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MedDRA
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation. Also, it is the adverse event classification dictionary. The first version of MedDRA was released in 1999 in English and Japanese. MedDRA is now translated into Chinese, Czech, Dutch, French, German, Hungarian, Italian, Korean, Portuguese, Brazilian Portuguese, Russian, and Spanish. In MedDRA version 25.0, Swedish and Latvian translations were also added. In many countries/regions the use of Med ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Council For Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s the European Union began harmonising regulatory requirem ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
SNOMED CT
SNOMED CT or SNOMED Clinical Terms is a systematically organized computer-processable collection of medical terms providing codes, terms, synonyms and definitions used in clinical documentation and reporting. SNOMED CT is considered to be the most comprehensive, multilingual clinical healthcare terminology in the world. The primary purpose of SNOMED CT is to encode the meanings that are used in health information and to support the effective clinical recording of data with the aim of improving patient care. SNOMED CT provides the core general terminology for electronic health records. SNOMED CT comprehensive coverage includes: clinical findings, symptoms, diagnoses, procedures, body structures, organisms and other etiologies, substances, pharmaceuticals, devices and specimens. SNOMED CT is maintained and distributed by SNOMED International, an international non-profit standards development organization, located in London, UK. SNOMED International is the trading name of the Inte ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Drug Safety
Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: (Greek for drug) and (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an advers ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: (Greek for drug) and (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse ev ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: (Greek for drug) and (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse ev ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Classification Of Diseases
The International Classification of Diseases (ICD) is a globally used diagnostic tool for epidemiology, health management and clinical purposes. The ICD is maintained by the World Health Organization (WHO), which is the directing and coordinating authority for health within the United Nations System. The ICD is originally designed as a health care classification system, providing a system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. This system is designed to map health conditions to corresponding generic categories together with specific variations, assigning for these a designated code, up to six characters long. Thus, major categories are designed to include a set of similar diseases. The ICD is published by the WHO and used worldwide for morbidity and mortality statistics, reimbursement systems, and automated ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
WHOART
The WHO Adverse Reactions Terminology (WHOART) is a dictionary meant to serve as a basis for rational coding of adverse reaction terms. The system is maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug Monitoring. The system is no longer actively maintained. Structure * 32 System-organ classesbody organ groups * 180 High level terms for grouping Preferred terms * 2085 Preferred terms principal terms for describing adverse reactions * 3445 Included terms synonyms to Preferred terms See also * Pharmacovigilance *COSTART *MedDRA *Adverse event An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ... References WHO Adverse Reactions Terminology Medical classification Pharmacological classification systems {{tre ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Systematized Nomenclature Of Medicine
The Systematized Nomenclature of Medicine (SNOMED) is a systematic, computer-processable collection of medical terms, in human and veterinary medicine, to provide codes, terms, synonyms and definitions which cover anatomy, diseases, findings, procedures, microorganisms, substances, etc. It allows a consistent way to index, store, retrieve, and aggregate medical data across specialties and sites of care. Although now international, SNOMED was started in the U.S. by the College of American Pathologists (CAP) in 1973 and revised into the 1990s. In 2002 CAP's SNOMED Reference Terminology (SNOMED RT) was merged with, and expanded by, the National Health Service's Clinical Terms Version 3 (previously known as the Read codes) to produce SNOMED CT. Versions of SNOMED released prior to 2001 were based on a multiaxial, hierarchical classification system. As in any such system, a disease may be located in a body organ (anatomy), which results in a code in a topography axis and may lead ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
COSTART
The Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) was developed by the United States Food and Drug Administration (FDA) for the coding, filing and retrieving of post-marketing adverse reaction reports. COSTART provides a method to deal with the variation in vocabulary used by those who submit adverse event reports to the FDA. Use of this dictionary allowed for standardization of adverse reaction reporting towards the FDA in a consistent way. COSTART was last updated in 1999. It has been replaced by the Medical Dictionary for Regulatory Activities, MedDRA. See also * Pharmacovigilance * WHOART * Adverse event An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ... References External links COSTART lookup {{treatment-stub Pharmacological classification systems< ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tobacco
Tobacco is the common name of several plants in the genus '' Nicotiana'' of the family Solanaceae, and the general term for any product prepared from the cured leaves of these plants. More than 70 species of tobacco are known, but the chief commercial crop is ''N. tabacum''. The more potent variant ''N. rustica'' is also used in some countries. Dried tobacco leaves are mainly used for smoking in cigarettes and cigars, as well as pipes and shishas. They can also be consumed as snuff, chewing tobacco, dipping tobacco, and snus. Tobacco contains the highly addictive stimulant alkaloid nicotine as well as harmala alkaloids. Tobacco use is a cause or risk factor for many deadly diseases, especially those affecting the heart, liver, and lungs, as well as many cancers. In 2008, the World Health Organization named tobacco use as the world's single greatest preventable cause of death. Etymology The English word ''tobacco'' originates from the Spanish word "tabaco ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory Authority
A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government agency, government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulation, regulating capacity. These are customarily set up to strengthen safety and standards, and/or to protect consumers in markets where there is a Imperfect competition, lack of effective competition. Examples of regulatory agencies that enforce standards include the Food and Drug Administration in the United States and the Medicines and Healthcare products Regulatory Agency in the United Kingdom; and, in the case of Regulatory economics, economic regulation, the Office of Gas and Electricity Markets and the Telecom Regulatory Authority of India, Telecom Regulatory Authority in India. Legislative basis Regulatory agencies are generally a part of the executive (government), executive branch of the government and have stat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Thesaurus (information Retrieval)
In the context of information retrieval, a thesaurus (plural: "thesauri") is a form of controlled vocabulary that seeks to dictate semantic manifestations of metadata in the indexing of content objects. A thesaurus serves to minimise semantic ambiguity by ensuring uniformity and consistency in the storage and retrieval of the manifestations of content objects. ANSI/NISO Z39.19-2005 defines a content object as "any item that is to be described for inclusion in an information retrieval system, website, or other source of information". The thesaurus aids the assignment of preferred terms to convey semantic metadata associated with the content object. A thesaurus serves to guide both an indexer and a searcher in selecting the same preferred term or combination of preferred terms to represent a given subject. ISO 25964, the international standard for information retrieval thesauri, defines a thesaurus as a “controlled and structured vocabulary in which concepts are represented by terms ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
