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evaluation of ADA emergence may assist in the overall assessment of the drug’s possible
liabilities and help explain toxicological observations related to formation of drug: ADA com-
plexes such as elicitation of immune responses (e.g., immune complex deposition in tissues,
complement activation, hypersensitivity reactions).
Summary
The development of peptides, therapeutic proteins, and mAbs has greatly expanded the
available types of molecules to address medical needs, but has also necessitated development
of tools and methods specific for these molecules. Best utilization of these complex molecules
requires thorough characterization of the molecules and understanding of their interactions
with physiologic systems. PK and PD methods and tools have been developed to evaluate
the molecules and integrate drug exposure and in vivo responses. Bioanalytical methods
and tools have been developed and refined to provide the essential quantitation for exposure
and responses. PK, PD and bioanalytics should continue to work closely together to facilitate
nonclinical development of the new generation of biopharmaceuticals.
Acknowledgment
We gratefully acknowledge Melinda Marian, Merck Research Laboratories, Palo Alto, CA, and Wolfgang Seghezzi,
Merck Research Laboratories, South San Francisco, CA, whose work on the first edition laid the essential foundation
for this revised chapter.
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