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The challenge of handling highly potent API and ADCs in analytical chemistry

European Pharmaceutical Review

Some examples of HPAPIs are cytotoxic compounds and hormones such as oestrogen. A new compound of unknown potency and toxicity. Over 25 percent of total drugs worldwide are classified as containing HP compounds and 30 percent of product candidates in the development pipeline are also HPAPIs, showing that this trend will continue.

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ACMT Toxicology Visual Pearl: Who Doesn’t Like a Nice Rosé?

ALiEM - Pharm Pearls

 Deferoxamine binds with ferric iron (Fe3+) to form ferrioxamine, a water-soluble compound excreted in the urine. As Hypersensitivity reactions to rifampin: Pathogenetic mechanisms, clinical manifestations, management strategies, and review of the anaphylactic-like reactions. Medicine (Baltimore) 1999;78(6):361-9.

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New radiopharmaceutical laboratory opens in Germany

European Pharmaceutical Review

Additionally, the new laboratory offers Ariceum the ability to carry out on-site process, method, validation and formulation development as well as preliminary stability analysis of its radiolabeled compounds.

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From Healing to Harm: The Unintended Consequences of Polypharmacy in Seniors

PharmD Live

The side effects can compound, resulting in a greater negative impact on a patient’s health than the individual effects of one medication alone. British Journal of Clinical Pharmacology, 67(6), 689–700. Retrieved from British Journal of Clinical Pharmacology Jyrkka, J., A., & O’Mahony, M. Korhonen, M.

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AdComms – Is FDA Getting Less Advice?

Eye on FDA

When Breakthrough Therapy (BT) designation is granted, then the drug gets Fast Track status and receives more intensive guidance – which can begin as early as Phase I clinical trials. That said, BT would be a lagging indicator since it can be granted so early in the development process.

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FDA Advisory Committee Review of 2021

Eye on FDA

Here is where FDA currently has vacancies: Bone, Reproductive and Urologic Drugs Advisory Committee – 4 vacancies Gastrointestinal Drugs Advisory Committee – 1 vacancy Pharmaceutical Science and Clinical Pharmacology Advisory Committee – 4 vacancies Pharmaceutical Compounding Advisory Committee – 1 vacancy.

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Online Medical Resources

RX Note

IWK Compounding Formulas USP-NF WHO Pharmacopoeia Pregnancy Australia TGA Best Use of Medicines in Pregnancy Pregnancy and Breastfeeding Medicines Guide