pharmaphorum

AUGUST 16, 2022

The highly anticipated Lipid Nanoparticle Immunogenicity & Toxicity Summit takes place this December to unite 80+ senior leaders as the definitive meeting for clinical pharmacology , immunogenicity , bioanalytical development leaders to stay at the forefront, arming you with practical takeaways and lessons learned.

Clinical Pharmacology 52

Clinical Pharmacology Immunity Immunization Vaccines 52

The Physician Pharmacist

OCTOBER 27, 2023

And so he put the, you know, he there was a seed there, but he definitely watered the seed in me about going to medical school. And you're right, not having that that background definitely was another challenge, compared to some of my other courses that I'm experiencing right now. It was just it was it was beyond belief.

Medical Schools 52

Medical Schools Medical Records Hospitals Clinical Pharmacology 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The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology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.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59

FDA Law Blog: Biosimilars

OCTOBER 28, 2024

To this end, FDA recently announced the publication of a guidance titled “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development,” (the “Guidance”). This guidance finalizes a draft guidance issued in February 2023.

Clinical Pharmacology 64

Clinical Pharmacology Communication Drug Development 64