220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

20caccachexia def. unintended and progressive weight loss that is often accompaniedby weakness, fever, nutritional deficiencies, diarrhea,and usually with a disproportionate muscle wasting. It occurs inmany chronic illnesses and diseases such as cancer, in particularadvanced stage cancer, but also Alzheimer’s disease, chronic heartfailure, chronic lung disease, congestive heart failure, cystic fibrosis,Crohn’s disease, renal failure, rheumatoid arthritis, tuberculosis,liver cirrhosis, heart surgery, sepsis and sarcopenia; there is nouniversally accepted definition but the 95% CIs for change in bodyweight in healthy adults is ±2% in 1 month and ±5% in 6 months;→ see weight.calibration EC (IV): “the set of operations which establish, underspecified conditions, the relationship between values indicatedby a measuring instrument or measuring system, or values representedby a material measure, and the corresponding known valuesof a reference standard”.CAMA Computer assisted marketing authorisation (Europe), wherebythe information on the new drug is submitted in electronicform; → see canda.CANDA Computer assisted new drug application (US), whereby theinformation on the new drug is submitted in electronic form, e.g.on optical disks of WORM-type (write once, read many); no universalrecommendations exist at the time being; → see also damos.CAPA → see corrective and preventive actions.Capability Maturity Model (CMM) According to the “Capability MaturityModel” there are five maturity levels: (1) Initial: The softwareprocess is characterised as ad hoc, and occasionally even chaotic;few processes are defined, and success depends on individual effortand heroics. (2) Repeatable: Basic project management processesare established to track cost, schedule, and functionality; thenecessary process discipline is in place to repeat earlier successeson projects with similar applications. (3) Defined: The softwareprocess for both management and engineering activities is documented,standardised and integrated into a standard softwareprocess for the organisation; all projects use an approved, tailoredversion of the organisation’s standard software process for developingand maintaining software. (4) Managed: Detailed measuresof the software process and product quality are collected; both thesoftware process and products are quantitatively understood andcontrolled. (5) Optimising: Continuous process improvement isenabled by quantitative feedback from the process and from pilotinginnovative ideas and technologies.CAPLA Computer assisted product license application; → see canda.