Clinical investigation of neuraxially administered drugs: A regulatory perspective

Anesthesia and Analgesia

Volumn 109, Issue 2, 2009, Pages 299-300

  Schultheis, Lex W ^a   Nikhar, Bindi M ^a   Mellon, R Daniel ^a   Doddapaneni, Suresh ^a   Christodoulo, Danae D ^a   Roca, Rigoberto ^a   Rappaport, Bob A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANESTHETIC AGENT; BUPIVACAINE; CHOLINESTERASE INHIBITOR; LOCAL ANESTHETIC AGENT; NEOSTIGMINE;

ANALGESIA; CAUDA EQUINA SYNDROME; CLINICAL PHARMACOLOGY; CLINICAL PROTOCOL; DRUG EXPOSURE; DRUG MANUFACTURE; DRUG SAFETY; EPIDURAL ANESTHESIA; GRANULOMA; HUMAN; NEURAXIAL ANALGESIA; NEUROLOGIC DISEASE; NONHUMAN; OBSTETRIC ANALGESIA; PATIENT CONTROLLED ANALGESIA; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; TOXICOLOGY; ADULT; CHEMISTRY; DRUG LEGISLATION; FEMALE; NOTE; PREGNANCY; UNITED STATES;

ADULT; ANALGESIA, EPIDURAL; ANALGESIA, OBSTETRICAL; ANESTHETICS, LOCAL; BUPIVACAINE; CHOLINESTERASE INHIBITORS; FEMALE; HUMANS; LEGISLATION, DRUG; NEOSTIGMINE; PREGNANCY; UNITED STATES;

EID: 67849092551     PISSN: 00032999     EISSN: None     Source Type: Journal    
DOI: 10.1213/ane.0b013e3181a801b9     Document Type: Editorial

References (2)

1. Ross VH, Pan PH, Owen MD, Seid MH, Harris L, Clyne B, Voltaire M, Eisenach JC. Neostigmine decreases bupivacaine use by patient-controlled epidural analgesia during labor: a randomized controlled study. Anesth Analg 2009;109:524-531
2. Food and Drug Administration (FDA, USA). Code of Federal Regulations 21 CFR § part 58: good laboratory practice for nonclinical laboratory studies. Available at: www.fda.gov. Accessed February 25, 2008