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FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs

PharmaTech

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

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Case Study 4 – Successful US/EU Marketing Applications for Big Pharma

Syner-G

As a result of repeat business, IMPACT (now part of Syner-G BioPharma Group) was contracted by a large, global pharmaceutical company to author the CSRs and accompanying submission documents to support a simultaneous US and EU submission for a combination respiratory product. and 2.7.2), and the Clinical Overview (Module 2.5).

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Episode 573: Ceiling dose of ketorolac for renal colic in the ED

Pharmacy Joe

In 1989, a study in the Journal of Clinical Pharmacology compared 10, 30, and 90 mg of IM ketorolac with placebo in 126 patients with cancer pain. While all doses were more effective than placebo, there was no difference in effectiveness between 10, 30, or 90 mg of IM ketorolac.

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The future of medical cannabis development in Europe

European Pharmaceutical Review

5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events. An observational study of safety and clinical outcome measures across patient groups in the United Kingdom Medical Cannabis Registry.

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COVID-19 has propelled the regulatory industry years ahead

pharmaphorum

And advances in digitalisation could facilitate a move from document-based submissions to data-based submissions, through a cloud platform like the one being developed by Accumulus Synergy. Regulators and pharmaceutical companies are investigating cloud-based platforms to enable the real-time sharing of data. Published 2021 Apr 9.

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