Issue Date: January 10, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment This guidance does not discuss the general issues of statistical analysis or clinical trial design. Those topics are addressed in the ICH guidances for industry E9 Statistical Principles for Clinical Trials (September 1998) and E10 Choice of Control Group and Related Issues in Clinical Trials (May 2001), respectively.
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