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Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval?

Fierce BioTech

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? Eva Gil Berglund, PhD Justin Hay, PhD Paola Coppola, MSc Duration 60 Minutes Clinical pharmacology information comprises more than 50% of a drug label. Click here to login. Listing Image Certara-LogoListing-12052023.png

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Optimized 505(b)(1) and 505(b)(2) Clinical Pharmacology Programs to Accelerate Drug Development

The Premier Consulting Blog

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. food effect, smoking, and drug-drug interactions) on drug exposure and response.

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

Translational and Clinical Pharmacology [Internet]. Model‐Informed Therapeutic Dose Optimization Strategies for Antibody–Drug Conjugates in Oncology: What Can We Learn From US Food and Drug Administration–Approved Antibody–Drug Conjugates? Clinical Pharmacology & Therapeutics. 2022 [cited 2023 Feb 10];30(2):71.

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Shaping drug development success: how does artwork play a role?

Drug Target Review

Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information. Developing a company core data sheet (CCDS) and reference safety information (RSI) document within preclinical stages can also help guide later, critical labelling decisions.

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New strategy for COVID-19 prophylaxis?

The Pharma Data

Dr. Gunther Hartmann from the Institute of Clinical Chemistry and Clinical Pharmacology at the University Hospital Bonn, in cooperation with other members of the cluster of excellence ImmunoSensation2 at the University of Bonn, have shown this in mice. Researchers led by Prof. SARS-CoV-2 belongs to the genus Betacoronavirus.

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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law Blog: Drug Discovery

Next Steps for the Hub and Beyond The FDA plans on holding an open public meeting this Fall, including a docket for public comment, to provide further information about the Agency’s vision for the Hub and receive feedback from the community to help shape the Hub’s priorities and initiatives.

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Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.