BA/BE TK/TP Analysis
Maxxam provides assistance for pre-clinical and toxicokinetic (TK) studies. Bioanalytical testing services can be provided for pharmacokinetic (PK) screening in rodents, dogs and monkeys prior to GLP studies.
High-volume GLP bioanalytical testing support is provided throughout the clinical drug development process, from Phase I to Phase IV. The laboratory conducts clinical bioanalysis using LC-MS/MS for a variety of clinical trials:
- “First-in-Man” Trials
- Dose-finding/Dose-escalation Studies
- Pharmacokinetic (PK) Studies
- Pharmacokinetic/Pharmacodynamic (PK/PD) Studies
- Bioavailability (BA) Studies
- Bioequivalence (BE) Studies
- Drug-Drug Interaction (DDI) Studies
- Food Effect Studies
- Therapeutic Drug Monitoring Studies
- Phase II or Phase III Clinical Trials with a PK Component
Maxxam also provides statistical and pharmacokinetic analysis services using SAS and WinNonLin programs to analyze bioanalytical data.
