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Renal Drug Dosing References

RX Note

Introduction Individualization of a drug dosage regimen for a patient with impaired kidney function is based on the pharmacodynamic/pharmacokinetic characteristics of the drug, the patient's degree of residual renal function, and the patient's overall clinical condition.

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PMPRB launches consultation on revised Draft Guidelines

Pharma in Brief

On November 29, 2019, the PMPRB launched a 60-day consultation on its first set of Draft Guidelines to implement the amended Regulations. That consultation was subsequently extended and, according to the PMPRB , resulted in “extensive feedback” including at least 123 written submissions published to the PMPRB’s website.

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UK approves prescription-only melatonin drug for childhood ADHD

Pharmaceutical Technology

In July 2019, the MHRA held up Colonis for sending a letter to physicians advertising the off-label use of the drug in children and those with renal impairment. The recommended dosage is even smaller in children. Colonis Pharma is a subsidiary company within Clinigen.

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The case for AI and machine learning in life sciences

Pharmaceutical Technology

GlobalData forecasts that the market for AI platforms for the entire healthcare industry will reach $4.3bn by 2024, up from $1.5bn in 2019 [i]. Consent documents often describe technical medical conditions and regulatory bodies are increasing pressure on sponsors to ensure that patient-facing information can be easily understood by patients.

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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmaTech

Pharmacist weighing chemical | Image Credit: © Kzenon - stock.adobe.com Performing calculations for the formulation of pharmaceutical dosage forms and related preparations is a key activity in compounding. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Policy-exception salts.

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ICH Q6B for Analytics

PharmaTech

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals.

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Black Seed Oil and Hashimoto’s

The Thyroid Pharmacist

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] The trial used dosages of 1, 2 and 3 grams of black seed oil per day, and found that the 2 gram per day dose was the most effective. Published 2019 May 12.

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