Services

Supporting The customer In Pharmacokinetic Bioanalytical Study,
BA/BE Study,Bioanalytical Testing, Phase I Study And Bridging Study Of Drug

IMG_0068
IMG_0054
SAM_3793
SAM_3874
AF3
AF2

Service Scope

Pharmacokinetics and BA/BE Study

Study Protocol Design
Subject Recruitment
Study MonitoringSite Management
Data management
Data Analysis
Biostatistics
Medical writing/Final Report

Bioanalytical

Human Samples
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:

  • Standard procedure for phase I study
  • Healthy volunteer recruitment
  • Professional full-time study nurse
  • Monitor / emergency equipment
  • Study management

Animal Study

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.

Bridging Study

Consultation

Regulatory consulting
Regulatory compliance solution
IRB submission
TFDA submission

Address

3F., No. 108, Minquan Rd., Xindian Dist., New Taipei City 231 , Taiwan (R.O.C.)

Call Us

+886 2 8218-6218

Email Us

service@rosetta.com.tw