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There are numerous variables that influence the interpretation of drug concentration data: time, route and dose of drug given, time of blood sampling, handling and storage conditions, precision and accuracy of the analytical method, validity of pharmacokinetic models and assumptions, co-medications and, last but not least, clinical status of ...
Validation involves collecting documentary evidence of all aspects of compliance. [20] Hazard analysis and critical control points is a methodology which has been proven useful. [21] Quality assurance extends beyond the packaging operations through distribution and cold chain management; Good distribution practice is often a regulatory requirement.
Medication therapy management, generally called medicine use review in the United Kingdom, is a service provided typically by pharmacists, medical affairs, and RWE scientists that aims to improve outcomes by helping people to better understand their health conditions and the medications used to manage them. [1]
Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.
In medicine, compliance (synonymous with adherence, capacitance) describes the degree to which a patient correctly follows medical advice. Most commonly, it refers to medication or drug compliance, but it can also apply to medical device use, self care, self-directed exercises, or therapy sessions. Both patient and health-care provider affect ...
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.
The Beers Criteria for Potentially Inappropriate Medication Use in Older Adults, commonly called the Beers List, [1] are guidelines published by the American Geriatrics Society (AGS) for healthcare professionals to help improve the safety of prescribing medications for adults 65 years and older in all except palliative settings.
Comprehensive medication management (CMM) is the process of delivering clinical services aimed at ensuring a patient's medications (including prescribed, over-the-counter, vitamins, supplements and alternative) are individually assessed to determine that they have an appropriate reason for use, are efficacious for treating their respective medical condition or helping meet defined patient or ...