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Health technology assessment. Health technology assessment ( HTA) is a multidisciplinary process that uses systematic and explicit methods to evaluate the properties and effects of a health technology. [1] Health technology is conceived as any intervention ( test, device, medicine, vaccine, procedure, program) at any point in its lifecycle ...
A health assessment is a plan of care that identifies the specific needs of a person and how those needs will be addressed by the healthcare system or skilled nursing facility. Health assessment is the evaluation of the health status by performing a physical exam after taking a health history. It is done to detect diseases early in people that ...
The International Classification of Diseases, Clinical Modification (ICD-9-CM) was an adaptation created by the US National Center for Health Statistics (NCHS) and used in assigning diagnostic and procedure codes associated with inpatient, outpatient, and physician office utilization in the United States. The ICD-9-CM is based on the ICD-9 but ...
Definition. A health risk assessment (HRA) is a health questionnaire, used to provide individuals with an evaluation of their health risks and quality of life. [5] Commonly a HRA incorporates three key elements – an extended questionnaire, a risk calculation or score, and some form of feedback, i.e. face-to-face with a health advisor or an ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Safety pharmacology is a branch of pharmacology specialising in detecting and investigating potential undesirable pharmacodynamic effects of new chemical entities (NCEs) on physiological functions in relation to exposure in the therapeutic range and above. [1] Primary organ systems (so-called core battery systems) are: Secondary organ systems ...
New Drug Application. The Food and Drug Administration 's (FDA) New Drug Application ( NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. [ 1][ 2] Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug ...
Certificate of pharmaceutical product. The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in ...