The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the change in RoA required a single-species, one-month good laboratory practice (GLP) toxicology study. From a clinical pharmacology perspective, the sponsors also needed to establish a scientific bridge for relying on the data contained in the product labeling of the LD. Human factors.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 52

Agency IQ

DECEMBER 1, 2023

For such studies, the FDA recommended a primary endpoint of laboratory-confirmed SARS-CoV-2 infection with or without symptoms. While the concept of quantitative systems pharmacology (QSP) has been around for several decades, the prospect of actually using these models in regulatory applications is still quite new.

FDA 40

FDA Clinical Trials Vaccine Trials 40

The Pharma Data

FEBRUARY 8, 2021

2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea and fracture. Laboratory Abnormalities — All Grades (Grade 3-4).

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA 40

FDA Science Biosimilars Clinical Trials 40