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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound. How does bioavailability play a role in biopharmaceutics? Now fraction absorbed and bioavailability are often confused and used interchangeably.

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CDER’s Office of Compliance Kicks Off Annual Report Season with Rundown of 2023’s Major Public Health Enforcement Initiatives

The FDA Law Blog

Some takeaways on those efforts that we gleaned from the report: Compounding. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Communication in this area included on-line videos, webinars, summits, conferences, and international outreach. Drug Supply Chain. Clinical Trials.

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How Process Simulation Enhances Tech Transfer and Regulatory Submissions in the Biopharma Product Lifecycle

ISPE

1 More recently, regulators like the FDA have increasingly promoted the benefits of modeling (e.g., For a more in-depth review of these topics, including Q&A, register for the ISPE webinar “Advance Biopharma Tech Transfer Using Process Modeling & Simulation”, on Thursday, 4 May 2023 at 1000 ET. Register Now!

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This on-demand webinar discusses the importance of a patient-appropriate BL & GF profile. Please check your email to download the Webinar.

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Patient Engagement in Pharma – Why and How?

Viseven

For instance, the FDA’s requirement for Patient Perspectives in drug reviews has made patient engagement crucial for approvals and reimbursements. This education can be delivered through various formats, such as webinars, videos, and written materials.