Your browser doesn't support javascript.
loading
United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts.
Oketch-Rabah, Hellen A; Roe, Amy L; Rider, Cynthia V; Bonkovsky, Herbert L; Giancaspro, Gabriel I; Navarro, Victor; Paine, Mary F; Betz, Joseph M; Marles, Robin J; Casper, Steven; Gurley, Bill; Jordan, Scott A; He, Kan; Kapoor, Mahendra P; Rao, Theertham P; Sherker, Averell H; Fontana, Robert J; Rossi, Simona; Vuppalanchi, Raj; Seeff, Leonard B; Stolz, Andrew; Ahmad, Jawad; Koh, Christopher; Serrano, Jose; Low Dog, Tieraona; Ko, Richard.
Affiliation
  • Oketch-Rabah HA; U.S. Pharmacopeial Convention, Rockville, MD, USA.
  • Roe AL; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Rider CV; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Bonkovsky HL; Vice Chair, (USP GTEH EP, 2015-2020 cycle).
  • Giancaspro GI; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Navarro V; U.S. FDA Liaison to the USP GTEH EP (2015-2020 cycle).
  • Paine MF; Section on Gastroenterology & Hepatology, Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USA.
  • Betz JM; U.S. Pharmacopeial Convention, Rockville, MD, USA.
  • Marles RJ; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Casper S; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Gurley B; Expert Members of the Drug Induced Liver Injury Network (DILIN), USA.
  • Jordan SA; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • He K; Department of Pharmaceutical Sciences, College of Pharmacy and Pharmaceutical Sciences, Washington State University, Spokane, WA, USA.
  • Kapoor MP; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Rao TP; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Sherker AH; U.S. FDA Liaison to the USP GTEH EP (2015-2020 cycle).
  • Fontana RJ; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Rossi S; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Vuppalanchi R; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Seeff LB; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Stolz A; United States Pharmacopeia Green Tea Hepatotoxicity Expert Panel (USP GTEH EP, 2015-2020 cycle), Rockville, MD, USA.
  • Ahmad J; Expert Members of the Drug Induced Liver Injury Network (DILIN), USA.
  • Koh C; Liver Diseases Research Branch National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 6707 Democracy Blvd., Bethesda, MD, USA.
  • Serrano J; Expert Members of the Drug Induced Liver Injury Network (DILIN), USA.
  • Low Dog T; Department of Internal Medicine, University of Michigan, Ann Arbor, MI, 48109, USA.
  • Ko R; Expert Members of the Drug Induced Liver Injury Network (DILIN), USA.
Toxicol Rep ; 7: 386-402, 2020.
Article in En | MEDLINE | ID: mdl-32140423
Key words
ADME, Absorption, distribution, metabolism, and excretion; ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; AUC, area under the curve; Bw, body weight; C, Catechin; CAM, causality assessment method; CG, (+)­catechin­3­gallate; CIH, Concanavalin A-induced hepatitis; CMC, chemistry, manufacturing, and controls; COMT, catechol­O­methyltransferase; Camellia sinensis; ConA, Concanavalin A; DILI, drug­induced liver injury; DILIN, Drug­Induced Liver Injury Network; DO, Diversity Outbred; DS, Dietary Supplement; DSAE, JS3 USP Dietary Supplements Admission Evaluations Joint Standard-Setting Subcommittee; Dietary supplements; EC, (­)­epicatechin; ECG, (­)­epicatechin­3­gallate; EFSA, European Food Safety Authority; EGC, (­)­epigallocatechin; EGCG, (­)­epigallocatechin­3­gallate; FDA, United States Food and Drug Administration; GC, (+)­gallocatechin; GCG, (­)­gallocatechin­3­gallate; GT(E), green tea or green tea extract; GT, green tea; GTE, green tea extract; GTEH, EP Green Tea Extract Hepatotoxicity Expert Panel; Green tea; Green tea extract; HDS, herbal dietary supplement; HPMC, Hydroxypropyl methylcellulose; Hepatotoxicity; LD50, lethal dose, median; LFT(s), liver function test(s); LT(s), Liver test(s); Liver injury; MGTT, Minnesota Green Tea Trial; MIDS, multi-ingredient dietary supplement; MRL, maximum residue limit; NAA, N-acetyl aspartate; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NIH, National Institutes of Health; NOAEL, no observed adverse effect level; NTP, National Toxicology Program; OSM, online supplementary material; PAs, Pyrrolizidine Alkaloids; PD-1, Programmed death domain-1; PDGTE, powdered decaffeinated green tea extract; PK/PD, pharmacokinetics and pharmacodynamics; RUCAM, Roussel Uclaf Causality Assessment Method; SIDS, single-ingredient dietary supplement; TGF-beta, Transforming growth factor beta; USP, United States Pharmacopeia; γ-GT, Gamma-glutamyl transferase

Full text: 1 Database: MEDLINE Type of study: Prognostic_studies / Systematic_reviews Language: En Year: 2020 Type: Article

Full text: 1 Database: MEDLINE Type of study: Prognostic_studies / Systematic_reviews Language: En Year: 2020 Type: Article