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The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new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.
In the dynamic landscape of biotech and pharma, the role of a full-service CRO is more crucial than ever. CROs serve as invaluable partners for biotech and pharma, offering comprehensive…
Before delving into clinical trials, it's crucial to understand that while preclinical research lays the foundation by answering basic questions about a drug's safety, clinical research takes the investigation further…
The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new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.
Clinical trials are essential to advancing medical research and improving healthcare. Understanding the basics of clinical trials helps demystify the process and highlights their importance. This guide covers the key…
