The initial step of laboratory research for a new drug.

1: Drug Discovery and 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). 

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.

5: FDA Post-Market Safety Monitoring

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

Calvin College

A multi-step process that aims to take a compound created from drug design and distribute it for public use.

Drug Development

U.S. Food and Drug Administration

Steps in The Drug Development Process

- Artificial intelligence to deep learning (Springer Link)
- Computer Aided Drug Design (CADD) slideshare
- PharmaEducation
- Promiscuous drugs compared to selective drugs (promiscuity can be a virtue)
- OMICS International 
- The Stages of Drug Discovery and Development Process
- U.S. Food and Drug Administration

Drug Development 1Cademy Sources

- What are some specific cases, if any, of these steps not being followed that have passed through FDA regulation anyway? What were the consequences?

- What steps are ignored in designing and marketing illegal drugs? Any steps followed?


Drug Development Steps Not Being Followed?

- What are ways to reduce the current costs in drug development? What role can AI and machine learning play in optimizing drug development?

Refining Drug Development

- Time: 12-15 years
- Money: ~ 1 billion USD

Learn Before

Related

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