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Bioequivalence

Factors Affecting Bioequivalence (BE) Results
ByPharma Lesson February 8, 2025February 8, 2025 Reading Time: 3 minutes

Bioequivalence (BE) studies are crucial in the pharmaceutical industry to ensure that generic formulations exhibit comparable bioavailability to their reference products. Several factors influence BE results, potentially impacting regulatory approval and market entry. This review highlights the key determinants affecting BE outcomes, including formulation characteristics, physiological variability, study design, and analytical considerations. Formulation Factors The…

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Deviation

Deviations and Nonconformities in Pharmaceutical Industry
ByPharma Lesson February 2, 2025February 2, 2025 Reading Time: 2 minutes

“Deviation” terms used in the pharmaceutical industry, while the term “non-conformance” is classically used in the medical devices industry (ISO 13485:2016). Nonconformity Nonconformance means that there was an event with a process, service, or product, and the result does not match the requirements. ISO 9000:2015 defines nonconformity as “non-fulfilment of a requirement.” According to FDA…

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Process Validation

Process Validation Lifecycle Approach in Pharmaceutical Manufacturing
ByPharma Lesson February 2, 2025February 2, 2025 Reading Time: 2 minutes

The lifecycle approach to process validation has become the global standard, incorporated into guidelines by the US FDA, EU, and WHO (See TRS 1019, Annex 3, Appendix 7). Since WHO GMP guidelines apply to Bangladesh, this approach is equally relevant to our pharmaceutical industry. What does this mean for us? Process validation is no longer…

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Sterilization

Media Fill Process in Pharmaceutical Industry
ByPharma Lesson February 2, 2025February 2, 2025 Reading Time: 2 minutes

Is a process simulation testing, is a critical validation procedure in aseptic pharmaceutical manufacturing. It ensures the sterility of drug products by simulating the entire production process using sterile media in place of the actual product. The importance of media fill lies in its ability to verify that every step of the aseptic process maintains…

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Lyophilization

Lyophilization in Pharmaceutical Industry
ByPharma Lesson February 2, 2025February 3, 2025 Reading Time: 2 minutes

In the pharmaceutical industry, precision and innovation are everything. Among the many technologies shaping this field, the lyophilizer (freeze dryer) stands out as one of the most impactful. Lyophilization Lyophilization or freeze-drying removes water from a product by sublimation converting ice directly into vapor without passing through the liquid phase. It’s performed under low temperatures…

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Drug Delivery System | Pharmaceutical Development

Glass Transition Temperature and Drug Release from PLGA-Based Microspheres
ByPharma Lesson February 2, 2025February 2, 2025 Reading Time: 2 minutes

Poly(lactic-co-glycolic acid) (PLGA) is a widely used polymer in drug delivery systems, particularly for creating long-acting injectable microspheres. A crucial factor influencing the drug release profile of these formulations is the glass transition temperature (Tg), which represents the temperature at which PLGA transitions from a hard, glassy state to a softer, rubbery state. Impact of…

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