Newsletter | November 18, 2024

11.18.24 -- Intranasal Delivery For Post-Viral Smell Loss With Cyrano Therapeutics

FEATURED EDITORIAL

Intranasal Delivery For Post-Viral Smell Loss With Cyrano Therapeutics

COVID-19 and other viruses have drawn increased attention to the debilitating effects and potentially consequential underlying causes of hyposmia or anosmia (reduced or complete inability to smell). In this episode of Sit and Deliver, Rick Geoffrion, founder and CEO of regenerative medicine company Cyrano Therapeutics, talks about why an effective therapeutic response may well involve – you guessed it – a payload through the nose.

The Role Of ISO 13485 In The New QMSR

What does adding ISO 13485 as a reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment of New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies explains the relationship between the two guidance documents.

INDUSTRY INSIGHTS

Why 'Off-The-Shelf' Devices Do Not Circumvent Design Controls

Using off-the-shelf (OTS) devices can significantly benefit development programs. When utilizing OTS devices, understand the sponsor's design control responsibilities.

Autoinjectors: A Revolutionary Leap In Drug Delivery

Explore how the widespread adoption of autoinjectors is transforming the biopharmaceutical industry's approach to drug delivery, offering precise dosing, patient adherence, and safety.

Nanoforming Vs. ASDs: Enhancing Bioavailability And Patient Convenience

Review the pros and cons of marketed amorphous solid dispersions with new, unpublished data, and explore a green alternative: advanced nanotechnology for nanocrystal manufacturing.

Pediatric Patient Considerations During Dose Development

Specific dosing guidelines and acceptable dosage forms for pediatric patients need to be developed to optimize therapeutic efficacy and limit and prevent serious adverse side effects.

Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device

How to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

Diagnose Absorption Risks To Improve Preclinical And Clinical Outcomes

Physiologically based pharmacokinetic modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and accelerate timelines.

SOLUTIONS

Real World Dosing Solutions For Patients

Easing Oral Dose Delivery With Parvulet Technology

Services And Products For Packaging, Containment, And Delivery Systems