From Laboratory Bench to Registration and Marketing Approval

2013 ◽  
pp. 594-618
Author(s):  
Rita Dobmeyer ◽  
Flavio De Rosa
Keyword(s):  
Marketing Approval ◽  
Laboratory Bench

scholarly journals Environmental fate and effects assessment of human pharmaceuticals: lessons learnt from regulatory data

2021 ◽  
Vol 33 (1) ◽  
Author(s):  
Simon Schwarz ◽  
Daniela Gildemeister ◽  
Arne Hein ◽  
Patrick Schröder ◽  
Jean Bachmann
Keyword(s):  
Environmental Fate ◽  
Environmental Risks ◽  
Marketing Approval ◽  
Current Guideline ◽  
The European Union ◽  
Medicinal Products ◽  
Effect Data ◽  
Assessment Approach ◽  
Biotic Degradation ◽  
High Sorption

AbstractHuman pharmaceuticals are extensively studied and assessed before marketing approval. Since 2006, this also includes an assessment of environmental risks. In the European Union, this is based on the guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 corr 2), which is currently under revision. For Germany, the German Environment Agency (UBA) is tasked with the evaluation of environmental risks of human pharmaceuticals. Applicants seeking approval of medicinal products need to submit fate and effect data, in case predicted environmental concentrations (PECs) exceed 10 ng/L in surface waters, or the substance is of specific concern through its mode of action or physico-chemical characteristics.Over the last decade, this regulatory work resulted in an internal agency database containing effect data on approximately 300 active pharmaceutical ingredients (APIs). A considerable part of this data is currently not publicly available due to property rights held by the respective applicants. The database was evaluated to draw conclusions on how the current assessment approach may be improved.The evaluation of aquatic effect data shows considerable variation in ecotoxic effect concentrations, but supports the current use of 10 ng/L as PEC action limit. For endocrine-active substances and antibiotics, a clear sensitivity profile was observed, which allows a more targeted assessment in the future. The conclusions drawn from terrestrial effect data are less clear, as the database itself is biased because information is only available for substances with high sorption. Further adaptations of the terrestrial assessment strategy, including action triggers, appear necessary. Fate data show a high persistence of many APIs: approximately 43% of all APIs are classified as very persistent; 12% of these show DT50 values in a range where abiotic or biotic degradation is not expected.Overall, the evaluation has shown that improvements of the current guideline are possible.

scholarly journals Sulfaquinoxaline Oxidation and Toxicity Reduction by Photo-Fenton Process

2021 ◽  
Vol 18 (3) ◽  
pp. 1005
Author(s):  
Vanessa Ribeiro Urbano ◽  
Milena Guedes Maniero ◽  
José Roberto Guimarães ◽  
Luis J. del Valle ◽  
Montserrat Pérez-Moya
Keyword(s):  
Escherichia Coli ◽  
Staphylococcus Aureus ◽  
Pilot Plant ◽  
Environmental Water ◽  
Fenton Process ◽  
Experimental Conditions ◽  
Laboratory Bench ◽  
Degradation Rates ◽  
Bacterial Growth Inhibition ◽  
And Staphylococcus Aureus

Sulfaquinoxaline (SQX) has been detected in environmental water samples, where its side effects are still unknown. To the best of our knowledge, its oxidation by Fenton and photo-Fenton processes has not been previously reported. In this study, SQX oxidation, mineralization, and toxicity (Escherichia coli and Staphylococcus aureus bacteria) were evaluated at two different setups: laboratory bench (2 L) and pilot plant (15 L). The experimental design was used to assess the influence of the presence or absence of radiation source, as well as different H2O2 concentrations (94.1 to 261.9 mg L−1). The experimental conditions of both setups were: SQX = 25 mg L−1, Fe(II) = 10 mg L−1, pH 2.8 ± 0.1. Fenton and photo-Fenton were suitable for SQX oxidation and experiments resulted in higher SQX mineralization than reported in the literature. For both setups, the best process was the photo-Fenton (178.0 mg L−1 H2O2), for which over 90% of SQX was removed, over 50% mineralization, and bacterial growth inhibition less than 13%. In both set-ups, the presence or absence of radiation was equally important for sulfaquinoxaline oxidation; however, the degradation rates at the pilot plant were between two to four times higher than the obtained at the laboratory bench.

Body parts from the laboratory bench

2005 ◽  
Vol 92 (4) ◽  
pp. 385-386
Author(s):  
G. Kratz
Keyword(s):  
Body Parts ◽  
Laboratory Bench

scholarly journals Moving from the Laboratory Bench to Patients’ Bedside: Considerations for Effective Therapy with Stem Cells

2011 ◽  
Vol 4 (5) ◽  
pp. 380-386 ◽  
Author(s):  
Lauren S. Sherman ◽  
Jessian Munoz ◽  
Shyam A. Patel ◽  
Meneka A. Dave ◽  
Ilani Paige ◽  
...  
Keyword(s):  
Stem Cells ◽  
Effective Therapy ◽  
Laboratory Bench

Heavy metal contaminant remediation study of western Xiamen Bay sediment, China: Laboratory bench scale testing results

2009 ◽  
Vol 172 (1) ◽  
pp. 108-116 ◽  
Author(s):  
Luoping Zhang ◽  
Huan Feng ◽  
Xiaoxia Li ◽  
Xin Ye ◽  
Youhai Jing ◽  
...  
Keyword(s):  
Heavy Metal ◽  
Xiamen Bay ◽  
Bench Scale ◽  
Laboratory Bench ◽  
Contaminant Remediation ◽  
Metal Contaminant
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