Generic drugs measurement

The measurement of the bioavailability and bioequivalence of drug dosage forms is commonplace. The numerous reasons for the increased use of such studies include rapid growth of the generic drug industry an increased awareness of the effect of dosage form on the rate and extent of drug absorption the development of more sensitive and reliable analytic methods to... 

As implied by the few examples above, generic drug policies can be effectively implemented through a mix of measures influencing both supply and demand. On the supply side this may involve introducing and implementing ... 

Generic drug policies can only be effective if the regulatory policy is appropriate, if doctors, pharmacists and patients fully understand, endorse and embrace the concept, and if positive incentives and rewards are provided. The simple fact that in many countries pharmacists are, as noted above, now permitted to substitute the prescribed brand product by the generic has substantially increased the use of the latter. Overall measures aimed at increasing information and transparency in the market should provide... 

In an article by Nerukar et al. [18] of the U.S. Office of Generic Drugs, published in 1992, it was mentioned that current FDA policy does not require the measurement of individual enantiomers to demonstrate bioequivalence. They indicated that they agreed in principle that because the pharmacodynamics of the enantiomers of a racemic drug may differ, generic applicants should measure each enantiomer to satisfy the bioequivalence requirements. They also stated, the office does not wish to impose a requirement for enantiospecific assays in the absence of compelling reasons to do so. Criteria for the compelling reasons were not specified in detail. 

Each series has a set of keywords that specify the series properties. The database can be searched by author name, citation, compound name, SMILES or keywords. A search of a substructure or a generic pattern is also possible. The pattern of molecules in a series is highlighted. Compounds in most series include the same or parent structures with different functional groups. Many series also include existing drugs or other lead compounds. A possible correlation can be derived between the structure and the measured bioactivity. 

The medication costs in this study are for branded Lovastatin and generic niacin. For niacin, the cost was taken to be Medicaid s reimbursement for multiple-source drugs. The actual measure was slightly below the average wholesale price but was above the lowest wholesale prices quoted. For Lovastatin, costs were estimated using the 1994 average wholesale price. 

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