Biopharmaceutics Considerations In New Drug Development

Biopharmaceutics is a comprehensive term denoting the study of the influence of pharmaceutical formulation variables on the performance of the drug in vivo [5]. In a new drug application, the OCPB reviewer generally looks for the pH solubility profile, pKa of the drug substance, drug permeability or octanol/water partition coefficient measurement which may be useful in selecting the dissolution methodology and specifications.

Dissolution of the drug under physiological conditions is one of the factors assessing drug absorption after oral administration. Dissolution testing is required for all solid oral dosage forms in which absorption of the drug is necessary for the product to exert the desired therapeutic effect. In addition to predicting in vivo performance of the dosage units, dissolution tests help in assuring drug product quality from batch to batch and may also be a guide in the development of new formulations. The dissolution specifications set forth also ensure the drug product's sameness under scaleup and postapproval changes. Dissolution data also provides for assessing the waiver of a bioequivalence study. For NDAs the dissolution

TABLE 2 Summary of Clinical Pharmacology and Biopharmaceutics Characteristic of the Drug

Drug Name:_Indication_Dosage Form

Dose:_Dosage Regimen_

co 2

TABLE 2 Summary of Clinical Pharmacology and Biopharmaceutics Characteristic of the Drug

Drug Name:_Indication_Dosage Form

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