statistical analysis planの例文

• In response, VaxGen has issued a statement that its analysis " followed a statistical analysis plan that was agreed on in advance with the U . S . Food and Drug Administration " and that the results " remain accurate as stated, and the analysis continues ."
• CFS can severely impair patients ability to conduct their normal lives . " In October 2007 Hemispherx BioPharma submitted their first New Drug Application ( NDA ) to the FDA for rintatolimod to treat CFS . In December 2007 the agency deemed the application incomplete, citing deficiencies including lack of dose ranging, statistical analysis plans inconsistent with protocols, database discrepancies, and lack of clinical pharmacology and carcinogenicity data.