Healthy — Open-Label Pharmacokinetic of Oseltamivir in Healthy Obese Thai Adult Subjects
Citation(s)
Abernethy DR, Greenblatt DJ Drug disposition in obese humans. An update. Clin Pharmacokinet. 1986 May-Jun;11(3):199-213. Review.
Beckel MH Factor affecting the storage of drug and other xenobiotics in adipose tissue. Adv Drug Res 1994; 25: 55-86.
Benedek IH, Blouin RA, McNamara PJ Serum protein binding and the role of increased alpha 1-acid glycoprotein in moderately obese male subjects. Br J Clin Pharmacol. 1984 Dec;18(6):941-6.
Caraco Y, Zylber-Katz E, Berry EM, Levy M Antipyrine disposition in obesity: evidence for negligible effect of obesity on hepatic oxidative metabolism. Eur J Clin Pharmacol. 1995;47(6):525-30.
Massarella JW, He GZ, Dorr A, Nieforth K, Ward P, Brown A The pharmacokinetics and tolerability of the oral neuraminidase inhibitor oseltamivir (Ro 64-0796/GS4104) in healthy adult and elderly volunteers. J Clin Pharmacol. 2000 Aug;40(8):836-43.
Ritschel WA, Kaul S Prediction of apparent volume of distribution in obesity. Methods Find Exp Clin Pharmacol. 1986 Apr;8(4):239-47.
Ward P, Small I, Smith J, Suter P, Dutkowski R Oseltamivir (Tamiflu) and its potential for use in the event of an influenza pandemic. J Antimicrob Chemother. 2005 Feb;55 Suppl 1:i5-i21. Review.
Yen HL, Ilyushina NA, Salomon R, Hoffmann E, Webster RG, Govorkova EA Neuraminidase inhibitor-resistant recombinant A/Vietnam/1203/04 (H5N1) influenza viruses retain their replication efficiency and pathogenicity in vitro and in vivo. J Virol. 2007 Nov;81(22):12418-26. Epub 2007 Sep 12.
Yen HL, Monto AS, Webster RG, Govorkova EA Virulence may determine the necessary duration and dosage of oseltamivir treatment for highly pathogenic A/Vietnam/1203/04 influenza virus in mice. J Infect Dis. 2005 Aug 15;192(4):665-72. Epub 2005 Jul 15.
Phase I, Open-Label Study to Evaluate Potential Pharmacokinetic of Orally Administered Oseltamivir in Healthy Obese Thai Adult Subjects
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
