Newsletter | May 31, 2024

05.31.24 -- New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies

FEATURED EDITORIAL

New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies

The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends either June 3 or July 3, depending on which FDA webpage you’re looking at.

New Initiative Seeks To Back Up ICH's Harmonization Mission

An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.

INDUSTRY INSIGHTS

Understanding Quality Agreements Between You And Your Service Provider

An effective quality agreement communicates the responsibilities of each party in a clear, concise manner, allowing the reader to quickly and accurately determine to whom a specific responsibility is assigned. 

Particle Size Control Through Micronization: Challenges And Solutions

What technical issues need to be addressed if an API is to be successfully micronized? Explore a robust process development strategy that ensures all attributes critical for quality are maintained.

The Write Side Of AI: Helping Hands, Not Replacement Plans

AI applications in medical writing are in their infancy, and the technology suffers several hurdles including plagiarism, copyright infringement, and misinformation dissemination.

Emerging Trends And Opportunities In Orally Inhaled Drug Products

From targeting niche diseases to delivering cutting-edge medications, inhaled therapies are poised to become a cornerstone of modern medicine. Explore the intricacies of inhaled drug delivery.

SOLUTIONS

Drug Substance Or API Manufacturing

Our network can support discovery, preclinical, clinical and commercial programs for NCEs. Review our network's API capabilities below and contact us to simplify your outsourcing solutions.

Package Design Development Services

Our pharmaceutical packaging design department provides insightful packaging design and practical knowledge to deliver differentiated and cost-effective packaging solutions.

Custom Chemical Synthesis

Leverage our technical expertise as well as our comprehensive facilities and equipment for robust support of your project's chemical synthesis requirements.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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