Final answer:
The Clinical development group is responsible for developing plans and protocols for human drug testing within a drug development company. It ensures that all clinical trials are in compliance with regulations set by the ICH, EMA, and FDA, leading to a successful NDA submission for drug approval.
Step-by-step explanation:
The group in a drug development company that is in charge of developing study protocols, plans, and budgets for drug testing in human subjects is the Clinical development group. This group oversees the entire clinical trial process, which includes creating detailed plans for the phases of trials required to demonstrate the safety and efficacy of a new drug. Clinical development is guided by strict regulations and guidelines provided by authoritative bodies such as the International Conference on Harmonisation (ICH), European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA).
Clinical development starts with Phase I trials, which primarily assess the safety and pharmacokinetics of a drug in humans. If successful, the drug progresses through further phases that evaluate its efficacy and monitor for any adverse effects. The ultimate goal is to collect significant data to support the submission of a New Drug Application (NDA) to the FDA for approval.