Ionizing radiation is used in medical examinations. It causes microscopic damage to living tissue. Radiation protection in medical radiography provides vital information on radiation protection. The general objectives of this study were to describe the measures taken for radiation protection in the x-ray rooms at the departments of radiography of selected private hospitals in the municipal area of Kandy and the specific objectives were to find out the details of room designing with relevance to radiation protection and to compare above with the standard guidelines. This was a descriptive study.Three departments of x-ray of the private hospitals of the Kandy municipal area were selected as the sample of the study. Measurements were taken by using standard measuring tape. Data collection was done in a quantitative manner. Data analysis was done by comparing the measurements which were taken in hospitals with the AEA(Atomic Energy Authority, Sri Lanka) standards. Some of the major noncompliance was: x-ray room situated in high occupancy area at Hospital 1 ,Inadequate wall thickness of the xray room at Hospital 1 and Hospital 2,Entrance door opening to the occupancy area at Hospital 1,Interlock system or warning indicator was not attached to the door at three departments,Inadequate wall thickness of the control panel at Hospital 1,Incorrect construction material of the wall of the control panel was at Hospital 1,Erect bucky fixed as primary beam directed towards the occupied area at Hospital 2 and Hospital 3,Patient waiting area is provided in front of the entrance door at Hospital 2 etc. Compatible measurements with AEA standards at the three departments of radiography under study were:Room dimension was compatible with AEA standards,Material of the wall of the x-ray room,Type of the door,Lead thickness of the door,Number of doors kept minimum as described by the AEA standards,Lead glass thickness of the control panel. Radiation protection measures taken in designing of the x-ray room and installation of the x-ray machines at the departments of radiography of private hospitals in the municipal area of Kandy revealed that some important measurements in the departments under study are incompatible with AEA standards and most of them are compatible with AEA standards. .
This post-marketing study on prednisolone products in Sri Lanka was conducted using BCS-based biowaiver procedures for performing in vitro bioequivalence studies. The market leader product with the highest availability was selected as the comparator in the absence of the innovator product. A validated UV/Visible spectrophotometric method was used to quantify the drug dissolution. Cumulative drug release profiles were determined in dissolution media at pH 1.2, 4.5, and 6.8 using the paddle apparatus. Although the two test products and the comparator met pharmacopoeial requirements for quality, they failed to meet in vitro biowaiver criteria. Acceptability of biowaiver study results depends on the performance of the comparator product. Information on the comparator product's bioequivalence to the innovator product was not available. This study revealed the difficulties in low and middle-income countries (LMICs) when conducting biowaiver studies for regulatory submission and highlights the necessity to have bioequivalence data and excipient information for the comparator product for better decision making. The study supports having an international standard comparator product used by LMICs when manufacturing and registering generic drug products.
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