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Understanding how a drug will act in the body, including how it is absorbed, distributed, and eventually eliminated, is a crucial component of drug research. Well-planned ADME investigations are conducted in the early stages of clinicalresearch to generate this important data, which is needed for regulatory submissions.
The complexities in clinicalresearch in both Clinicalresearch for both biologics and small molecules involves complex processes that are crucial for demonstrating safety, efficacy, and quality before obtaining regulatory approval. Enhancing bioavailability is often a key focus in the development of small molecule drugs.
At Quotient Sciences, our drug development consultants use our 30+ years of experience in clinicalresearch outcomes to profile each new molecule that we look at. Quotient Sciences was asked to select the best candidate based on material science and oral bioavailability considerations.
However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. Oral Protein / Peptide-based Drugs.
XTALKS CLINICAL EDGE: Issue 3 — Interview with Marinus Pharmaceuticals’ Dr. Flatt Xtalks Clinical Edge is a magazine for clinicalresearch professionals and all who want to be informed about the latest trends and happenings in clinical trials.
Clinicalresearch experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Consider targeting your therapies that fail to be orally bioavailable and brain penetrant. The patients are waiting!
XTALKS CLINICAL EDGE: Issue 3 — Interview with BeiGene’s Dr. Mobasher Xtalks Clinical Edge is a magazine for clinicalresearch professionals and all who want to be informed about the latest trends and happenings in clinical trials.
Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).
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