Pharmacokinetics and pharmacodynamics
Methods for measurement of drug concentrations in serum
and body fluids must be provided. If bioassay and other meth-
ods are available, their relative performance must be shown.
Actual plots must be provided of serum or plasma levels in
humans over time following expected dosages and methods of
administration. Concentrations in cerebrospinal fluid must be
presented if the drug is to be used for the treatment of meningitis. If available, data from target patient populations should
be presented.The number of subjects or patients, characteristics, and intra-and interindividual variability of measurements must be included.