Souphalak Inthaphatha, Viengsakhone Louangpradith, Leyla Isin Xiong, Valee Xiong, Ly Ly, Vue Xaitengcha, Alongkone Phengsavanh, Nobuyuki Hamajima, Eiko Yamamoto
Menstrual health and factors associated with school absence among secondary school girls in Luang Prabang Province, Lao People's Democratic Republic: A cross-sectional study
PloS one
swallowability solid oral dosage forms sodfs crucial medication safety adherence regulatory agencies sponsors concerned bringing swallowable sodfs patients however best practices available assessing swallowability therefore conducted comparative analysis clinical swallowability assessments csas sodfs regulatory submissions identify current study design practices csas identified swallowability keyword search food drug administration database notable design trends among 17 csas assessing swallowability primary endpoint 76 enrolling pediatric patients 76 administering assessments postscreening 76 utilizing questionnaires 100 design trend near equal frequency50 single multipledoses product administration study subjects primary questionnaire respondents 82 usually using likert scale 92 1213 csas generally dichotomized responses analysis 65 without prespecified threshold values 59 overall study designs exhibited trends methodology variations may impact swallowability measurements affecting interpretation results thus developing robust valid assessment tools swallowability imperative produce clinically relevant data inform regulatory decisionmaking collaboration regulatory agencies sponsors warranted create best practices ensure high quality swallowability data