scholarly journals In Vitro ‐to‐ In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018

2020 ◽  
Vol 13 (4) ◽  
pp. 693-699
Author(s):  
Jingjing Yu ◽  
Isabelle Ragueneau‐Majlessi
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
The Us ◽  
Inhibition Data ◽  
In Vivo Extrapolation

scholarly journals Protein-Based Multiplex Assays: Mock Presubmissions to the US Food and Drug Administration

2010 ◽  
Vol 56 (2) ◽  
pp. 165-171 ◽  
Author(s):  
Fred E Regnier ◽  
Steven J Skates ◽  
Mehdi Mesri ◽  
Henry Rodriguez ◽  
Živana Težak ◽  
...  
Keyword(s):  
Drug Administration ◽  
Task Force ◽  
Food And Drug Administration ◽  
Protein Quantification ◽  
Diagnostic Device ◽  
Multiplex Assays ◽  
Array Platform ◽  
The Us ◽  
In Vitro Diagnostic

Abstract As a part of ongoing efforts of the NCI-FDA Interagency Oncology Task Force subcommittee on molecular diagnostics, members of the Clinical Proteomic Technology Assessment for Cancer program of the National Cancer Institute have submitted 2 protein-based multiplex assay descriptions to the Office of In Vitro Diagnostic Device Evaluation and Safety, US Food and Drug Administration. The objective was to evaluate the analytical measurement criteria and studies needed to validate protein-based multiplex assays. Each submission described a different protein-based platform: a multiplex immunoaffinity mass spectrometry platform for protein quantification, and an immunological array platform quantifying glycoprotein isoforms. Submissions provided a mutually beneficial way for members of the proteomics and regulatory communities to identify the analytical issues that the field should address when developing protein-based multiplex clinical assays.

scholarly journals ROLE OF IVERMECTIN IN THE TREATMENT OF COVID 19

2021 ◽  
Vol 9 (10) ◽  
pp. 701-702
Author(s):  
Dindi Sandhya Rani ◽  
◽  
Chinta Indu Radha ◽  
Vajrala Supriya ◽  
Anumolu Sai Sivani ◽  
...  
Keyword(s):  
Placebo Group ◽  
Severe Acute Respiratory Syndrome ◽  
Sore Throat ◽  
Drug Administration ◽  
Clinical Symptoms ◽  
Food And Drug Administration ◽  
Ivermectin Treatment ◽  
The Us

In vitro, ivermectin, an anti-parasitic drug licenced by the US Food and Drug Administration, was found to limit the replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).The three groups had similar clinical symptoms of fever, cough, and sore throat. When compared to the placebo group, virological clearance was faster in the 5-day ivermectin treatment arm (9.7 days vs 12.7 days p = 0.02), but not in the ivermectin Plus doxycycline arm (11.5 days p = 0.27). In the research, there were no serious adverse medication reactions. Adult patients with mild COVID-19 were treated with a 5-day course of ivermectin, which was proven to be both safe and efficacious. To corroborate these early findings, larger trials will be required.

Quantitative In Vitro-to-In Vivo Extrapolation: Nominal versus Freely Dissolved Concentration

2021 ◽  
Vol 34 (4) ◽  
pp. 1175-1182
Author(s):  
Luise Henneberger ◽  
Julia Huchthausen ◽  
Niklas Wojtysiak ◽  
Beate I. Escher
Keyword(s):  
Freely Dissolved Concentration ◽  
In Vivo Extrapolation
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