Clinical trials are a vital part of the drug development process, helping determine the safety, efficacy, and long-term effects of new therapies. Yet, many questions surround how they work, who…
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The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new drug applications, new drug applications, and abbreviated new drug applications.
Few fields in clinical research are as dynamic and promising as ophthalmology. With the global population ageing and eye diseases becoming more prevalent, there is a growing demand for innovative treatments and therapies. This blog explores the emerging trends and updates that are shaping the ophthalmology clinical development landscape.
The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new drug applications, new drug applications, and abbreviated new drug applications.
FDA and Clinical Trials: Clinical trials stand as the cornerstone of pharmaceutical and biotech advancements, enabling new treatments and therapies to reach patients worldwide. At the helm of this transformative…
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