Benefit–Risk Determinations at the FDA Center for Devices and Radiological Health

2017 ◽  
pp. 53-67
Author(s):  
Telba Irony ◽  
Martin Ho
Keyword(s):  
Radiological Health

scholarly journals Nebulizer – In vitro Bioequivalence testing requirements: A review

1970 ◽  
Vol 8 (1) ◽  
pp. 78-81
Author(s):  
Shubham Prajapati ◽  
Sanjay Saha ◽  
B Shambulingappa ◽  
Dilip Kumar Ch. ◽  
Bikash Sahoo
Keyword(s):  
United States ◽  
Size Distribution ◽  
United States Of America ◽  
Droplet Size Distribution ◽  
The United States ◽  
Drug Substance ◽  
Regulatory Agencies ◽  
Metered Dose ◽  
Radiological Health

Generic Nebulized aerosol is often perceived as inferior to their branded counterparts; however, they are safe and effective if they can meet the regulatory requirements. International regulatory agencies have developed recommendations and guidance for bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The objective of this article is to discuss the approaches can be used for to show bioequivalence requirement for Food and Drug Administration (FDA) in the United States of America (USA) with reference product. This review endorsed that inhalation solutions and suspensions undertaken to determine the drug substance delivery rate, total drug substance delivered and Aerodynamic assessment of nebulized aerosols [aerodynamic particle size distribution (APSD)/droplet size distribution (DSD)].These are the most important parameters in characterization, evaluation and bioequivalence studies of nebulizers. These devices operate continuously; once loaded and require little or no co-ordination on the part of user they proved that these devices suitable for weak, pediatric or geriatric patients. The regulatory agencies declared that; there is no specific requirements testing in case of nebulizers like Metered dose inhalers (MDI) and Dry powder inhalers (DPIs). In United States of America (USA) regulation falls under the auspices of centre for devices and radiological health (CDRH), and new devices require 510(k) premarket notification. This review outlines all the bioequivalence test parameter.  

scholarly journals Radiological Health Aspects of Oil Well Logging

1966 ◽  
Vol 81 (12) ◽  
pp. 1064 ◽  
Author(s):  
Norman Geiger ◽  
Raymond T. Moore
Keyword(s):  
Well Logging ◽  
Oil Well ◽  
Radiological Health

Determination of Natural Radioactivity and Radiological Hazard Associated with Sediments Sourced from Ogunpa River Channels, Ibadan, Nigeria

2021 ◽  
Author(s):  
N N Jibiri ◽  
S O Egwu ◽  
N E Adesiji
Keyword(s):  
Building Material ◽  
Natural Radionuclides ◽  
Water Channel ◽  
River Channels ◽  
Activity Concentrations ◽  
Soils And Sediments ◽  
Radium Equivalent ◽  
Radiological Safety ◽  
Radiological Health

Abstract The natural radionuclides content and radiological assessment of sediments of the Ogunpa waste-water channel were evaluated to ascertain the radiological safety of the sediments as a building material. The mean activity concentrations of 40K, 226Ra and 232Th in Bq kg−1 were found to be 171 ± 69, 11 ± 5 and 10 ± 4, respectively. The overall mean radium equivalent 29 ± 13 Bq kg−1 was <370 Bq kg−1 that can give the maximum recommended dose of 1 mSv to the general public. The activity concentrations of the radionuclides were all less than world average for soils and sediments. Thus, the use of the sediments from the Ogunpa water channel as building material is safe and would not pose any significant radiological health hazards.

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