maintaining the stability of biologic drugs is essential to ensure therapeutic effectiveness and regulatory compliance. As biopharmaceuticals are prone to denaturation, aggregation, and degradation under stress, surfactants have become indispensable excipients in modern biologic formulation. This guide explores how surfactants…

Stability Testing for Biopharmaceuticals, Stability Testing Types

Use of Simulated Sunlight in Photostability Chambers

Use of Simulated Sunlight in Photostability Chambers Simulating Sunlight in Photostability Chambers: Techniques and Regulatory Compliance for Drug Stability Testing Photostability testing is an essential part of pharmaceutical product development and registration, as mandated by ICH Q1B. One of the core components of this testing involves exposure to light sources that simulate natural sunlight. Simulated…

Photostability and Oxidative Stability Studies, Stability Testing Types

Stability Testing Report Generation and Documentation in Pharmaceuticals

Stability Testing Report Generation and Documentation in Pharmaceuticals Stability Testing Report Generation and Documentation in Pharmaceuticals Introduction Stability testing is a critical component of pharmaceutical development and regulatory submissions. However, the value of any stability study lies not just in the data generated, but in the quality and completeness of the report that summarizes it….

Protocols and Reports, Stability Testing Report Generation and Documentation

Use of Real-Time Temperature Loggers in Freeze-Thaw Studies

Use of Real-Time Temperature Loggers in Freeze-Thaw Studies How Real-Time Temperature Loggers Enhance Freeze-Thaw Stability Studies in Pharmaceuticals In pharmaceutical stability testing, particularly freeze-thaw and thermal cycling studies, maintaining precise temperature control is critical. Deviations can compromise data integrity, product quality, and regulatory compliance. Real-time temperature loggers have become indispensable tools for capturing accurate thermal…

Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

Use of Simulated Sunlight in Photostability Chambers

Use of Simulated Sunlight in Photostability Chambers Simulated Sunlight in Photostability Chambers: Applications in Pharmaceutical Stability Testing Photostability testing is a regulatory requirement under ICH Q1B to evaluate the effects of light exposure on drug substances and products. The use of simulated sunlight in photostability chambers is critical to reproduce real-world light conditions in a…

Photostability and Oxidative Stability Studies, Stability Testing Types

Climatic Zone-Based Long-Term Study Design for Stability Testing

Climatic Zone-Based Long-Term Study Design for Stability Testing Designing Long-Term Stability Studies Based on Climatic Zones: A Global Strategy Pharmaceutical products are distributed across a wide range of geographical regions, each with unique environmental conditions. Long-term stability studies must reflect these regional differences to ensure that drug quality is maintained throughout the product’s lifecycle. Climatic…

Intermediate and Long-Term Stability Testing, Stability Testing Types