Non-clinical safety assessment and toxicokinetics of voriconazole and anidulafungin in the juvenile rat: A combination study design in support of a Paediatric Investigation Plan

Regulatory Toxicology and Pharmacology

Volumn 63, Issue 1, 2012, Pages 29-39

  Cross, David M ^a   Chmielewski, Gary ^b   Lewis, Elise M ^c   Liu, Lei ^b   Modesitt, Michael S ^d   Ripp, Sharon L ^b   Sawaryn, Christopher M ^b   Bowman, Christopher J ^b  

^a PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^b PFIZER INC   (United States)

^c CHARLES RIVER LABORATORIES   (United States)

^d Pharmaceutical Product Development   (United States)

Author keywords

Anidulafungin; Bioanalysis; Combination toxicity study; Juvenile rat toxicology; Paediatric Investigation Plan; Paediatric safety assessment; Sexual maturity; Toxicokinetics; Voriconazole

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ANIDULAFUNGIN; ASPARTATE AMINOTRANSFERASE; GAMMA GLUTAMYLTRANSFERASE; PF 03910960; UK 109 496; UNCLASSIFIED DRUG; VORICONAZOLE;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALBUMIN BLOOD LEVEL; ANIMAL EXPERIMENT; ANIMAL MODEL; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD CHEMISTRY; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG EXPOSURE; DRUG MEGADOSE; DRUG POTENTIATION; DRUG SAFETY; EXPERIMENTAL RAT; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEMATOLOGY; JUVENILE ANIMAL; LEUKOCYTE COUNT; LIVER WEIGHT; MALE; MAXIMUM PLASMA CONCENTRATION; NONHUMAN; PRIORITY JOURNAL; RAT; SEXUAL MATURITY; TIME TO MAXIMUM PLASMA CONCENTRATION; TOXICOKINETICS; WEIGHT REDUCTION;

ADMINISTRATION, ORAL; ANIMALS; ANTIFUNGAL AGENTS; AREA UNDER CURVE; DRUG COMBINATIONS; DRUG EVALUATION, PRECLINICAL; ECHINOCANDINS; FEMALE; INJECTIONS, SUBCUTANEOUS; MALE; PYRIMIDINES; RATS; RATS, INBRED F344; RESEARCH DESIGN; SEX FACTORS; TOXICITY TESTS; TRIAZOLES;

RATTUS;

EID: 84862797514     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.02.004     Document Type: Article

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