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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.

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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. Click here to login.

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

Drug Target Review

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.

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Altasciences Supports Metsera in Their Early-Stage Clinical Trials for Obesity

Alta Sciences

In addition to clinical conduct, Altasciences supported Metsera with its proactive drug development solution , including nonclinical, bioanalysis, CRO and program management services for several additional therapeutic candidates. This work enabled Metsera to recently initiate a randomized 16-week Phase II trial of MET-097i.

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

Alta Sciences

Altasciences’ Commitment to Supporting Pharma and Biotech With Comprehensive Bioanalytical Services pmjackson Wed, 11/13/2024 - 14:50 Greater Montréal, Québec, 11/13, 2024 — Altasciences , a trusted drug development research partner for over 30 years, continues its commitment to providing world-class bioanalytical services.

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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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TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY

Alta Sciences

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY aasimakopoulos Mon, 05/15/2023 - 16:06 Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion , without, for the most part, shorter development timelines.