ALiEM - Pharm Pearls

NOVEMBER 1, 2023

Clinical pharmacology, therapeutic use and potential of COMT inhibitors in Parkinson’s disease. 22 Aug 2018. Medicine (Baltimore) 1999;78(6):361-9. PMID 10575418 Kaakkola S. 2000 Jun;59(6):1233-50. PMID: 10882160 The meaning behind the color of urine. The Meaning Behind the Color of Urine – Urology Care Foundation.

Clinical Pharmacology 161

Clinical Pharmacology Dosage Compounding 161

PharmD Live

MAY 30, 2024

British Journal of Clinical Pharmacology, 67(6), 689–700. Retrieved from British Journal of Clinical Pharmacology Jyrkka, J., Clinical consequences of polypharmacy in elderly. British Journal of Clinical Pharmacology, 74(4), 627–633. Watanabe et al., A., & O’Mahony, M. Korhonen, M. Hilmer, S.

Clinical Pharmacology 119

Clinical Pharmacology Hospitals Long-Term Care Facilities Dosage 119

FDA Law Blog: Biosimilars

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

Clinical Pharmacology 104

Clinical Pharmacology Drug Development 104

PharmaShots

APRIL 6, 2023

A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.

Biosimilars 53

Biosimilars Clinical Pharmacology 53

RX Note

JANUARY 21, 2023

Regardless, this post is solely created as a collection of recommended reference.

Compounding 40

Compounding Community Pharmacies Clinical Pharmacology Dosage 40

Eye on FDA

AUGUST 4, 2021

At the same time, looking to 2018 when there were 29 meetings to consider new drugs, the number appears to be falling each year, with only 6 that occurred during the first half of 2021. Fewer meetings – more approvals. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

Clinical Pharmacology 122

Clinical Pharmacology Compounding Vaccines 122

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

Labelling 62

Labelling Biosimilars Adverse Reactions Dosage 62