Responsibilities of PI, Regulatory requirements, GCP expectations, Ethical obligations

STAVZOR DOSING

Stavzor (generic : valproic acid ) is a delayed release medication for the treatment of seizure , manic episodes and migraine headaches (Kinze et al , 2001 . This drug is manufactured in capsule format in concentrations of 125 , 250 and 500 mg . Clinical trials have shown that Stavzor of up to 60 mg /kg /day is safe for administration hence a dosing schedule should be established using the available concentrations to assure the patient of safety and prevent the patient from complications such as toxicity . Since Stavzor can be administered to different indications

, appropriate dosing schedules may be followed based on the target population

In the case of manic episodes for patients positively diagnosed with bipolar dis , the patient can be prescribed with 750 mg of Stavzor daily , in portioned concentrations and then suddenly increasing the dose to the lowest concentration that reaches the optimal plasma concentration . In the case of patients suffering from complex seizures the patient may be initially administered with Stavzor at 10 - 15 mg /kg /day . For the subsequent weeks , the dosage can be increased by 5 - 10 mg /kg /day until the optimal response is observed in the patient . It is thus important that follow-up appointments be made with the patient with weekly checkups being the ideal scenario because the increase in the dosage will be done every week . At the same time , the concentration of valproate in the patient 's blood serum should be checked for verification of the optimal dose . For patients experiencing absence seizures...