Pharmacokinetic Allometric Scaling of Oligonucleotides

被引:10
|
作者
Mahmood, Iftekhar [1 ]
机构
[1] US FDA, Off Blood Review & Res OBRR, Ctr Biol Evaluat & Res, Rockville, MD USA
关键词
HUMAN DRUG CLEARANCE; OLIGODEOXYNUCLEOTIDE PHOSPHOROTHIOATE GEM-91; MODIFIED ANTISENSE OLIGONUCLEOTIDE; NECROSIS-FACTOR-ALPHA; PHASE-I TRIAL; INTRAVENOUS-INFUSION; PREDICTION; HUMANS; BCL-2; METABOLISM;
D O I
10.1089/nat.2011.0299
中图分类号
Q5 [生物化学]; Q7 [分子生物学];
学科分类号
071010 ; 081704 ;
摘要
The objective of this study was to evaluate the predictive performance of interspecies scaling of oligonucleotides to predict clearance and volume of distribution at steady state in humans from animal data. The human pharmacokinetic parameters were predicted using 1, 2, or at least 3 animal species. The results of the study indicated that the pharmacokinetic parameters of oligonucleotides can be predicted with reasonable accuracy in humans when at least 3 animal species are employed. On the other hand, allometric scaling based on 1 or 2 species or fixed coefficient or fixed exponent can be erratic and unreliable. Further work should be conducted in this direction.
引用
收藏
页码:315 / 321
页数:7
相关论文
共 50 条
  • [1] Interspecies Pharmacokinetics. 1. Allometric Scaling of Pharmacokinetic Parameters (a Review)
    Polekhina, O. V.
    Obraztsov, N. V.
    Petrunin, V. A.
    Vysotskaya, T. A.
    PHARMACEUTICAL CHEMISTRY JOURNAL, 2014, 48 (07) : 421 - 429
  • [2] The application of allometric scaling principles to predict pharmacokinetic parameters across species
    Huang, Qingbiao
    Riviere, Jim E.
    EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY, 2014, 10 (09) : 1241 - 1253
  • [3] Pharmacokinetic allometric scaling of coagulation factors and tissue-type plasminogen activators
    Mahmood, I.
    HAEMOPHILIA, 2009, 15 (05) : 1109 - 1117
  • [4] Pharmacokinetic Allometric Scaling of Antibodies: Application to the First-In-Human Dose Estimation
    Mahmood, Iftekhar
    JOURNAL OF PHARMACEUTICAL SCIENCES, 2009, 98 (10) : 3850 - 3861
  • [5] Allometric scaling of clearance in dogs
    Martinez, M.
    Mahmood, I.
    Hunter, R. P.
    JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS, 2009, 32 (05) : 411 - 416
  • [6] Designing first-in-human dose of coagulation factors: application of pharmacokinetic allometric scaling
    Mahmood, I.
    HAEMOPHILIA, 2014, 20 (01) : 32 - 38
  • [7] Allometric scaling for therapeutic protocols in wildlife medicine
    Freitas, Gabrielle Coelho
    Carregaro, Adriano Bonfim
    CIENCIA RURAL, 2013, 43 (02): : 297 - 304
  • [8] Allometric scaling in animals and plants
    Dreyer, O
    Puzio, R
    JOURNAL OF MATHEMATICAL BIOLOGY, 2001, 43 (02) : 144 - 156
  • [9] Allometric scaling laws of metabolism
    da Silva, Jafferson Kamphorst Leal
    Garcia, Guilherme J. M.
    Barbosa, Lauro A.
    PHYSICS OF LIFE REVIEWS, 2006, 3 (04) : 229 - 261
  • [10] Dose Prediction and Pharmacokinetic Simulation of XZP-5610, a Small Molecule for NASH Therapy, Using Allometric Scaling and Physiologically Based Pharmacokinetic Models
    Zhang, Lei
    Feng, Feifei
    Wang, Xiaohan
    Liang, Hao
    Yao, Xueting
    Liu, Dongyang
    PHARMACEUTICALS, 2024, 17 (03)