ABSTRACT
La OMS tiene el mandato constitucional de "desarrollar, establecer y promover normas internacionales con respecto a productos [alimenticios,] biológicos, farmacéuticos y similares". En este sentido, colabora estrechamente con los comités de nomenclatura nacionales para seleccionar una sola denominación aceptable en todo el mundo para cada sustancia activa destinada a la venta como producto farmaceútico. Para evitar confusiones que pudieran poner en peligro la seguridad de los pacientes, las marcas registradas no deben derivarse de las denominaciones comunes internacionales (DCI) ni tener ninguno de los radicales comunes empleados en dichas denominaciones. Los avances recientes en investigaciones farmacológicas y en biotecnología plantean dificultades para el comité de nomenclatura. Se están organizando nuevos esquemas y conceptos para la denominación, por ejemplo, de los anticuerpos monoclonales y otros compuestos recombinantes
Subject(s)
International Nonproprietary Names for Pharmaceutical Substances , Drug and Narcotic Control/legislation & jurisprudence , Legislation, Pharmacy/standards , Drugs, GenericABSTRACT
WHO has a constitutional mandate to "develop, establish and promote international standards with respect to biological, pharmaceutical and similar products". The Organization collaborates closely with national nomenclature committees to select a single name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical. To avoid confusion, which could jeopardize the safety of patients, trade-marks should neither be derived from INNs nor contain common stems used in INNs. Recent developments in pharmacological research and biotechnology are challenges for the nomenclature committee. New schemes and concepts are being developed, for example, for naming monoclonal antibodies and other recombinant compounds.
Subject(s)
Drugs, Generic , Terminology as Topic , International CooperationABSTRACT
La OMS tiene el mandato constitucional de "desarrollar, establecer y promover normas internacionales con respecto a productos [alimenticios,] biológicos, farmacéuticos y similares". En este sentido, colabora estrechamente con los comités de nomenclatura nacionales para seleccionar una sola denominación aceptable en todo el mundo para cada sustancia activa destinada a la venta como producto farmaceútico. Para evitar confusiones que pudieran poner en peligro la seguridad de los pacientes, las marcas registradas no deben derivarse de las denominaciones comunes internacionales (DCI) ni tener ninguno de los radicales comunes empleados en dichas denominaciones. Los avances recientes en investigaciones farmacológicas y en biotecnología plantean dificultades para el comité de nomenclatura. Se están organizando nuevos esquemas y conceptos para la denominación, por ejemplo, de los anticuerpos monoclonales y otros compuestos recombinantes
Publicado en inglés en el Bull. WHO. Vol. 73(3):275-79, 1995
Subject(s)
International Nonproprietary Names for Pharmaceutical Substances , Legislation, Pharmacy , Drug and Narcotic Control , Drugs, GenericABSTRACT
Noninvasive 24h BP monitoring using portable devices is a new method for the diagnosis of arterial hypertension and for the control of antihypertensive therapy in adults. Recently, it is also used in juvenile hypertension. We now report on the validity and reliability of an oscillometric BP recorder (SpaceLabs 90207) widely used in children and adolescents. Single BP recordings with this monitor were compared with manual auscultation of Korotkoff sounds and with measurements by an other oscillometric device (Dinamap). SBP measured by the SpaceLabs monitor was 5 mmHg (2-10 mmHg, median and quartiles) higher than manual readings whereas there was no difference in DBP between these methods. With the Dinamap monitor, SBP was identical to manual readings but DBP was underestimated by 8.5 mmHg (1-13 mmHg). The 24h BP monitoring was performed in 101 children < 13 years of age and in 58 adolescents > 12 years of age. Seventy-eight per cent (64-89%) of all readings were complete in the younger probands and 91% (84-95%) in the older ones (P < 0.01). Measurements failed more often during daytime compared with nighttime in both groups. In conclusion, long-term BP monitoring using an oscillometric device is useful and reliable in adolescents and even in smaller children.
Subject(s)
Blood Pressure Monitors , Blood Pressure , Circadian Rhythm , Oscillometry/instrumentation , Adolescent , Adult , Child , Child, Preschool , Diastole , Evaluation Studies as Topic , Female , Humans , Infant , Male , SystoleSubject(s)
Absorptiometry, Photon , Body Composition , Adipose Tissue/anatomy & histology , Adipose Tissue/chemistry , Adolescent , Adult , Arm , Body Weight , Bone Density , Energy Intake , Humans , Leg , Male , Military Personnel , Muscles/anatomy & histology , Muscles/chemistry , Physical Education and Training , Weight Loss/physiologyABSTRACT
It is important to remember that: 1. WHO is an international organization representing 182 member countries. 2. WHO has a constitutional mandate inter alia to "develop, establish and promote international standards with respect to biological, pharmaceutical and similar products." 3. Its present programme covers such activities as WHO Good Manufacturing Practices, the International Pharmacopoeia, International Nonproprietary Names (INN), WHO Certification Scheme, the Model List of Essential Drugs and many other subjects concerning safety, efficacy and quality. 4. Emphasis is now directed to the feasibility of further harmonization of requirements for drug registration and quality control having regard to the number of countries with increasing manufacturing facilities.
Subject(s)
Drug Industry/standards , World Health Organization , Certification , Forecasting , Pharmacopoeias as Topic , Quality ControlABSTRACT
Blood pressure was continuously monitored over 24 h in 33 healthy children and adolescents (18 girls, 15 boys, age 6-17 years) using a portable monitor. The results were compared with European blood pressure centiles for normal children and adolescents. On average, 67% (57-88%, median and quartiles) of the measurements were completed. The day's mean for systolic blood pressure for girls was 0.04 (-0.67-1.00) standard deviations above the mean of the reference group with corresponding body-height, and for diastolic blood pressure, 1.08 (0.50-1.63) standard deviations. The corresponding values for boys were 0.42 (0.09-0.45) for systolic and 1.11 (1.00-1.39) for diastolic blood pressure. Mean systolic blood pressure for girls decreased during the night by 10% (5-13%) compared to the day time measurements, and the diastolic blood pressure decreased overnight by 23% (12-28%). Systolic blood pressure for boys decreased overnight by 8% (6-11.5%), and diastolic blood pressure decreased by 15% (12-19%).
