Complex Drug Substances

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There are many drug substances that may fit into the category of "Complex Drug Substances." These include many proteins, peptides, botanicals, synthetic hormones, biotechnology products, and complex mixtures. For most of these drugs, the most difficult problem is to demonstrate

FIGURE 5 Unlike endogenous substances such as hormones which are synthesized by the body, endogenous potassium arises solely from dietary sources. The body transports potassium from place to place and excretes excess amounts primarily into the urine. Thus, a patient deficient in potassium will utilize supplemental potassium, whereas normal volunteers ingesting adequate levels of potassium will excrete virtually all, if any, excess. Because homeostatic mechanisms maintain blood potassium levels within a narrow range, there is very little change in blood levels following a potassium dose. This means that following a dose of potassium, a high percentage of the resulting potassium blood levels is due to the baseline that was already present before dosing. As a result, blood is not a good site for sampling for bioequivalence studies of oral dosage forms delivering potassium. Since most of an ingested dose is excreted in urine, bioequivalence is documented by measuring amounts of potassium excreted in urine. Urinary data must still be corrected for baseline, but this baseline represents a much smaller percentage of the total excreted.

FIGURE 5 Unlike endogenous substances such as hormones which are synthesized by the body, endogenous potassium arises solely from dietary sources. The body transports potassium from place to place and excretes excess amounts primarily into the urine. Thus, a patient deficient in potassium will utilize supplemental potassium, whereas normal volunteers ingesting adequate levels of potassium will excrete virtually all, if any, excess. Because homeostatic mechanisms maintain blood potassium levels within a narrow range, there is very little change in blood levels following a potassium dose. This means that following a dose of potassium, a high percentage of the resulting potassium blood levels is due to the baseline that was already present before dosing. As a result, blood is not a good site for sampling for bioequivalence studies of oral dosage forms delivering potassium. Since most of an ingested dose is excreted in urine, bioequivalence is documented by measuring amounts of potassium excreted in urine. Urinary data must still be corrected for baseline, but this baseline represents a much smaller percentage of the total excreted.

pharmaceutical equivalence, i.e., that the drug substances are actually the same within each manufacturer's dosage form. In many cases, current technology is not sufficient to unequivocally characterize the drug substance in two different manufacturer's products or after a single manufacturer wishes to make pre or postapproval changes in manufacturing procedures. These challenges in drug substance characterization methods currently may stand in the way of the approval of generic products for many of these products containing complex drug substances.

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