Medications used by the DPP participants for management of diabetes were recorded every 6 months on a drug summary form.
The final results thus obtained from the above pipeline are presented in the Drug summary and consist of the PubMed ID of the paper, the support sentence and, if specified, the related disease and the experimental techniques.
Each drug-specific document includes a description and mechanism of action of the drug, summary of the key publications supporting the PGx evidence, and the PhAESIS evidence scoring of key genetic variants, drug-specific genotype-phenotype correlations and predicted drug response interpretations.
Similar difficulties have been encountered with drug summaries of product characteristics.
A recent national plan to promote judicious use involved amending antimicrobial drug summaries of product characteristics, as well as amending treatment guidelines and the provision of free streptococcal tests and information for patients and parents (B. Schlemmer, pers. comm).
In a previous study on drug summaries of product characteristics (SPCs) [ 19, 20], we proposed the Visualization of Concepts in Medicine (VCM), a language that uses icons to represent medical concepts including symptoms, disorders, physiological states (such as age class or pregnancy), risk and history of disorders, drug and non-drug treatments, lab tests and follow-up procedures.
Drugs were categorized as benefitting from accelerated approval using FDA documents including "accelerated and restricted approvals under subpart H (drugs) and subpart E (biologics)," 28 "CDER drug and biologic accelerated approvals as of September 30 , 2011" 29 and the FDA's annual new drugs summaries.
Drugs were categorized as subpart E or fast track drugs using an FDA document entitled "CDER fast track products approved since 1998 through June 1 , 2010" 26 the FDA's annual new drugs summaries, a law review article, 27 and information provided by the FDA under the Freedom of Information Act.
Obligatory inclusion of the drug's summary of product characteristics.
Each pair was classified as potential positive or negative control based on information from the drug's Summary of Product Characteristics and Micromedex.
We reviewed all pages of a drug's summary review, Medical Review(s), Chemistry Review(s), Pharmacology Review(s), Statistical Review(s), Clinical Pharmacology Biopharmaceutics Review(s), Risk Assessment and Risk Mitigation Review(s), and other reviews to create a list of every clinical trial reviewed by the FDA to approve each drug.
