Bioavailability Development Drug Delivery Production 
FDA Law Blog
JULY 23, 2024
Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.
Roots Analysis
MAY 21, 2024
In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility. Further, every year, poor bioavailability is one of the main causes of drug failure in obtaining approval authorization.
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Pharmaceutical Technology
FEBRUARY 13, 2023
Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.
Roots Analysis
OCTOBER 2, 2023
Owing to their unique size and physicochemical properties ( surface roughness, surface area, surface energy, crystal structure and shape ), nanoparticles can be widely used as a contrasting agent in medical imaging, a vesicle to cross the blood-brain barrier and a carrier for targeted delivery of genes / drugs, proteins, vaccines and antibiotics.
XTalks
JUNE 14, 2023
Novaliq, a biopharmaceutical company specializing in ocular therapeutics, recently announced that their product Vevye (cyclosporine ophthalmic solution) 0.1 percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. As a water-free product, it does not have an associated pH value or osmolarity.
Roots Analysis
MARCH 2, 2022
Interestingly, recent advances in this domain have led to the development of several treatment strategies that, according to developers, exhibit the necessary capabilities to overcome challenges posed by traditional oral protein formulations and peptide-based therapies. Oral Protein / Peptide-based Drugs.
Roots Analysis
FEBRUARY 20, 2022
Over the last decade, one of the major challenges faced by pharmaceutical players across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility. Nanoparticles Contract Manufacturing. Web: [link].
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