Using Dynamic Lists in SAS Stored Processes for GeneticSAS使用动态列表的存储过程的遗传.pptVIP

* * * Page * ? Using Dynamic Lists ? February 9, 2011 Using Dynamic Lists in SAS Stored Processes for Genetic Toxicity Historical Control Data Volker Harm, PhUSE Conference 2011, Brighton Page * ? Using Dynamic Lists ? February 9, 2011 Agenda Example from Drug Development Importance of Genetic Toxicity Testing What are Historical Control Data? Enhanced Use of Metadata in SAS BI Using SAS with SAS Stored Processes Using Dynamic Lists in Metadata Page * ? Using Dynamic Lists ? February 9, 2011 Standardized Genetic Toxicity Testing Genetic Toxicity Testing Part of safety assessment in Phase I of drug development Mostly done on animals Required by authorities after some very serious incidents (Contergan, 1961) Standardized Based on a fixed protocol Evaluation based on sound statistical design and analysis Fixed conditions based on OECD guidelines Strictly audited by authorities Page * ? Using Dynamic Lists ? February 9, 2011 Structure of a Genetic Toxicity Test The typical structure for a genetic toxicity test is Responses of three doses of a test substance are compared to the responses of medium/solvent control to asses an effect of the substance. Responses of the positive control are compared to the responses of the medium/solvent control to asses the sensitivity of the assay. This setting may be repeated under different experimental conditions as With or without metabolic activation Pulse or continuous treatment Group Treatment Dose level 1 Medium/solvent control 2 Test substance Low dose 3 Test substance Mid dose 4 Test substance High dose 5 Positive control Page * ? Using Dynamic Lists ? February 9, 2011 Control Groups Control groups are Not treated with the substance to be tested Used to control the test system to minimize the impact of possible extraneous variables to recognize the possible presence of unwanted variables in the test system assess the sensitivity of the test system Responses seen in control groups should not vary from study to study, but