Remove Resources Drug-delivery-formulation
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Roche subcutaneous cancer immunotherapy granted MHRA approval

European Pharmaceutical Review

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. The safety and efficacy profile was consistent with the IV formulation.

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Formulation Strategies for Large Molecule Drug Products

Syner-G

Large molecule drug products produce highly effective medicines, but formulation can be challenging because of their complexity, sensitivity, and potential for instability. It is crucial that formulation strategies ensure their bioavailability and efficacy to develop new and successful products.

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Ensuring Product Safety: U.S. FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

Quality Matters

FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Disclaimer: The article below includes a discussion of key points of the guidance document. The guidance requires complying with the identity standards for a drug, including drug components, with a name recognized in USP-NF.

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Bridging Discovery and Delivery: The Essential Role of INDs in Biopharmaceutical Development

Syner-G

The IND Filing Process and Categories Federal law mandates that drugs have an approved marketing application for interstate transport, but developers of new drugs must distribute their potential products nationwide in order to conduct clinical trials, and so must request an exemption through an Investigational New Drug (IND) application.

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Thinking differently about excipient quality to ensure medicines supply chain resilience

Quality Matters

Despite being called “inactive” ingredients, excipients in medicines play a vital role in drug development, delivery, effectiveness, and stability. Comprising up to 90% of individual drug products, excipients function as binders, disintegrants, solubilizers, coatings, preservatives, colors, and flavorings.

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Consumer health innovation – where passion and science meet

pharmaphorum

After making her way from early-stage drug development research to her current role, Heather got straight to work on creating sustainable collaborations that made life better for people and their families. “I I am fascinated by the breadth of my role, which encompasses self-care products, skin health, sustainability and much more.

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5 Qualities to Look for in Your Veterinary Pharmacy Partners

epicur

Traditional 503A compounding pharmacies and 503B outsourcing manufacturers both serve as important partners for veterinary practices, providing patient-specific prescriptions and manufacturing bulk drugs for in-practice use and dispensing when allowed by state regulations. Do they provide options for easy ordering and fast delivery?