Drug safety category

Drugs are classihed into several categories. These are synthetic drugs, TCM, and biological products. The SFDA stipulates compliance to GMP for medical products, GCP for clinical trials, and GLP for nonclinical drug safety research. 

Uhl K, Kennedy DL, Kweder SL. 2002. Risk management strategies in the Physicians Desk Reference product labels for pregnancy category X drugs . Drug Safety 25 885-892. 

The sulfonamides are used with caution in patients with renal or hepatic impairment and bronchial asthma. These drugs are given with caution to patients with allergies. Safety for use during pregnancy has not been established (Pregnancy Category C, except at term). 

The nurse should use cephalosporins cautiously in patients with renal or hepatic impairment and in patients with bleeding disorders. Safety of cephalosporin administration has not been established in pregnancy or lactation these drugs are assigned to Pregnancy Category B. 

This drug is contraindicated in patients with known hypersensitivity to die drug and during die first trimester of pregnancy (Category B). This drug is used cautiously in patients widi blood dyscrasias, seizure disorders, and hepatic dysfunction. Safety in children (odier dian orally for amebiasis) lias not been established. 

Misoprostol is used cautiously in women of childbearing age. Mesalamine, olsalazine, sucralfate, and sulfasalazine are Pregnancy Category B drugs all are used with caution during pregnancy (safety has not been established) and lactation. 

The primary objective of a Phase I trial is to assess the safety of the drug in humans. Studies are normally conducted in healthy male volunteers, although specific categories of subject may be used in certain cases. For example, to avoid the risk of low blood pressure, subjects with mild hypertension would be more appropriate for the evaluation of antihypertensive drugs, while patients are likely to be used in the case of drugs that are expected to produce significant toxic effects (e.g. anti-cancer cytotoxic drugs). Remuneration may be offered for participation in the study. The number of subjects is normally between 10 and 100 people. 

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