NIH National Institute of Child Health and Human Development (A0009) - Clinical Study Report

This Other document was issued by the Food and Drug Administration (FDA)

For related information, Open Docket Folder   Docket folder icon


Attachments

  ( 15 )

R_1 Meropenem Metadata Rpt

View Attachment:
Authors: CDER
 

R_2 Meropenem Annotated CRF

View Attachment:
Authors: CDER
 

R_3 Model Dev Val_MBPCA PK Raw Dataset 004_part-1

View Attachment:
Authors: CDER
 

R_3 Model Dev Val_MBPCA PK Raw Dataset 004_part-2

View Attachment:
Authors: CDER
 

R_3 Model Dev Val_MBPCA PK Scavanged Dataset 004_part-1

View Attachment:
Authors: CDER
 

R_3 Model Dev Val_MBPCA PK Scavanged Dataset 004_part-2

View Attachment:
Authors: CDER
 

R_4 MBPCA_Define

View Attachment:
Authors: CDER
 

R_5 MBPCA_Text Control Output

View Attachment:
Authors: CDER
 

R_6 Exposure Resp Dataset_PD Output

View Attachment:
Authors: CDER
 

R_7 Cum Distr Exposures_MBPCA COMBO TBL

View Attachment:
Authors: CDER
 

R_7 Cum Distr Exposures_MBPCA Figures

View Attachment:
Authors: CDER
 

R_8 Assay Method Validation Memo

View Attachment:
Authors: CDER
 

R_8 Assay Method Validation Summary Rpt

View Attachment:
Authors: CDER
 

R_9 Presentations Publications_10-23-11dp edits

View Attachment:
Authors: CDER
 

 
 
ID: FDA-2011-N-0918-0006

Comments

0
Comments Received *

* The total reflects comments received from Regulations.gov and other means as of 11:59 PM yesterday. All comments received may not be posted at this time including bulk submissions; therefore, the total comments received and posted may differ.