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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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2022 spells change for EU pharmaceutical legislation

European Pharmaceutical Review

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. Brussels; 2020. EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION; 2022.

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Roivant joins RNA splicing push with Eisai deal

pharmaphorum

The compound, called H3B-8800, is currently in phase 1 testing in the US and Europe in patients with myelodysplastic syndrome (MDS) who carry mutations in splicing factor 3B subunit 1 (SF3B1) by Eisai’s H3 Biomedicine subsidiary.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

11 The THR pathway was created with the purpose of establishing a simplified registration procedure for all traditional herbal medicines that do not fulfil the requirements for the MA (strict) pathway under Directive 2001/83/EC. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation. 2012/1916).

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Three strategies for managing loss of exclusivity successfully

pharmaphorum

Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. AstraZeneca’s patent for its top-selling gastroesophageal reflux disease drug was due to expire in 2001. Simultaneous with the switch to NEXIUM, AstraZeneca grew its overall Gastroenterology franchise – by nearly 9% from 2001 to 2002.

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PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

The first concept for a PROTAC was published in 2001, and recently these protein degraders have gained rapid momentum as a promising novel modality. This makes early R&D less risky, as many lead compounds are discontinued due to inadequate pharmacokinetic profiles and require excessively high dosages to be pharmaceutically active.

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Brain Fog and Hashimoto’s

The Thyroid Pharmacist

Compounded medications : If NDT medications do not seem like a good fit for you, compounded T4/T3 products offer another alternative. Thyroid compounds are usually prepared in the same physiological ratio that is found in NDT products. I recommend 1-4 grams of fish oil per day, taken with a meal that contains quality fats.