Top Abstract Purchase Related
Home
>
Node
>
Subnode

Sample size considerations for assessing individual bioequivalence based on the method of tolerance intervals

Esinhart, J.D.; Chinchilli, V.M.

International Journal of Clinical Pharmacology and Therapeutics 32(1): 26-32

1994

ISSN/ISBN: 0946-1965
PMID: 8199749
Document Number: 424127
This is the consideration of sample sizes for assessing individual bioequivalence based on the use of tolerance intervals. The sample size procedures discussed include a direct distribution-free method, indirect parametric method and a direct parametric method. Design considerations are discussed based on the results of the direct parametric method. Tables are provided for easy access of results.

Document emailed within 1 workday
Secure & encrypted payments

Diletti, E.; Hauschke, D.; Steinijans, V.W. 1992: Sample size determination for bioequivalence assessment by means of confidence intervals International Journal of Clinical Pharmacology Therapy and Toxicology 30(Suppl 1): S51-S58
Diletti, E.; Hauschke, D.; Steinijans, V.W. 1991: Sample size determination for bioequivalence assessment by means of confidence intervals International Journal of Clinical Pharmacology Therapy and Toxicology 29(1): 1-8
Rabin, R.L.; Slater, J.E.; Lachenbruch, P.; Pastor, R.W. 2003: Sample size considerations for establishing clinical bioequivalence of allergen formulations Arbeiten aus dem Paul-Ehrlich-Institut Zu Frankfurt A.M 94: 24-33
Hauck, W.W.; Chen, M.L.; Hyslop, T.; Patnaik, R.; Schuirmann, D.; Williams, R. 1996: Mean difference vs. variability reduction: tradeoffs in aggregate measures for individual bioequivalence. FDA Individual Bioequivalence Working Group International Journal of Clinical Pharmacology and Therapeutics 34(12): 535-541
Yuen, K.H.; Wong, J.W.; Yap, S.P.; Billa, N. 2001: Estimated coefficient of variation values for sample size planning in bioequivalence studies International Journal of Clinical Pharmacology and Therapeutics 39(1): 37-40
Indrayan, A.; Gupta, P. 2000: Sampling techniques, confidence intervals, and sample size National Medical Journal of India 13(1): 29-36
Luna del Castillo, J.; Martín Andrés, A. 1990: "and now, how many subjects do i take?" Some basic ideas on sample size (II): sample size in a problem of contrasting hypotheses with 2 samples Atencion Primaria 7(2): 152-155
Wang, R.; Goyal, R.; Lei, Q.; Essex, M.; De Gruttola, V. 2014: Sample size considerations in the design of cluster randomized trials of combination HIV prevention Clinical Trials 11(3): 309-318
Kovalevskiĭ, I.V.; Korenberg, E.I.; Nikitochkin, I.G. 1991: The optimization of a method for assessing the contagiosity and the degree of individual infectiousness of ticks with Borrelia Meditsinskaia Parazitologiia i Parazitarnye Bolezni 3: 18-21
Pai, R.G.; Shah, P.M. 1993: A new Doppler method for assessing left ventricular diastolic stiffness based on principles of flow wave propagation: mathematical basis and review of the method Journal of Heart Valve Disease 2(2): 167-173
William, T.B.; Robert, S. Justin, S.B. 2012: The effects of small sample size and sample bias on threshold selection and accuracy assessment of species distribution models Ecography 35(3): 250-258
Channon, A.A.R. 2011: Can mothers judge the size of their newborn? Assessing the determinants of a mother's perception of a baby's size at birth Journal of Biosocial Science 43(5): 555-573
Tajima, Y. 2000: Cryo-press, a Type of Sample Preparation Method Based on Freeze-Fracture Clinical Laboratory 46(7-8): 365-361
Endrenyi, L.; Hao, Y. 1998: Asymmetry of the mean-variability tradeoff raises questions about the model in investigations of individual bioequivalence International Journal of Clinical Pharmacology and Therapeutics 36(8): 450-457
Rostami-Hodjegan, A.; Jackson, P.R.; Tucker, G.T. 1994: Sensitivity of indirect metrics for assessing "rate" in bioequivalence studies--moving the "goalposts" or changing the "game" Journal of Pharmaceutical Sciences 83(11): 1554-1557
Welch, V.; Singh, G.; Strand, V.; Fries, J.; Boers, M.; Ramey, D.; Day, R.O.; Brooks, P.; Tugwell, P.; Clinch, J.; Kristjansson, B. 2001: Patient based method of assessing adverse events in clinical trials in rheumatology: the revised Stanford Toxicity Index Journal of Rheumatology 28(5): 1188-1191
Schiele, F.; Galteau, M.M.; Siest, G. 1977: Human plasma lactic dehydrogenase activity: individual variations and reference intervals Annales de Biologie Clinique 35(5): 379-386
Hegrenaes, L. 1983: Left ventricular systolic time intervals. A comparison between the conventional carotid pulse curve method and the doppler ultrasound method European Heart Journal 4(5): 313-319
Curtis, C.R.; Salman, M.D.; Shott, S. 1990: Power and sample size Journal of the American Veterinary Medical Association 197(7): 838-840
Ting, T.Y.; Jiang, W.; Lionberger, R.; Wong, J.; Jones, J.W.; Kane, M.A.; Krumholz, A.; Temple, R.; Polli, J.E. 2015: Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: a field test of the FDA bioequivalence standard Epilepsia 56(9): 1415-1424