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The New Frontier in Drug Development: Understanding Biologics and Small Molecules

Cloudbyz

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.

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Oral Protein / Peptide-based Drugs: Addressing Key Unmet Needs Across Disease Indications

Roots Analysis

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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Lilly Announces Details of Presentations at 2021 American Association for Cancer Research (AACR)

The Pharma Data

Session Category: Clinical Research (Excluding Trials). Session Title: Disease-Oriented Innovative Clinical Research and Trials. Session Type: Clinical Trials Minisymposium. Abstract Number: 442. Session Title: Combination Immunotherapies. Session Type: E-Poster Session. Sintilimab. Abstract Number: CT041.

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What recent paediatric guidelines mean for drug developers 

Drug Discovery World

The final section provides practical and pragmatic approaches to clinical study design in paediatric patients including important considerations regarding dose formulation and selection, sample size, sample collection and analysis, relative bioavailability, food interactions and drug-drug interactions (DDIs), amongst others.

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Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Pharmaceutical Technology

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.

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Strategies for Streamlining Small Molecule Formulation Development When Bridging from Candidate Selection to First-in-Human Clinical Testing

Pharmaceutical Technology

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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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

Clinical research 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!

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