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FDA Releases Draft Guidance on Essential Drug Delivery Outputs

FDA Law Blog

FDA recently released a much-anticipated draft guidance to address these frequent questions: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.

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Intranasal Therapeutics and Drug Delivery Systems: The Perfect Alternative to Conventional Route of Administration

Roots Analysis

Interestingly, over the past few years, drug developers focused on non-respiratory diseases have also shifted their attention towards intranasal drug formulations. This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration.

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Oral Protein / Peptide-based Drugs: Addressing Key Unmet Needs Across Disease Indications

Roots Analysis

However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. Oral Protein / Peptide-based Drugs. Web: [link].

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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

In 2021, 72% of newly approved drugs were small molecules, and almost 50% of new drugs approved were OSD. While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry.

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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Some methods of direct CNS administration include intrathecal, intraparenchymal and intracerebroventricular (ICV) delivery.

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Breaking the Waves: How Blue Ocean Strategy in Healthcare Can Propel Pharma / Biotech Companies to Success

Roots Analysis

By charting new waters and creating uncontested market spaces, companies can differentiate themselves and unlock unprecedented growth opportunities. In this blog post, I’ll explore how pharma / biotech companies can leverage the blue ocean and red ocean strategy to make waves in the market.

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XPhyto Announces Drug Formulation Strategy and 2021 Milestones Innovation to Impact

The Pharma Data

The addition of in-house, scalable commercial drug manufacturing capability is expected to add significant value and optionality to XPhyto’s drug formulation business. In 2020, XPhyto reported significant advancements in four drug formulation development programs. About XPhyto Therapeutics Corp.

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