Clinical ECG assessment

To date, the most common tool for clinical assessment of cardiac electrical function is the electro-cardiogram (ECG). It is a dynamic representation, usually obtained from the body surface, of the changes in cardiac electrical behaviour. 

Regulatory guidance for non-clinical cardiovascular safety pharmacology testing is given in the ICH S7A and B.25,42 The effects of an NCE on blood pressure, heart rate, and the ECG should be evaluated. Furthermore, in vivo, in vitro, and ex vivo evaluations, including methods for (assessing) repolarization and conductance abnormalities, should... 

In clinical investigation proper assessment of the effectiveness of homeopathic potencies should be made. For this, adequate placebo controls should be maintained, and modem diagnostic procedures such as blood chemistry, X-ray, ultrasonography, CT scan, MRI, ECG, EEG etc. should be adopted. Results with clinical investigation may show marked individual variation simply because of miasms. We would discuss about miasms in Chapter IV. 

Monitor for clinical efficacy and toxicity. Warn patients to report t drowsiness, malaise and anorexia. Measure amylase and lipase if toxicity is suspected. Tramadol causes less respiratory depression than other opiates, but need to monitor BP and blood counts and advise patients to report wheezing, loss of appetite and fainting attacks. Need to consider reducing dose. Methadone may cause Q-T prolongation the CSM has recommended that patients with heart and liver disease on methadone should be carefully monitored for heart conduction abnormalities such as Q-T prolongation on ECG, which may lead to sudden death. Also need to monitor patients on more than 100 mg methadone daily, and thus t plasma concentrations necessitates close monitoring of cardiac and respiratory function 2. Recommended that a small test dose (one-quarter of the usual dose) be administered initially to assess response... 

How safe is the new drug Evaluations include clinical laboratory tests, physical assessments, vital signs, adverse events, and cardiac effects through electrophysiological monitoring via an ECG. 

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