BACKGROUND Previous research shows that existing asthma quality of life questionnaires fail to measure the burden of oral corticosteroids that can be used to treat severe asthma, and are therefore not fit for purpose for severe asthma according to the USA's Federal Drug Authority's (FDA) criteria for content validity. Patient input and documentation of that input is key to achieving content val...

this commentary discusses pertinent issues from hyosun kim’s paper on online prescription drug promotion. the study is well-designed and the findings highlight some of the consequences of the food and drug administration’s (fda’s) decision to deregulate online advertising of prescription drugs. while kim’s findings confirm some of the early concerns, they also provide a perspective of implement...

Regulatory criteria established for the acceptance of average bioequivalence do not fully satisfy the requirements arising for the interchangeability of drug products. The divergence is illustrated by noting that the regulatory criteria are compatible with large inter-individual variation of within-subject differences or ratios of the relevant kinetic parameters. Regulatory criteria of three ju...

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