| OCR Text |
Show PMX-1061 Page 10 of 13 determined by the data base (i.e., presence or absence of 100% response, number of partial responses, etc.). The NOEC and LOEC will be defined statistically using conventional statistical procedures such as Dunnett's multiple comparisons test or a Steel's many-one rank test, depending on the data distribution. 5. 5.1 QUALITY ASSURANCE/QUALITY CONTROL Quality Assurance Program Plan Quality assurance for this study will be undertaken in accordance with the Laboratory's Quality Assurance Program Plan (QAPP). Accordingly, this test will be conducted as specified in the test protocol and the applicable Standard Operating Procedures (SOPs). 5.2 Test Acceptability Criteria 5.2.1 Biological Criteria The test will be considered acceptable, from a biological criteria standpoint, if survival in the control growth is at least 2.0 x HP cells/mL and has < 20% variation. 5.2.3 Analytical Chemistry Criteria The test will be considered acceptable, from an analytical chemistry criteria standpoint, if the mean precision for each test concentration, as measured by the coefficient of variation, is less than 40%, and if the detection limit achieved is at least one-third of the lowest concentration tested, excluding control groups. 5.3 Protocol Amendments/Deviations In the event that modifications to this protocol are deemed necessary in advance of the work's execution, a formal protocol amendment will be prepared and submitted to the Test Sponsor for authorization. The signed changes will be appended to the protocol and included with the final report. \ Should a problem develop while the study is in progress and it is not possible to obtain advance concurrence from the Test Sponsor, Parametrix may be forced to deviate from the protocol in order to maintain the test integrity. Protocol deviations will be recorded in writing at the time of deviation and signed by the Study Director. The Test Sponsor will be notified in writing the nature of the corrective actions taken, and whether the deviation is deviation, concerning |
