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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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Clinical-Pharmacology-graph_Large-molecule_web

Alta Sciences

Clinical-Pharmacology-graph_Large-molecule_web ehdem Tue, 01/23/2024 - 14:06 Image Clinical-Pharmacology-graph_Large-molecule_web.png Weight 1

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PBSS - San Francisco Bay—Clinical Pharmacology Studies on Hepatic and Renal Impairments for NDA Filing

Alta Sciences

PBSS - San Francisco Bay—Clinical Pharmacology Studies on Hepatic and Renal Impairments for NDA Filing iianiro Tue, 10/29/2024 - 16:53 Image gettyimages-1330763893-640x640.jpg jpg Synopsis Foster City, CA URL [link] Event End Date Fri, 11/01/2024 - 12:00 Event Start Date Fri, 11/01/2024 - 12:00 Weight 1

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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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Clinical Pharmacology Considerations for Peptide Drug Products

thought leadership

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall somewhere between drugs and biologics and do not have the usually well-defined characteristics of either category.

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Translating complex data into actionable insights, to create big value for smaller biotech companies

BioPharma Drive: Drug Pricing

Why clinical pharmacology is critical to accelerating drug development, and how it can help drive value in a complex and rapidly evolving landscape.

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Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services

Alta Sciences

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation , manufacturing, and analytical services.