Clinical trial NCT02294448 - References

Individuality — PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial

Citation(s)

•   Aker PD, Gross AR, Goldsmith CH, Peloso P
  Conservative management of mechanical neck pain: systematic overview and meta-analysis. BMJ. 1996 Nov 23;313(7068):1291-6.
•   Bovim G, Schrader H, Sand T
  Neck pain in the general population. Spine (Phila Pa 1976). 1994 Jun 15;19(12):1307-9.
•   Choo V
  WHO reassesses appropriate body-mass index for Asian populations. Lancet. 2002 Jul 20;360(9328):235.
•   Cui X, Trinh K, Wang YJ
  Chinese herbal medicine for chronic neck pain due to cervical degenerative disc disease. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD006556. doi: 10.1002/14651858.CD006556.pub2. Review.
•   EMEA
  Strategies to identify and mitigate risks for first-in-human clinical trialswith investigational medicinal products; 2009, http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2009/09/WC500002988.pdf.
•   FDA/CDER
  Guidance for industry estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers; 2005, http://www.fda.gov/downloads/drugs/guidance-complianceregulatoryinformation/guidances/ucm078932.pdf.
•   Feng Y, Pollock BG, Coley K, Marder S, Miller D, Kirshner M, Aravagiri M, Schneider L, Bies RR
  Population pharmacokinetic analysis for risperidone using highly sparse sampling measurements from the CATIE study. Br J Clin Pharmacol. 2008 Nov;66(5):629-39. doi: 10.1111/j.1365-2125.2008.03276.x. Epub 2008 Jul 31.
•   Ge JR, Wang HM, Meng CX, Tong PJ
  Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: a randomized controlled trial for Phase III. Chinese Journal of New Drugs and Clinical. 2014(7):56-58.
•   Hsu H-Y: 1986 Oriental MateriaMedica
  Long Beach, CA: Oriental Healing Arts Institute; 1986.
•   Johnson CL, Fulwood R, Abraham S, Bryner JD
  Basic data on anthropometric measurements and angular measurements of the hip and knee joints for selected age groups 1-74 years of age. Vital Health Stat 11. 1981 Apr;(219):1-68.
•   Liu M, Zhang N, Wang YJ, Zhang YQ, Zhou CJ
  Technology research of Qishe Pill, a new medicine for cervical spondylosis. Lishizhen Med Mater Med Res. 2010(21):176-179.
•   Liu Mei, Zhang N, Wang YJ, Shi Q
  Purification process research of major compound in Qishe Pill as Astragalus. Acta Chinese Medicine and Pharmacology. 2006(34):14-16.
•   Mäkelä M, Heliövaara M, Sievers K, Impivaara O, Knekt P, Aromaa A
  Prevalence, determinants, and consequences of chronic neck pain in Finland. Am J Epidemiol. 1991 Dec 1;134(11):1356-67.
•   Sheiner LB, Beal SL
  Evaluation of methods for estimating population pharmacokinetic parameters. II. Biexponential model and experimental pharmacokinetic data. J Pharmacokinet Biopharm. 1981 Oct;9(5):635-51.
•   Sheiner LB, Beal SL
  Evaluation of methods for estimating population pharmacokinetic parameters. III. Monoexponential model: routine clinical pharmacokinetic data. J Pharmacokinet Biopharm. 1983 Jun;11(3):303-19.
•   Sheiner LB, Beal SL
  Evaluation of methods for estimating population pharmacokinetics parameters. I. Michaelis-Menten model: routine clinical pharmacokinetic data. J Pharmacokinet Biopharm. 1980 Dec;8(6):553-71.
•   van der Donk J, Schouten JS, Passchier J, van Romunde LK, Valkenburg HA
  The associations of neck pain with radiological abnormalities of the cervical spine and personality traits in a general population. J Rheumatol. 1991 Dec;18(12):1884-9.
•   Wang Q
  Classification of the nine basic TCM constitutional type and based expression and diagnosis. Journal of Beijing University of Traditional Chinese medicine. 2005.1-8
•   Zhang WJ, Hufnagl P, Binder BR, Wojta J
  Antiinflammatory activity of astragaloside IV is mediated by inhibition of NF-kappaB activation and adhesion molecule expression. Thromb Haemost. 2003 Nov;90(5):904-14.
•   Zhang YQ, Liu XH, Zhang N, Liu M
  Quality standard research of Qishe Pill. Lishizhen Med Mater Med Res. 2008(19): 977-979.
•   Zhu YB, Wang Q, Xue HS, Origasa H
  Preliminary assessment on performance of constitution in Chinese medicine questionnaire. ZhongGuo Lin Chuang Kang Fu 2006; 10 (3): 15-17.

Population Pharmacokinetic Modeling of Qishe Pill in Three Major TCM-defined Constitutional Types of Healthy Chinese Subjects: Study Protocol for a Phase I Clinical Trial

Details for clinical trial NCT02294448