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Concerns for Antibodies in the Clinic<br />
Clinical Concern Clinical Outcome<br />
Safety<br />
Efficacy<br />
Pharmacokinetics<br />
None<br />
•Neutralize activity of endogenous<br />
counterpart with unique function<br />
causing<br />
deficiency syndrome<br />
• Hypersensitivity Enhancing or decreasing reactionsefficacy<br />
by<br />
extending or decreasing half life.<br />
• Enhancing or decreasing efficacy by<br />
changing biodistribution.<br />
• Antibody production may dictate<br />
changes<br />
in dosing level due to PK changes.<br />
• Despite generation of antibodies, no<br />
discernable impact
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