They make sure the manufacturing controls, quality control testing and packaging are adequate to preserve the drug product's identity, strength, potency, purity and stability. Physicians evaluate the results of the clinical trials, including the drug's adverse and therapeutic effects, and determine if the product's benefits outweigh its known risks at the doses proposed. Project managers orchestrate and coordinate the drug review team's interactions, efforts and reviews. They also serve as the review team's primary contact for the drug industry. Statisticians evaluate the designs and results for each important clinical study.
Microbiologists evaluate the effects of anti-infective drugs on germs.
Another group of microbiologists evaluates the manufacturing processes and tests for sterile products, such as those used intravenously. Biopharmaceutists evaluate the rate and extent to which a drug's active ingredient is made available to the body and the way it is distributed, metabolized and eliminated. They also check for interactions with other drugs. Clinical pharmacologists evaluate factors that influence the relationship between the body's response and the drug dose. They assist physician members of the team in assessing the clinical significance of changes in the body's response to drugs through the use of exposure-response relationships.