Cloudbyz
MARCH 5, 2024
The complexities in clinical research in both Clinical research 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.
Roots Analysis
MARCH 2, 2022
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.
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The Pharma Data
MARCH 11, 2021
Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial. Session Type: Clinical Trials Plenary Session.
XTalks
AUGUST 30, 2022
Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. In a recent webinar, Dr. Vornov described the history and current progress in targeted CNS therapeutic delivery.
Drug Discovery World
JULY 25, 2023
Ethical considerations Given the vulnerable status of children, safeguards are needed when including a paediatric population in clinical investigations of drugs and medical devices. The guidance is for pharmaceutical companies conducting paediatric clinical trials in the EU using the PIP procedure.
Pharmaceutical Technology
NOVEMBER 24, 2022
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 clinical research to generate this important data, which is needed for regulatory submissions.
Pharmaceutical Technology
FEBRUARY 13, 2023
At Quotient Sciences, our drug development consultants use our 30+ years of experience in clinical research 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.
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