pharmaphorum

OCTOBER 11, 2022

Therefore, to help contextualise study findings, external comparator arms (ECAs) can be employed, which compile data from external sources, such as patient registries and other medical records. In the general case, RCTs are the optimal approach to clinical research and drug development. Discussion.

Documentation 98

Documentation Medical Records Dosage Drug Development 98

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,

Drug Development 64

Drug Development Documentation Labelling Medical Records 64

Viseven

JANUARY 4, 2023

This article will cover the most important areas of AI influence on the pharma industry and new drugs development. From life-saving drugs discovery, development, and production to clinical trials, communication, and drug target identification — AI pharmaceutical is a definite game-changer. Clinical Trials.

Drug Development 52

Drug Development Medical Records Communication Pharmaceutical Companies 52