General patient management products

Current pharmacotherapies are targeted to decrease the production of aqueous humor at the ciliary body and to increase outflow through the trabecular meshwork and uveoscleral pathways. There is no consensus on the best lOP-lowering technique for glaucoma therapy. General principles of patient management based on the patient s health, age, and ocular status include ... 

The individual responsiveness to desmopressin is consistent, and a test dose administered at the time of diagnosis or prior to therapy is the best predictor of response. Generally, DDAVP is more effective in vWD than in hemophilia patients, with an average 30% to 50% increase in vWF and factor VIII levels. In patients with an adequate response, desmopressin is first-line therapy because it allows for once-daily administration (elevates plasma levels for 8-10 hours), does not pose a threat in terms of viral transmission, and the cost is substantially less than that of the plasma-derived products. Fibrinolysis inhibitors (50-60 mg/kg of aminocapriotic acid every 4—6 hours or trenex-amic acid 10-15 mg/kg every 8-12 hours) and OCs are used successfully in the management of epistaxis and menorrhagia or as adjuvant treatments. 

At the same time, several types of data necessary to ensure proper management of occupational risks associated with a drug substance are not generally useful in evaluating potential patient risks. So the necessary tests—eye and skin irritation, sensitization and inhalation toxicity, as well as assessment of the hazards of byproducts and impurities that do not get incorporated into the final therapeutic product—are not performed in the normal course of development. 

Process improvements may be conducted by the completion of a task or a project. A task is an activity that can be completed by the process owner with minimal cost and/or resources over a short period of time. A project is defined as temporary work to provide a product or service that is beyond the process owner s support. In general, a project requires more than one full-time equivalent (FTE), crosses over multiple functional organizations, and the duration of the effort spans over a longer period of time. Improvement status, updates, and issues should be discussed on a regular basis by a management forum or steering committee. Tasks and projects should be prioritized based on the risk against patient safety and efficacy and compliance. 

There are no specific blood or urine tests for phosphine itself. Breakdown products of phosphine can be measured in urine, but the result of this test is generally not useful in the clinical management of patients. 

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