Relative Bioavailability of Two Drug Products of Somatropin Obtained from Either the Milk of Transgenic Cows or Bacterial Culture

2010 ◽  
Vol 73 (4) ◽  
pp. 258-264 ◽  
Author(s):  
J. Farías ◽  
E. Feleder ◽  
E. González ◽  
K. Halabe ◽  
M.E. Criscuolo ◽  
...  
2021 ◽  
Vol 23 (3) ◽  
Author(s):  
Gopal Pawar ◽  
Fang Wu ◽  
Liang Zhao ◽  
Lanyan Fang ◽  
Gilbert J. Burckart ◽  
...  

AbstractGenerally, bioequivalence (BE) studies of drug products for pediatric patients are conducted in adults due to ethical reasons. Given the lack of direct BE assessment in pediatric populations, the aim of this work is to develop a database of BE and relative bioavailability (relative BA) studies conducted in pediatric populations and to enable the identification of risk factors associated with certain drug substances or products that may lead to failed BE or different pharmacokinetic (PK) parameters in relative BA studies in pediatrics. A literature search from 1965 to 2020 was conducted in PubMed, Cochrane Library, and Google Scholar to identify BE studies conducted in pediatric populations and relative BA studies conducted in pediatric populations. Overall, 79 studies covering 37 active pharmaceutical ingredients (APIs) were included in the database: 4 bioequivalence studies with data that passed BE evaluations; 2 studies showed bioinequivalence results; 34 relative BA studies showing comparable PK parameters, and 39 relative BA studies showing differences in PK parameters between test and reference products. Based on the above studies, common putative risk factors associated with differences in relative bioavailability (DRBA) in pediatric populations include age-related absorption effects, high inter-individual variability, and poor study design. A database containing 79 clinical studies on BE or relative BA in pediatrics has been developed. Putative risk factors associated with DRBA in pediatric populations are summarized.


1985 ◽  
Vol 24 (02) ◽  
pp. 101-105
Author(s):  
C. S. Brown ◽  
S. I. Allen ◽  
D. C. Songco

SummaryA computer-assisted system designed to write drug prescriptions and patient instructions has been in operation in a dermatologist’s office for two years. Almost all prescriptions are generated by the machine. Drug dosages, directions, and labeling phrases are retrieved from a diagnosis-oriented formulary of 300 drug products. A prescription template with preselected default options is displayed on a terminal screen where selection is made with the use of the video pointer. Typing skill is not required, as a detailed prescription can be produced from the use of only five function keys. Prescriptions and sets of relevant instructions for the patient are computer-printed. Therapy summaries for the medical record also are automatically composed and printed.


Author(s):  
Ahmad Almehmadi

Abstract The re-use of healing abutments (HAs) has become common practice in implant dentistry for economic concerns and the aim of this in-vitro study was to assess the effect of sodium hypochlorite (NaOCl) in decontamination of HAs. 122 HAs (Used and sterilized n=107; New n=15) were procured from 3 centers, of which 3 samples were discarded due to perforation in sterilization pouch.  For sterility assessment, the used HAs (n=80) were cultured in Brain Heart Infusion Broth (BHI) and Potato Dextrose Agar (PDA), bacterial isolates were identified in 7 samples. Also, 24 used HAs were stained with Phloxine B, photographed and compared to new HAs (n=5). Scanning electron microscope (SEM) assessed the differences between the two sets of HAs, following which the 7 contaminated HAs along with 24 used HAs from staining experiment (Total=31) were subsequently treated with sodium hypochlorite (NaOCl) and SEM images were observed. About 8.75% of HAs tested positive in bacterial culture; Streptococcus sanguis, Dermabacter hominis, Staphylococcus haemolyticus, and Aspergillus species were isolated. Phloxine B staining was positive for used and sterilized HAs when compared to controls. The SEM images revealed deposits in the used HAs and although treatment with NaOCl eliminated the contamination of cultured HAs, the SEM showed visible debris in the HA thread region. This in-vitro study concluded that SEM images showed debris in used HAs at screw-hole and thread regions even though they tested negative in bacterial culture. The treatment with NaOCl of used HAs showed no bacterial contamination but the debris was observed in SEM images. Future studies on the chemical composition, biological implications, and clinical influence is warranted before considering the reuse of HAs.


2020 ◽  
Vol 4 (2) ◽  
pp. 58-69 ◽  
Author(s):  
Patricia Fajardo-Cavazos ◽  
Wayne L. Nicholson

AbstractThe NASA GeneLab Data System (GLDS) was recently developed to facilitate cross-experiment comparisons in order to understand the response of microorganisms to the human spaceflight environment. However, prior spaceflight experiments have been conducted using a wide variety of different hardware, media, culture conditions, and procedures. Such confounding factors could potentially mask true differences in gene expression between spaceflight and ground control samples. In an attempt to mitigate such confounding factors, we describe here the development of a standardized set of hardware, media, and protocols for liquid cultivation of microbes in Biological Research in Canisters (BRIC) spaceflight hardware, using the model bacteria Bacillus subtilis strain 168 and Staphylococcus aureus strain UAMS-1 as examples.


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