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Figure 5 Documentation of drug exposure of the study population.
Documentation of drug safety is highly important, especially in pediatric drug trials.
To establish the internal validity of our automated query, a clinician reviewed all surgeries meeting inclusion criteria during one week in April 2008 (N=30), searching for appropriate medication orders and documentation of drug administration or evidence of compression device application.
These epidemiologic studies suffer from lack of randomization and the resulting potential for unintentional channeling biases, from lack of rigorous documentation of drug actually taken and of nonprescription drugs administered concomitantly, and from dependence on diagnoses defined to meet coding requirements for insurance payments, without supporting documentation or detailed event descriptions.
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We excluded patients who died in hospital; lacked documentation of drugs prescribed at discharge; concomitantly used an ACE inhibitor and angiotensin receptor blocker; or had a left ventricular ejection fraction <40% or lacked information on left ventricular ejection fraction.
Each patient was asked to return the previously dispensed study drug bottle for documentation of study drug compliance.
Specifically, the discrepancies included either different doses of medications or documentations of drugs not purchased at all, or vice versa, drug purchase without nurse documentation.
The project aims to meet the information needs of the practicing physician by combining clinical guidelines with documentation of regularly updated scientific evidence and reliable documentation on drug descriptions.
The diagnosis of chronic hypertension required medical record documentation of antihypertensive drug therapy or a blood pressure measured in the sitting position equal to or greater than 140/90 mmHg taken on two occasions at least four hours apart, either before conception or during pregnancy but prior to study entry and before gestational week 20.
Infant discharge ICD9 codes were reviewed for documentation of infant drug withdrawal (ICD9 code 779.5).
The quality and safety have to be addressed in the application documentation of the drug product.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com