Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen.

Literature data are reviewed on the properties of ibuprofen related to the biopharmaceutics classification system (BCS). Ibuprofen was assessed to be a BCS class II drug. Differences in composition and/or manufacturing procedures were reported to have an effect on the rate, but not the extent of absorption; such differences are likely to be detectable by comparative in vitro dissolution tests. Also in view of its therapeutic use, its wide therapeutic index and uncomplicated pharmacokinetic properties, a biowaiver for immediate release (IR) ibuprofen solid oral drug products is scientifically justified, provided that the test product contains only those excipients reported in this paper in their usual amounts, the dosage form is rapidly dissolving (85% in 30 min or less) in buffer pH 6.8 and the test product also exhibits similar dissolution profiles to the reference product in buffer pH 1.2, 4.5, and 6.8.

[Prognosis of cancer mortality in West Germany 1976-2070]. / Prognose der Krebsmortalität in der Bundesrepublik Deutschland 1976-2070.

PIP: Estimates of future trends in cancer mortality in the Federal Republic of Germany are presented up to the year 2070. The authors describe changes that will occur as a result of demographic trends and suggest that cancer mortality will remain relatively constant at a level corresponding to about 20 percent of all causes of death. (summary in ENG)^ieng

[Prospective development of cancer mortality in the German Federal Republic (author's transl)]. / Voraussichtliche Entwicklung der Krebssterblichkeit in der Bundesrepublik Deutschland.

The absolute number of cancer deaths in males will rise considerably up to the year 2070 from about 76,000 per year in 1976 to an estimated 92,000 in 2070. The numbers will then fall to an extent which is dependent on the future birth rate. The absolute number of cancer deaths among females will remain at the present level until about the third decade of the next millenium and then fall variably depending on the development of the birth rate. The expected increase in cancer deaths among males with a rate of increase of up to 20% (!) is explained by the incipient change in the age structure of the German population alone and needs no reference to carcinogens in our environment.

[Laryngeal cancer: data on prognosis. Comparative analysis of 1128 cases in Berlin and Würzberg]. / Das Larynxkarzinom: Daten zur Prognose. Vergleichende Auswertung von 1128 Beobachtungen in Berlin und Würzburg.

The object of this survey concerning 710 patients in Berlin and 418 patients in Wuerzburg/FRG with carcinoma of the larynx is to determine the prognostic factors which are important for the results and the choice of the treatment.

[Radiotherapy of esophageal cancer -- any improvement in prognosis? (author's transl)]. / Ist die Prognose des bestrahlten Oesophaguscarcinoms gebessert worden?

Results of radiotherapy (42 MeV-Beta-tron) on 93 patients with esophageal cancer treated between 1969 and 1976 are reported and compared with those in the literature (on orthovoltage- and telecobalt-therapy). Complete remissions occured in 29%; the one -- and two-year-survival-rate for all 93 patients was 38% and 24% respectively, and for patients with complete remission 74% and 44% respectively. Although there was improvement in complete remission and short term survival compared to that reported in the literature, the five-year-survival-rate (only about 5% of patients) showed no significant improvement.

[Demineralisation of bone in chronic arterial insufficiency (author's transl)]. / Mineralsalzverlust im Skelett bei arteriellen Durchblutungsstörungen.

125I-nuclide-absorption measurement demonstrated a statistically significant decrease in mineral content of the calcaneus in 44 patients with arteriographically proven arterial occlusive disease of the lower limbs. The loss of mineral content was dependent on the clinical degree of the vascular disorder (stages according to Fontaine's classification) and the site of the arterial occlusion. There was no demonstrable relationship between the degree of demineralisation and the duration of the vascular disorder. If treatment proved successful there was a significant rise in the mineral content of the calcaneus.

[Extension of thoracic roentgen diagnosis by computer tomography (author's transl)]. / Erweiterung der Röntgendiagnostik im Thoraxbereich durch die Computer-Tomographie.

In 400 examinations of the thorax results of computer tomography were compared with respective pa chest films and conbentional tomograms. In the peripheral areas of the lung, interstitial parenchymal alterations and metastases were better visualized by CT. The size of central bronchial carcinomas and space-occupying lesions of the thoracic wall can be determined with greater accuracy by CT. Primary tumors, lymphnode enlargement and vascular alterations can be differentiated and localized more precisely by CT. The size of the heart chambers, intracavitary tumors as well as septal and myocardial wall thickness can be determined non invasively.

[Quantitative mineral estimations in vertebral bodies by computer tomography (author's transl)]. / Quantitative Mineralsalzbestimmung im Wirbelkörper mittels Computertomographie.

The accuracy of computer tomographic bone density measurements in the axial skeleton was tested by comparing results obtained from the first lumbar body in abdominal phantoms. An almost linear relationship (r = 0.998) was found between increasing concentrations of a calcium chloride solution and CT absorption values. The sum of the CT values of sections through the vertebral body correlated well with their ash content (r = 0.90) as well as with the hydroxyl apatite values obtained by I125-absorption densitometry (r = 0.88). Reproducibility of CT measurements on the phantom was good (coefficient of variation = 1.2% in the spongiosa). Average CT values of separate measurements of the spongiosa and cortex could be correlated with the total spongiosa by a special programme (r = 0.95). In the practical application of this technique, possible sources of error must be considered, such as the effect of high energy polychromatic radiation, inhomogeneity of the object being investigated and difficulties in positioning the patients

Measurement of lung density by computed tomography.

Computed tomography scanners can be calibrated to provide reproducible measurements for a quantitative analysis of lung density. Typical histograms for inspiration and expiration are presented. The reproducibility of the method is demonstrated as well as the limitations caused by artifacts and incomplete inspiration. This method is suggested for follow-up studies of patients with diseases affecting the entire lung. Early detection of interstitial lung disorders also seems possible.

[Whole body computer tomography: principle-purpose - requirements (author's transl)]. / Ganzkörper-Computer-Tomographie: Prinzip, Zweck, Bedarf.

After explaining the principle of whole body computer tomography the field of indication is outlined with reference to some of our own experiences. Up to now, it has proved its value in the following indications: preoperative diagnosis, supplementing pulmonary radiodiagnosis, substitution of invasive diagnostic procedures in mediastinal diseases, clarification of diseases of the abdominal cavity, of space-occupying processes in the kidney, in the true pelvis, and detection of retroperitoneal processes. The financial expenditure for this novel method of investigation is described according to a formula. The cost of given or estimated numerical values show the importance of adequate usage. The added costs for a second personnel shift for an examination rate of more than 7 patients a day are trivial because of the high basic expenditure.