FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs
PharmaTech
DECEMBER 15, 2023
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
AUGUST 9, 2022
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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COVID-19 has propelled the regulatory industry years ahead
pharmaphorum
OCTOBER 18, 2021
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.
FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)
FDA Law Blog: Biosimilars
DECEMBER 6, 2024
As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.
Episode 573: Ceiling dose of ketorolac for renal colic in the ED
Pharmacy Joe
JANUARY 10, 2021
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.
The future of medical cannabis development in Europe
European Pharmaceutical Review
JULY 13, 2023
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.
NHC Comments on Landmark FDA Guidance for Diversity in Clinical Trials
Putting Patients First Blog
SEPTEMBER 26, 2024
Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. Clinical Pharmacology & Therapeutics , 97(3) , 263–273.
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