Challenges and Expert Monitoring in Liposomal Amphotericin-B BE Studies Introduction Liposomal Amphotericin-B is a critical antifungal medication that requires careful attention during Bioequivalence (BE) studies. These studies aim to demonstrate the similarity of a generic liposomal Amphotericin B formulation to the reference drug in terms of pharmacokinetics. Zenovel, with its extensive experience in monitoring Amphotericin… Continue reading Optimizing Liposomal Amphotericin-B BE Studies
Category: GCP
Enhancing Clinical Studies with GCP Audit and Monitoring
Enhancing Clinical Studies with GCP Audit and Monitoring Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance… Continue reading Enhancing Clinical Studies with GCP Audit and Monitoring
GCP Compliance in Clinical Research
GCP Compliance in Clinical Research We all know very well what GCP truly means in clinical research accurate and credible data plus rights, Integrity, and confidentiality of trial subjects. i.e., “Quality Data + Ethics= GCP” So, what GCP should lead………………” Patient rights, Safety, and Well-being” We certainly always talk about GCP compliance during… Continue reading GCP Compliance in Clinical Research
Importance and Purpose of Clinical Research Monitoring
Introduction: There is no doubt that medical science is reaching new heights every day. All processes related to FDA approval are becoming more advanced, systematic, and quick. The same is true for clinical trial monitoring – a critical activity in drug development and marketing approval to ensure the quality of the research data and the protection of… Continue reading Importance and Purpose of Clinical Research Monitoring