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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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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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Indian biotech start-ups: Need for pragmatic, pro-active, progressive regulatory milieu

Express Pharma

The regulatory system is based on New Drugs and Clinical Trials Rules (NDCTR) 2019, guidelines, processes, checklists, and review by advisory committees. Department of Biotechnology or the Indian Council of Medical Research (ICMR) have an advisory role for certain product categories. The rules are often amended through Gazette Notifications.

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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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