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#Winnonlin computer psp
However, the presence of PSP in cell culture medium has no significant effect on OATP’s function. PSP interacts with known OATP substrates/inhibitors. The K m values for OATP1B1-, OATP1B3-, and OATP2B1-mediated PSP uptake were 11.3 ± 1.5, 7.0 ± 1.5, and 5.1 ± 1.0 μM, respectively. An in vitro cell-based study demonstrated that PSP is a substrate for OATP1B1, OATP1B3, and OATP2B1, with OATP1B3 showing the highest transport efficiency.
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In the present study, six human major hepatic uptake transporters expressed on the basolateral membrane of hepatocytes, namely, organic anion transporting polypeptide 1B1 (OATP1B1), OATP1B3, OATP2B1, Na +/taurocholate cotransporting polypeptide (NTCP), organic cation transporter 1 (OCT1), and OAT2, have been investigated to see whether they are involved in the hepatic uptake of PSP.
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However, so far, the molecular mechanism for PSP transport from the blood into hepatocytes is unclear. In biliary excretion, PSP is effluxed from hepatocytes into the bile via MRP2. The urinary excretion of PSP is mediated by organic anion transporter 1/3 (OAT1/3) and multidrug resistance protein 2 (MRP2). After administered into the body, PSP is excreted into urine and bile. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety.Phenolsulfonphthalein (PSP or phenol red), a sulfonphthalein dye, has been used as a diagnostic agent and a pH indicator in cell culture medium. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. To learn more about Phoenix WinNonlin Validation Suite 4.0, please visit: About CertaraĬertara is the global biosimulation technology-enabled drug development and drug safety consulting company. Minimizing the cost of computer system validation, by reducing the time required to complete computer system validation.
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Reducing the need for specialized PK/PD scientist participation in the computer system validation process.Ensuring that Phoenix WinNonlin functions as intended in the user’s computing environment.Key benefits realized when using Phoenix WinNonlin Validation Suite 4.0 include:
#Winnonlin computer software
“Our Validation Suite solution distills the collective knowledge and experience of Certara’s pharmacokineticists, software engineers, quality engineers, quality assurance personnel, and deployment personnel into an easy-to-use tool which facilitates the efficient execution of a Phoenix WinNonlin validation project.” “Our clients who work in a regulated environment choose to utilize the Phoenix WinNonlin Validation Suite because it allows them to streamline the validation of their Phoenix WinNonlin computer system, saving time and resources, and decreasing the total cost of ownership of the Phoenix WinNonlin software, while meeting compliance expectations,” said Certara Quality Assurance Manager Debra Fontana. Phoenix WinNonlin is part of the premier Phoenix PK/PD software platform used by more than 5,000 biopharmaceutical companies, veterinary and academic researchers, along with the FDA, PDMA, MHRA, EMA and other regulatory authorities to analyze and report toxicokinetic (TK)/pre-clinical and clinical PK/PD data. The document templates and automated scripts in Phoenix WinNonlin Validation Suite 4.0 have been updated to reflect the new functionality in Phoenix WinNonlin 6.4. The Phoenix WinNonlin Validation Suite provides document templates for use as starting points for validation process deliverables and nearly 200 automated test scripts for testing Phoenix WinNonlin functionality. Regulatory authorities expect that computer systems used in the development of drug products will be validated, to ensure that the computer system complies with the user’s requirements and functions as intended. 27, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced the launch of Phoenix WinNonlin Validation Suite 4.0 for automatic validation of the recently released Phoenix WinNonlin version 6.4. Phoenix® WinNonlin® Validation Suite™ 4.0 can help ensure compliance, reduce total cost of ownership and improve work efficiency