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Extemporaneous Preparation with Unknown Stability

RX Note

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Pharmaceutical Technology

Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014.

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Speaking of Medicine – Mid-Year OPDP Enforcement Review

Eye on FDA

And since 2014 the Office of Prescription Drug Promotion (OPDP) has broken double digits only 3 times, producing only 6 letters in both 2020 an 2021. The characterization of investigative data resulted in a violation related to promotion of an unapproved compound. In 1998, there were 156 letters issued in a single year.

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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

Introducing an irinotecan tablet formulation, in combination with other effective oral compounds, provides the opportunity for patients to receive an all-oral, metronomic chemotherapy with better efficacy in a more convenient and cost-effective regimen. accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf [Accessed 25.01.22].

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Innovating for Individual Care: The Impact of USP on Personalized Medicine

Quality Matters

USP has a long-standing history of healthcare standards including those for compounding preparations that are tailored to meet the unique needs of patients who may not otherwise have access to their medications. Washington (DC): 2014; pharmacogenomics working group whose mission is to develop a 56. Nature 520, 609–611 (2015).

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Turmeric for Your Thyroid and Hashimoto’s

The Thyroid Pharmacist

Benefits and Uses of Curcumin Turmeric’s medicinal benefits can mostly be attributed to compounds called curcuminoids. Combining curcumin with piperine, an alkaloid found in black pepper, extends the life of curcumin in the body, making its compounds more therapeutically effective. 2014 Jul;69:182-201 [2] Prasad S, Aggarwal BB.

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

European Pharmaceutical Review

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. The intricate nature of botanical products further compounds the challenge, demanding a paradigm shift in regulatory interpretation and QC standards. 2024 [cited 2024May].