Bioequivalence Study of Drugs: Its Facilities and Techniques
Contents: 1. Introduction. 2. Essential Components required for BA/BE Study Centre. 3. Ethical Perspectives. 4. Pre-requisites for Conducting BA/BE Studies. 5. Methods to Conduct BE Study. 6. Contents of a BE Study Report. 7. Summary. 8. LC-MS/MS Instrumentation. 9. References and Appendices. This book has been designed to illustrate the concept and practice of Bioavailability and Bioequivalence Studies and will definitely beneficial to them who are interested to proceed further in this field. India is the largest provider of generic drugs globally. Availability of the generic products in the market has been gained serious public consideration in respect of their safety and efficacy with the innovator products. Bioequivalence (BE) studies with a view to demonstrate therapeutic equivalence between two drug products (test and reference or innovator) can able to answer this public concern internationally. The aspect of bioequivalence study is not included in the syllabus of pharmacy or MBBS, this will be definitely helpful to the pharmacist, doctors and the pharma industries to have a thorough knowledge regarding this subject as well as it will guide them to establish a Contract Research Organizations (CRO) for conducting BA/BE study. Moreover it is obvious that the technology transfer from existing CROs for conducting BA/BE study is not possible due to commercial reason. In our book attempts were made to elaborate the CPU and the bioanalytical labs with specimen layout plan, list of essential instruments, and list of SOPs for conducting BA/BE studies etc. Prior to any study the approval of ethics committee is mandatory. Procedure of getting the approval along with the composition of ethics committee has been highlighted. The contents of protocol to conduct BA/BE study including ICF, CRF, PIS, IB, IU and preclinical study of volunteers along with procedure for reporting SAE have been discussed in details.