FDA Law Blog: Biosimilars

JULY 17, 2024

In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

Clinical Pharmacology 105

Clinical Pharmacology Drug Development 105

Pharmacy Joe

JANUARY 11, 2023

However, a study published in 2012 in BMC Clinical Pharmacology challenges that concept and seems to show that at very high doses there must be some form of passive, non-saturable absorption of thiamine. Healthy subjects were given oral thiamine at doses of 100 mg, 500 mg, and 1500 mg.

Clinical Pharmacology 52

Clinical Pharmacology Inpatient Hospitals 52

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.

Clinical Pharmacology 40

Clinical Pharmacology Inpatient Dosage Documentation 40

Pharmacy Joe

JANUARY 11, 2023

However, a study published in 2012 in BMC Clinical Pharmacology challenges that concept and seems to show that at very high doses there must be some form of passive, non-saturable absorption of thiamine. Healthy subjects were given oral thiamine at doses of 100 mg, 500 mg, and 1500 mg.

Clinical Pharmacology 40

Clinical Pharmacology Inpatient Hospitals 40

The Physician Pharmacist

OCTOBER 27, 2023

⚡️ For more resources to get started, check out some of our other blog post content! And so yeah, I'm the founding lecturer and basic clinical pharmacology to this PA program. I developed and implemented a whole course in clinical pharmacology 24 lectures, each lectures two and a half hours and exams and it was a lot of fun.

Medical Schools 52

Medical Schools Medical Records Hospitals Clinical Pharmacology 52

Putting Patients First Blog

SEPTEMBER 26, 2024

Clinical Pharmacology & Therapeutics , 97(3) , 263–273. Participation of women in clinical trials supporting FDA approval of cardiovascular drugs. Pacanowski, M., and Zhang, L. Racial/ethnic differences in drug disposition and response: Review of recently approved drugs. 8 Scott, P., Jenkins, M., Southworth, M.,

Communication 52

Communication Clinical Pharmacology Documentation Drug Development 52

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. Stay tuned for the next iteration of the Cliffs Notes to the Cliffs Notes.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59