Development and Validity of Questionnaire for Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study

Abstract

Participation of humans in clinical research is always remained questionable. Hence evaluation of such doubt helps to conclude the perception about such participation. This research presents the process for development and validation of questionnaire for Healthy Adult Human Participants of Early Phase Bioequivalence Pharmacokinetic Endpoint Study. For development of questionnaire, literature search, experts’ discussion and authors’ experience was used for domain identification and its segregation for different variables. For validity of questionnaire, face validity and content validity was performed. Modification was done based on response from experts during non-quantitative face validity. % of overall agreement was 94.55 for question asked in face validity. While, Content Validity Ratio and Content Validity Index was calculated using the process mentioned by Lawshe and Lynn respectively. Initially 83 items were identified but based on validation 84 items were finalized after removal of three and addition of four questions. Deleted three items had Content Validity Ratio of 0.00, 0.67 and 0.67 and which were below accepted level of 0.99. While, I-CVI was observed from range of 0.83 to 1.00 and S-CVI values were above acceptable level of 0.90 for S-CVI (S-CVI/ Ave) and 0.80 for S-CVI (S-CVI/UA) for whole questionnaire and each part.