Bioquivalence

Apotex formulates their products to be equivalent to the innovator brand. The testing methods employed are some of the most rigorous used anywhere in the world and they incorporate bioequivalence studies comparing the two products.

The bioequivalence team supports protocol development to completion of the clinical trial report for regulatory submissions.

Apotex has a competent team and the staff is trained to international standards for conducting the clinical studies.

Clinical Operations department occupies over 4500 sq. m. of carpet area and has the capacity to house more than 150 subjects in its state of the art facility. The department conducts the clinical portion of Bio studies for Apotex. The clinic team is responsible for recruiting healthy human volunteers, screening activities including counseling, collecting and summarizing screening data and ensuring appropriate follow-up of abnormal medical results and overall management of studies including study and safety monitoring, collecting and summarizing clinical data. In addition to the above the department is also responsible for protocol writing and study design, Case report form design, Independent ethics committee submissions (Protocols, CRFs, ICF) monitoring of Adverse events and Preparation of Reports.

Bioanalytical Laboratory team is involved in the Drug and/or metabolite(s) assay for pharmacokinetic studies. Their key strength lies in their ability to develop and validate complex methods well in advance based on business requirements, Adept in handling protein precipitation, liquid-liquid extractions, solid phase extractions and derivatization techniques.

Pharmacokinetics team is responsible for designing bioequivalence studies based on the pharmacokinetics of the study drug, and writing bio-study protocols. Their key strength lies in their experience in designing and data handling of multiple dose studies, parallel design studies, reference replicated design studies and PK/PD studies.