REASONS FOR PARTICIPATION AND PROBLEMS ENCOUNTERED BY HEALTHY VOLUNTEERS IN BIOAVAILABILITY / BIOEQUIVALENCE STUDIESAbstract
Bioavailability / Bioequivalence (BA/BE) studies are conducted as a part of regulatory requirement to establish that the generic drugs are equivalent to the innovator drugs and are usually carried out in healthy human volunteers. They are nontherapeutic studies without any direct benefit to the participants. In spite of the lack of any direct personal benefit what makes some individuals to volunteer to take part in the study while others are not and what is their opinion about BA/BA studies is largely unknown. Hence the present study was conducted to find out the reasons for participation in BA/BE studies by healthy volunteers and the problems they encountered during the study participation. 112 healthy volunteers participated in this study and all of them were males. From their response, it is evident that 70 volunteers participated in BA/BE studies for monetary benefit. 64 volunteers were of the opinion that free health checkup they undergo in a BA/BE study helps to know their health status and they participated in the studies for this reason. 81 volunteers (72.32%) selected poor toilet facility in CROs as the significant problem. 66 volunteers (58.93%) have expressed that diet restriction was their problem. Inadequate compensation and poor quality of food served during the study were the problems for more than 40 volunteers. For more than 35 volunteers, side effects of the drugs, improper housing facility and frequent blood sampling were the problems during their participation.
R. Arun Kumar*, A. Ruckmani, K. Hariharan , R. Lakshmipathy Prabhu and A. Priya
Associate Professor, Department of Pharmacology, Chettinad Hospital and Research Institute, Kelambakkam– 603103, Tamil Nadu, India
01 January, 2013
20 March, 2013
27 April, 2013
01 May, 2013