Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2007-2012
Medical (PDF -21KB)
Medical (PDF -38KB)
Medical Addendum (PDF -64KB)
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Medical (PDF - 3 MB)
Statistical (PDF - 985 KB)
Clinical pharmacology (PDF -568KB)
Biopharmaeutic review (PDF -551KB)
Medical (PDF -1.8MB)
Medical (PDF -478KB)
Medical (PDF -286KB)
Clinical pharmacology (PDF -2.7MB)
Clinical pharmacology (PDF -793KB)
Medical (PDF -100KB)
Medical (PDF -2MB)
Medical (PDF -1MB)
Medical (PDF -352KB)
Clinical pharmacology (PDF -100KB)
Clinical pharmacology (PDF -100KB)
Statistical Addendum (PDF -22KB)
Medical (PDF - 538 KB)
Medical (PDF - 35 KB)
Medical (PDF - 118 KB)
Medical (PDF -315KB)
Clinical pharmacology (PDF -72KB)
Medical (PDF -24KB)
Medical (PDF -201KB)
Memo (PDF -320KB)
Clinical pharmacology (PDF -67KB)
Clinical pharmacology (PDF -225KB)
Medical (PDF -36KB)
Statistical (PDF -250KB)
Medical (PDF -40KB)
Medical (PDF -62KB)
Medical (PDF -2MB)
Medical (PDF -604KB)
BPCA Summary (PDF -76KB
Statistical Addendum (PDF -159KB)
Safety (PDF -230KB)
Safety (PDF -119KB)
Clinical pharmacology (PDF -116KB)
Clinical pharmacology (PDF -1MB)
CDTL Review (PDF -597KB)
Medical (PDF -11MB)
Medical Addendum (PDF -260KB)
Medical Addendum (PDF -700KB)
Medical (PDF -659KB)
CTDL Review (PDF -221KB)
CTDL Addendum (PDF -112KB)
DD Memo (PDF -22KB)
Statistical (PDF -381KB)
Research & Development L.L.C.
Clinical pharmacology Addendum (PDF -46KB)
Clinical pharmacology (PDF -646KB)
Medical (PDF -358KB)
Clinical pharmacology (PDF -2MB)
Medical Addendum (PDF -63KB)
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