| For each project, a study director and principal investigator are appointed. | ||
| The study drug (test and reference) is acquired along with the certificate of analysis (CoA). | ||
| The study specific protocol and informed consent form (ICF) are prepared. | ||
| The study specific protocol and informed consent form (ICF) are submitted to the independent ethics committee (IEC) for approval. | ||
| The volunteers are presented with the independent ethics committee (IEC) approved informed consent form (ICF). | ||
| On signing of the IEC approved ICF, Volunteers undergo the screening, medical examination and laboratory examinations. | ||
| Based upon the screening, medical examination and laboratory examination reports subjects for the study are selected. | ||
| A randomization schedule of the drug administration (test and reference) is prepared by the statistician. | ||
| The study is conducted as per the study specific protocol and SOPs. | ||
| The final report is prepared by the integration of the clinical report with the analytical report. | ||
