New EMA guideline for antimicrobial development

The Lancet Infectious Diseases

Volumn 12, Issue 4, 2012, Pages 265-266

  Ambrose, Paul G ^a,b   Bhavnani, Sujata M ^a   Dudley, Michael N ^c   Ellis Grosse, Evelyn ^d   Rubino, Christopher M ^a   Drusano, George L ^e  

^a INSTITUTE FOR CLINICAL PHARMACODYNAMICS   (United States)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c Rempex Pharmaceuticals   (United States)

^d E2g Biopharmaceutical Consulting   (United States)

^e UNIVERSITY OF FLORIDA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT;

ANTIBIOTIC RESISTANCE; ANTIMICROBIAL ACTIVITY; DRUG DEVELOPMENT; EUROPEAN MEDICINE AGENCY; GRAM NEGATIVE BACTERIUM; HEALTH CARE ORGANIZATION; IMMUNOCOMPROMISED PATIENT; LETTER; PRACTICE GUIDELINE; PRIORITY JOURNAL; TREATMENT RESPONSE;

DRUG DISCOVERY; EUROPEAN UNION; GRAM-NEGATIVE BACTERIA; GRAM-NEGATIVE BACTERIAL INFECTIONS; GUIDELINES AS TOPIC; HUMANS;

EID: 84858967884     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(12)70046-4     Document Type: Letter

References (4)

1. Bhavnani SM A call to arms. Nat Rev Drug Discov 2007, 6:12.
2. Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections European Medicines Agency, Committee for Medicinal Products for Human Use, (accessed Jan 15, 2012). http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003417.pdf.
3. Pharmacometrics at FDA US Department of Health and Human Services, Food and Drug Administration, (accessed Jan 15, 2012). http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm167032.htm#Overview.
4. Ambrose PG, Bhavnani SM, Rubino CM, et al. Pharmacokinetics-pharmacoynamics of antimicrobial therapy: it's not just for mice anymore. Clin Infect Dis 2007, 44:79-86.