Techniques
Pharmacokinetics & Statistics
Pharmacokinetic studies are conducted such that each of the drugs is administered in a crossover fashion to healthy volunteers. To compare the two drugs, plasma is obtained at regular intervals and assayed for parent drug or metabolite concentration. Plasma concentration data are used to assess key pharmacokinetic parameters when comparing two formulations. Bioequivalence is established when a 90% confidence interval for the ratio of the geometric least square means of peak plasma concentration, the area under the curve of test and reference drugs is within 80–125%.
The AnaCipher team is well equipped and trained to conduct PK studies with effective plans and strategies in place, including risk-mitigation strategies.
Biostatistics and Data management:
Our integral biostatisticians and data management team are experts in collecting, analysing, and interpreting data from clinical trials which are accurate, reliable and reproducible.
AnaCipher is equipped with software tools which are in compliance with industry standards and regulatory guidelines. Our deep expertise in clinical biostatistics enhances efficiency and mitigates risks in study design, conduct and conclusion. Our Biostatistics and Data Management is well equipped with the latest software like MedDRA, WinNonlin and SAS programs.
Advanced Clinical Biostatistics Services
- Study design
- Randomization
- Regression analysis
- Pharmacokinetic and statistical analysis of data for PK and In-Vitro BE studies using SAS
- Study design
- Choice of endpoints
- Statistical analysis planning
- Sample size calculation
- Trial simulations
- CDISC services
- Key risk indicators
- Central statistical monitoring
- Statistical and strategic consulting
- Representation at the regulatory authorities
- Integrated summaries of Safety and Efficacy
