Suboptimal Dosing Parameters as Possible Factors in the Negative Phase III Clinical Trials of Progesterone for Traumatic Brain Injury

Journal of Neurotrauma

Volumn 34, Issue 11, 2017, Pages 1915-1918

  Howard, Randy B ^a   Sayeed, Iqbal ^b   Stein, Donald G ^b  

^a EMORY UNIVERSITY   (United States)

^b EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

allometric scaling; Phase III trials; progesterone; suboptimal dosing

Indexed keywords

PROGESTERONE; GESTAGEN; NEUROPROTECTIVE AGENT;

DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRUG EFFICACY; DRUG SAFETY; HUMAN; MEDICAL DECISION MAKING; NONHUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW; STUDY DESIGN; TRAUMATIC BRAIN INJURY; TREATMENT DURATION; ANIMAL; GLASGOW COMA SCALE; PROCEDURES;

ANIMALS; BRAIN INJURIES, TRAUMATIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; GLASGOW COMA SCALE; HUMANS; NEUROPROTECTIVE AGENTS; PROGESTERONE; PROGESTINS;

EID: 85019917201     PISSN: 08977151     EISSN: 15579042     Source Type: Journal    
DOI: 10.1089/neu.2015.4179     Document Type: Review

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