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Quantify Depression Clinical Outcomes Database

The Quantify Major Depression Disorder (MDD) Clinical Outcomes Database documents clinical efficacy and safety information from randomized and controlled regulatory trials investigating monotherapy and adjunctive therapy pharmaceutical drugs for major depression disorder and treatment-resistant depression.

Synchrogenix ClinGenuity Redaction Management Solution (CRMS)

Synchrogenix’s unique AI engine, has created an engine that is built on natural language processing and recognition. Because of the power behind our unique AI, the engine can be configured to identify PPD and CCI the same way an individual would be trained on these definitions. The process of identifying and redacting sensitive information becomes automated and significantly more accurate.

Learning from Failure: Leveraging Biosimulation for Pediatric Drug Development Success

The high rate of trial failures, increasing regulatory demands, and ethical imperatives all require a reexamination of the current approach to pediatric drug development. Biosimulation is a proven approach that will help optimize trial design and inform the drug label. This approach can support global regulatory strategies that increase the likelihood of success for pediatric drug development programs.

Pharmacokinetic Profile of Defibrotide in Patients with Renal Impairment

Hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome (VOD/SOS), is an unpredictable, potentially life-threatening complication of hematopoietic stem cell transplant conditioning. Severe VOD/SOS, generally associated with multiorgan dysfunction (pulmonary or renal dysfunction), may be associated with >80% mortality. Defibrotide, recently approved in the US, has demonstrated efficacy treating hepatic VOD/SOS with multiorgan dysfunction. Because renal … Continued

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