Successful drug development requires getting critical development and regulatory decisions right and it is common knowledge that all drugs must undergo rigorous testing before they can be safely used in patients.
Pharmacokinetic (PK) and toxicokinetic (TK) inspection are two important and related ways of ensuring the safety of a drug. The results of PK and TK inspections allow pharmaceutical companies to make informed decisions regarding the safety profile of the drug and whether it is worth pursuing the continued development of the drug.