Drug samples

Table 10.3 presents for each country, for the period 1994-97, the number of drug samples submitted for testing, samples tested and the failure rate in those tests. Data are available from all 10 countries on the total number of samples submitted and the number of samples tested, and these show that seven countries— Australia, Cypms, Estonia, Malaysia, the Netherlands, Venezuela and Zimbabwe — have been able to meet the demand for testing (92-100%). Uganda has a relatively low test rate of 56% for the submitted samples, followed by Cuba and Tunisia at 72% and 88%, respectively. The lack of certain equipment and materials, such as reference standards and reagents, constrains analysis in Cuba, Cyprus, Uganda and Zimbabwe. 

Figure 10.3 Percentage of drug samples tested and failed during 1994-97 ...

In a similar diffusional device, the ointment containing the drug sample was placed on a membrane over a stirred and thermostated receptor fluid [23], Potential advantages of this device are that the unit construction fixes the distance between the stirrer and the membrane and the stirrer symmetry relative to the membrane is less susceptible to variation. This device was used to evaluate the... 

Infrared spectra of known and newly reported compounds are provided in the British Pharmacopoeia (1998) and also in Sadtler Standard Spectra published by Sadder Research Laboratories, Philadelphia (USA) is available to check the authenticity of pure drug samples. 

Services (HHS) and spells out research, enforcement, and education requirements. The Prescription Drug Marketing Act prevents the resale of diverted drugs, requires drug wholesalers be licensed, restricts reimportation, and bans the sale, trade, or purchase of drug samples or counterfeit drug coupons. 

The National Institute for the Control of Pharmaceutical Biological Products (NICPBP) performs tests on the drug samples submitted. Based on the test results and the report from the CDE, the DDR approves the conduct of clinical trials at designated hospitals in China (Fig. 8.13). 

ESI LC/MS has been shown to be effective in measuring A,A/-dimethylaminoethyl chloride as its related dimethylaziridinium species in drug samples [22]. 

The Prescription Drug Marketing Act of 1987 includes civil penalties for violation of the drug sample provisions of the FD C Act. The law provides that a manufacturer or distributor who violates these provisions is subject to a civil penalty of not more than 50 000 for each of the first two violations resulting in a conviction in any 10-year period, and for not more than 1 million for each violation resulting in a conviction after the second conviction in any 10-year period. These penalties may be imposed only by a Federal District Court. FDA has no administrative authority to impose any civil penalties imder these provisions. 

The law first specifies that a drug manufactured in the United States and exported to another country cannot be imported back into the United States (unless done so by the original manufacturer or required for emergency medical care). The law next specifies that no person may sell, purchase, or trade or offer to sell, purchase, or trade any drug sample (that is, any drug given out for promotion rather than intended for sale). Representatives of drug manufacturers and distributors also cannot sell samples and must keep records of the samples they distribute to health care practitioners. 

Physicians codes, guidelines and policies on receiving gifts and drug samples... 

As outlined above, some professional organizations are more specific than others. However, the general theme appears to be that while minor gifts, entertainment, and drug samples should not be solicited they may be acceptable if they directly promote better patient care or indirectly promote education or research and, in either case, do not affect the integrity of the physician-patient relationship. 

With respect to drug samples, the only marketing practice stated is that samples, clearly identified as such, may be supplied to the prescribing professions to familiarize them with products, to enable them to gain experience with the product in their practice, or upon request. 

Directly coupled HPLC-NMR spectroscopy has been used in a number of other studies of chemical impurities. An impurity in a bulk drug sample of the glycinamide ribonucleotide transformylase inhibitor AG2034, shown below ... 

Figure 10 HPLC chromatogram (top) and CE electropherogram (bottom) obtained on a partially degraded drug sample. Peaks A,A and B,B are difficult to separate, diastereomeric pairs.

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