In the course of its work, the Expert Committee used certain terms with the meanings given below:

Benefit/risk ratio

The ratio of benefit to risk in the use of a drug; a means of expressing a judgement concerning the role of the drug in the practice of medicine, based on efficacy and safety data along with consideration of misuse potential, severity and prognosis of the disease, etc. The concept may be applied to a single drug or in comparisons between two or more drugs used for the same condition.

Bioavailability

The rate and extent of absorption of a drug from a dosage form as determined by its concentration/time curve in the systemic circulation or by its excretion in urine.

Compliance

Faithful adherence by the patient to the prescriber’s instructions.

Dosage form

The form of the completed pharmaceutical product, e.g. tablet, capsule, elixir, suppository.

Drug

Any substance in a pharmaceutical product that is used to modify or explore physiological systems or pathological states for the benefit of the recipient.

Drug formulation

The composition of a dosage form, including the characteristics of its raw materials and the operations required to process it.

Drug utilization

The marketing, distribution, prescription and use of drugs in a society, with special emphasis on the resulting medical, social and economic consequences.

Efficacy

The ability of a drug to produce the purported effect as determined by scientific methods.

Excipient

Any component of a finished dosage form other than the claimed therapeutic ingredient or ingredients.

Pharmaceutical product

Synonymous with dosage form.

Pharmacokinetics

The study of the rate of drug action, particularly with respect to:

- the variation of drug concentrations in tissues with time, and

- the absorption, distribution, metabolism and excretion of drugs and metabolites.