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Introduction: In-process monitoring is a critical component of ensuring the quality and reliability of BA/BE studies, especially those involving drug-drug
Abstract For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of
Introduction In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the
Introduction There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy,
Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals
Introduction Liposomal Amphotericin-B is a critical antifungal medication that requires careful attention during Bioequivalence (BE) studies. These studies aim to
