Drug product determination

Obtain a thorough medication history, including use of prescription, non-prescription, and complementary and alternative drug products. Determine which, if any, treatments in the past had been helpful as judged by the patient. Could any of the patient s current medications be contributing to Ul ... 

Although in many cases an enantiopure drug can be safer than the racemate, the advantages are clear. The final formulation of the drug product could be reduced inhalf, potential side effects could be minimized, and the resulting pharmokinetic and pharmacodynamic studies could clearly determine the efficacy of the active pharmaceutical ingredient (API) [21]. 

Determination of the drug substance is expected to be enantioselective, and this may be achieved by including a chiral assay in the specification or an achiral assay together with appropriate methods of controlling the enantiomeric impurity. For a drug product where racemization does not occur during manufacture or storage, an achiral assay may suffice. If racemization does happen, then a chiral assay should be used or an achiral method combined with a validated procedure to control the presence of the other enantiomer. 

Lot number, control number, or batch number means any distinctive combination of letters, numbers, or combination of letters, numbers, or symbols, or nay combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined. 

Determination of conformance to written descriptions of sampling procedures and appropriate specifications for drug products. Such samples shall be representative and properly identified. 

Obtain a thorough history of prescription, nonprescription, and natural drug product use. Determine what treatments for cholesterol the patient has used in the past (if any). Assess if the patient is taking any medications that may contribute to his or her abnormal lipid levels. 

Perform a thorough medication history (nonprescription, prescription, and natural drug products), food, and patient history to determine exacerbating factors. 

Obtain a thorough history of nonprescription, prescription, and natural drug product use. Determine which treatments have been helpful in the past. 

Drug therapy is a dynamic process. When a drug product is administered, absorption usually proceeds over a finite time interval, and distribution, metabolism, and excretion (ADME) of the drug and its metabolites proceed continuously at various rates. The relative rates of these ADME processes determine the time course of the drug in the body, most importantly at the receptor sites that are responsible for the pharmacological action of the drug. 

To determine whether human testing for a new drug or new drug product is reasonable, it is first necessary to conduct preclinical studies and to submit the IND. The necessary information needed to prepare the IND is outlined in Table 1. The IND is to contain information on appropriate prior animal studies for safety evaluation, any available clinical data, adequate drug identification and manufacturing instructions, and a detailed outline of the proposed clinical study, routs of administration, approximate number of patients to be used, and an estimate of the length of treatment and an environmental impact statement. 

As indicated in previous sections of this chapter, there has developed a quite impressive international consensus on the general principles of bioequivalency determination for drug products regulated by agencies such as FDA. However, there are other materials used with therapeutic intent for which bioequivalency may also be a legitimate concern. Herbal remedies have, in recent years, demonstrated impressive increases in sales in many parts of the world. Other substances of natural origin have gained considerable attention for their possible curative potential. For example, shark... 

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