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The need to implement quality standards in drug research, development and testing; the situation in developing countries and the role of WHO/TDR. The testing laboratory itself or in the community as a whole. However, GLP could result in tangible returns through the number of studies placed with research organisations in DECs, resulting in an overall increase in funding. It is clear that as funding is scarce sponsors will not invest in studies if the reliability of results cannot be assured. Specifically, WHO/TDR will be reluctant to allocate their limited funding to non-clinical safety studies unless the results can be reliable on and thus support decisions concerning the progress of products to clinical stages and eventually to product registration. ¿ ... the non-clinical safety testing of test items contained in pharmaceutical products ... required by regulations for the purpose of registering or licensing ...The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health and/or the environment.¿ (OECD Principles of GLP).
| Autorius: | Vivek Dave, Amita Tilak, Sarvesh Paliwal, |
| Leidėjas: | LAP LAMBERT Academic Publishing |
| Išleidimo metai: | 2011 |
| Knygos puslapių skaičius: | 204 |
| ISBN-10: | 3845444134 |
| ISBN-13: | 9783845444130 |
| Formatas: | 220 x 150 x 13 mm. Knyga minkštu viršeliu |
| Kalba: | Anglų |
Parašykite atsiliepimą apie „Hand book of Pharmaceutical Equipment and GLP(Good Laboratory Practice): Good Laboratory Practice and Pharmaceutical Equipment“
