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Quality Control and Regulatory Compliance

Pharma Quality Control Strategies for Drug Development and Regulatory Compliance

In pharmaceutical development, ensuring that products consistently meet predefined standards of identity, strength, purity, and quality it’s essential....
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Preclinical Research in Drug Development

Preclinical Research in Drug Development: From Toxicology to Translational Insights

Before a new compound can be administered to humans, it must undergo a rigorous process to ensure its...
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The analytical method of ICH guidelines

ICH Guidelines for Analytical Method Validation: Principles, Requirements and Industry Applications

In pharmaceutical development, validating analytical methods goes further than regulatory formality. It is a critical component of ensuring...
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Detail of ICH Q3 Impurity Guidelines

ICH Q3 Impurity Guidelines: Analytical Strategies for Safer Drug Development

Impurities in pharmaceuticals can compromise the safety, efficacy, and stability of a product. To safeguard public health, global...
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Analytical method and analythical priorities

Analytical Priorities in Drug Development: How Preclinical Data Shapes Regulatory Success

The preclinical research phase in the drug development process involves the extensive evaluation of candidate compounds before clinical...
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Quality control in biotechnology: ensuring GMP compliance in the biologics manufacturing process with HPLC

Quality Control in Biotechnology: Ensuring Safety in the Biologics Manufacturing Process

The use of biologics has grown exponentially in the last decade, driven by advances in genetic engineering, a...
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ICH Q3E Guideline: Impurities Assessment and Control

ICH Q3E Guideline: Impurities Assessment and Control

The safety and efficacy of pharmaceutical products largely depend on controlling impurities in their formulations. Therefore, the International...
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the ICH guidelines for drug stability testing explained

ICH Guidelines: Drug Stability Testing Essentials

What Are ICH Guidelines? The ICH, a non-profit international organization founded in 1990, developed the ICH guidelines as...
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