Designing pharmacokinetic studies for bioequivalence assessments. Developing study designs for clinical programs on products for clients. Managing activities of a study from design inception through study results. Providing advice on statistical contents to study designs.
Our extensive experience in handling pharmacokinetics data and interpreting the results makes it easier to design successful bioequivalence studies. The correct use of existing pharmacokinetic information from past studies and literature is paramount to designing a potentially passing BA/BE study. HT Pharmaceuticals will align Phase I-III study activities with the study design and protocol. With a strong background and understanding of biostatistics, HT Pharmaceuticals will ensure study activities meet the statistical requirements of data collection. Avoiding errors during the study implementation stage is preferable to uncovering discrepancies during data analysis when it is too late to correct them.