The potential for a drug to cause serious harm.

Toxicity (Drug Development)

The step of laboratory and animal testing to gauge toxicity. Answers questions of specific levels of toxicity and dosing. Two types consist of in vitro (outside) and in vivo (inside). 

Calvin College

- 1: Drug Discovery and Development
- 2: Preclinical Research
- 3: Clinical Research 
- 4: FDA Review
- 5: FDA Post-Market Safety Monitoring

Steps in The Drug Development Process

U.S. Food and Drug Administration

The initial step of laboratory research for a new drug.

1: Drug Discovery and Development

2: Preclinical Research

The step of conducting drug trials on volunteers. Answers questions on how a drug specifically interacts with the human body. This step consists of four phases, starting from the tens and going up to the thousands for volunteers.

3: Clinical Research

The step of approving a drug to circulate into the market or not. Involves making a new drug application (NDA). If the NDA is deemed complete by review, there is a 6-10 month process to approve or deny a drug.

4: FDA Review

The coverage of the FDA that deals with manufacturer inspections, drug advertising, any changes from the drug developer (ex. labeling, administration form), and reporting problems.

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