amsbiowp, Author at AMSbiopharma

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. As drug candidates move from early research through commercial production, robust pharma quality control strategies become the backbone of safe, effective, and…

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 safety, efficacy, and pharmacological profile. This process begins with preclinical research, a critical phase in the drug development process that bridges the…

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 reliable, reproducible, and scientifically sound data. The ICH guidelines method validation framework, updated through ICH Q2(R2) and the complementary Q14 guideline on…

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 regulatory authorities such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have established frameworks to…

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 trials. Through a combination of in vitro, in silico, in chimico, and/or in vivo studies, researchers assess the pharmacological activity, safety, and…

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 deeper understanding of disease mechanisms, and an increasing demand for targeted therapies with fewer side effects. These treatments, developed from living organisms,…

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 Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed various guidelines, with the upcoming ICH Q3E guideline…

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 scientific consensus documents. The ICH guidelines full form stands for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human…

Advanced Analytical Methods in Detecting Impurities in OZEMPIC

Ozempic Impurities Explained: Ensuring Purity and Safety in Semaglutide-Based Therapies

Semaglutide has emerged as a groundbreaking therapy for managing type 2 diabetes, marketed under brand names like Ozempic. As a glucagon-like peptide-1 (GLP-1) receptor agonist, it significantly benefits glucose regulation and weight management. Its patent is set to expire…

Pharma Quality Control Strategies for Drug Development and Regulatory Compliance

Preclinical Research in Drug Development: From Toxicology to Translational Insights

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

ICH Q3 Impurity Guidelines: Analytical Strategies for Safer Drug Development

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

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

ICH Q3E Guideline: Impurities Assessment and Control

ICH Guidelines: Drug Stability Testing Essentials

Ozempic Impurities Explained: Ensuring Purity and Safety in Semaglutide-Based Therapies

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