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The therapeutic index (TI; also referred to as therapeutic ratio) is a quantitative measurement of the relative safety of a drug with regard to risk of overdose.It is a comparison of the amount of a therapeutic agent that causes toxicity to the amount that causes the therapeutic effect. [1]
A drug-therapy (related) problem can be defined as an event or circumstance involving drug treatment (pharmacotherapy) that interferes with the optimal provision of medical care. In 1990, L.M. Strand and her colleagues (based on the previous work of R.L Mikeal [ 3 ] and D.C Brodie, [ 4 ] published respectively in 1975 and 1980) classified the ...
First-line therapy (sometimes referred to as induction therapy, primary therapy, or front-line therapy) [6] is the first therapy that will be tried. Its priority over other options is usually either: (1) formally recommended on the basis of clinical trial evidence for its best-available combination of efficacy, safety, and tolerability or (2 ...
CRA Treatment Plan. Establish meaningful, objective goals in client-selected areas. Establish highly specified methods for obtaining those goals. Tools: Happiness Scale, and Goals of Counseling form. Behavior Skills Training. Teach three basic skills through instruction and role-playing: Problem-solving Break overwhelming problems into smaller ...
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The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
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A priority review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The 2002 amendments to PDUFA set a goal that a standard review of a new drug application be accomplished within a ten-month time frame. The FDA goal for completing a priority review is six months.