Clinical stability

Patients may be initiated on amphotericin B and changed to oral itraconazole 200-400 mg orally daily once patient is clinically stabilized and a minimum dose of 500 mg of amphotericin B has been administered. 

Amphotericin B 0.7-1 Patients without CNS infection may be switched to itracon-mg/kg/day IV (total azole once clinically stabilized and a minimum dose of... 

Unstable angina/Non-Q-wave Ml - The recommended dose is 120 units/kg of body weight (but not more than 10,000 units) subcutaneously every 12 hours with concurrent oral aspirin (75 to 165 mg/day) therapy. Concurrent aspirin therapy is recommended except when contraindicated. Continue treatment until the patient is clinically stabilized. The usual duration of treatment is 5 to 8 days. 

Supervised consumption in the pharmacy for at least the first three months with relaxation only on clinical stability (i.e. no illicit drug use). 

Some combination of two or more of the negative symptoms listed above have been present for the preceding 12 months and always were present during periods of clinical stability (including chronic psychotic states). These symptoms may or may not be detectable during transient episodes of acute psychotic disorganization or decompensation... 

An independent cross-sectional survey, not sponsored by the pharmaceutical industry, in schizophrenic outpatients clinically stabilized on a neuroleptic drug for a period of 6 months showed that quality-of-life measures and Global Assessment of Functioning did not differ significantly in patients taking typical neuroleptic drugs (n = 44) and novel ones (risperidone, n = 50 olanzapine, n = 48 quetia-pine, n = 42 clozapine, n = 46) (42). 

The optimal duration of therapy for febrile neutropenia is controversial. The decision to discontinue antimicrobials is based on resolution of neutropenia, defervescence, culture results, and clinical stability of the patient. 

Occurrence of acute renal failure from P-lactam treatment may be prevented by early treatment of serious infections, together with maintenance of hemodynamic stability, renal perfusion, and urinary solute excretion. The P-lactam induced renal failure has a time course comparable to acute tubular necrosis of other origins. While there is no firm evidence that dialysis will speed up renal recovery, clinical stability and good nutrition are likely to improve recovery, as it is also the case with other types of renal failure. 

Process development history—K brief discussion of the development of the synthetic process may be expected in the marketing applications. This section allows the company to establish the bridge from the synthesis used to manufacture early development safety samples, clinical materials, pivotal clinical/stability batches, and API for commercial product. This bridge is particularly valuable for reviewers in the more sophisticated markets who may not have previously reviewed the processes contained in the investigational applications. Again, the level of detail provided for this section will vary considerably. 

Wetstone HJ, LaMotta RV. The clinical stability of serum cholinesterase activity. Clin Chem. 1965 11 653-663. 

Branch TP, Siebold R, Freedberg HI, Jacobs CA (2011) Double-bundle ACL reconstruction demonstrated superior clinical stability to single-bundle ACL reconstruction a matched-pairs analysis of instrumented tests of tibial anterior translation and internal rotation laxity. Knee Surg Sports Traumatol Arthrosc 19 432-440... 

Patients requiring PMV account for a disproportionate amount of health care costs and resources, with those who are ventilator dependent in the ICU for >21 days accounting for 37% of all ICU costs (29). Therefore, there has been a significant drive to improve outcomes and to increase non-ICU facilities, where such patients can receive appropriate care. The decision to transfer a patient who requires PMV may be difficult. Clinical stability and a determination that the patient s staffing needs will be met are necessary before transfer to a step-down unit. A noninvasive respiratory care unit is less expensive than an ICU, allows for more effective transition home or to a nonacute care location, fosters patient independence, and improves quality of life (Fig. 1). 

In this case, patient refusal to tolerate NIPPY eventually resulted in invasive ventilation. Serial follow-up studies confirmed clinical stability and a leak around her tracheostomy tube were addressed by increasing her cuff volume. 

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