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In contrast, the G-BA did not request pharmacology data, which was covered by 8 PAMs.
Pharmacology: data on drug-drug interactions, pharmacokinetics, pharmacodynamics, dosing or dose timing.
The importance of this discipline has been achieved by increasing its translational value, based on the recognition of biological target drug molecule adverse drug reaction (ADR) associations and integration of secondary pharmacology data with pharmacokinetic parameters.
The workflow queries across open data sources by means of the Open PHACTS Discovery Platform, and consists of the following steps: The "Target Pharmacology: List" API call was used to retrieve pharmacology data from ChEMBL for the protein targets under study by including a filter for the "activity_types" (activity endpoints) "IC50", "EC50", and "Ki", as well as for the "activity_unit" "nanomolar".
These investigations provide the essential information required for the selection of a safe starting dose and escalation for FIH trials based on toxicology and pharmacology data and the minimal anticipated biological effect level (MABEL) by integrating all available in vivo and in vitro data.
Kinetic (in vitro, pharmacokinetic, mass balance and toxicokinetic studies) and safety pharmacology data available in 34 Investigator's Brochures used to support First-In-Man clinical trials over a 10 year period have been evaluated to give an insight into the types of study designs used and how these have changed over the period analysed (1997 2006).
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In conclusion, these model-based analyses proved an efficient and effective way to synthesize complex, confounded clinical pharmacology information from early clinical data of LY2878735, thus helping elucidate the relative positioning of LY2878735 in the class of SNRIs with regard to relative SERT/NET potency, target engagement, and cardiovascular and drug interaction liabilities.
The trout plasma concentrations at these effective aqueous concentrations fell within the range of mammalian effective plasma concentrations, supporting the potential for developing 'read-across' from mammalian pharmacology safety data to fish ecotoxicology.
Systems pharmacology combines data from clinical observation and molecular biology.
This review summarizes the clinical pharmacology and data for this new agent.
Somnolence has been reported with exenatide treatment post-approval [ 1] and had an incidence of 1% in the three registration trials of exenatide in combination with oral anti-diabetic therapy (30 weeks each) and up to 6% in other studies of exenatide [including short-term (28 days), uncontrolled and clinical pharmacology studies; data not shown].
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