Supporting The customer In Pharmacokinetic Bioanalytical Study,
BA/BE Study,Bioanalytical Testing, Phase I Study And Bridging
Study Of Drug
Pharmacokinetics and BA/BE Study
Study Protocol Design
Study MonitoringSite Management
Medical writing/Final Report
Animal Samples : Rat, Dog, Rabbit
Specimen : Plasma, Blood, Urine, Tissue…
Validation method development
Phase I Study
Rosetta’s Phase I study site is via cooperation with Taipei Medical University, and the clinical facilityhas been set up at the Shuang-Ho Hospital (the affiliated hospital of Taipei Medical University)
For Phase I trial environment in Taiwan is required to be conducted in Phase I unit, that must have comprehensive facility, including:
Pharmacokinetics study (beagle dog, mini-pig, rat, mice)
Development of drug (evaluation of bioavailability)3. Maximum tolerated dose (MTD) test.
PK study design (blood sampling time, administration, specimen).
Pharmacodynamics study (xenograft , nephritis, etc.)
Animal protocol review.
Animal housing service
Investigational new drug (IND) application consultation.
Regulatory compliance solution