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Results: 1-17 |
Results: 17
Limits of 80%-125% for AUC and 70%-143% for C-max - What is the impact on bioequivalence studies?
Authors: Hauck, WW Parekh, A Lesko, LJ Chen, ML Williams, RL
Citation: Ww. Hauck et al., Limits of 80%-125% for AUC and 70%-143% for C-max - What is the impact on bioequivalence studies?, INT J CL PH, 39(8), 2001, pp. 350-355
Variability in the bioavailability of phenytoin capsules in males and females
Authors: Meyer, MC Straughn, AB Mhatre, RM Shah, VP Chen, ML Williams, RL Lesko, LJ
Citation: Mc. Meyer et al., Variability in the bioavailability of phenytoin capsules in males and females, PHARM RES, 18(3), 2001, pp. 394-397
Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies
Authors: Lesko, LJ Atkinson, AJ
Citation: Lj. Lesko et Aj. Atkinson, Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: Criteria, validation, strategies, ANN R PHARM, 41, 2001, pp. 347-366
Individual bioequivalence revisited
Authors: Chen, ML Lesko, LJ
Citation: Ml. Chen et Lj. Lesko, Individual bioequivalence revisited, CLIN PHARMA, 40(10), 2001, pp. 701-706
The effects of St John's wort (Hypericum perforatum) on human cytochrome P450 activity
Authors: Wang, ZQ Gorski, C Hamman, MA Huang, SM Lesko, LJ Hall, SD
Citation: Zq. Wang et al., The effects of St John's wort (Hypericum perforatum) on human cytochrome P450 activity, CLIN PHARM, 70(4), 2001, pp. 317-326
Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans
Authors: Lesko, LJ Rowland, M Peck, CC Blaschke, TF
Citation: Lj. Lesko et al., Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans, PHARM RES, 17(11), 2000, pp. 1335-1344
Clinical consequences of 'failed' bioequivalence studies
Authors: Lesko, LJ Bashaw, D Conner, DP Honig, PK
Citation: Lj. Lesko et al., Clinical consequences of 'failed' bioequivalence studies, EUR J DRUG, 25(1), 2000, pp. 69-69
Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans
Authors: Lesko, LJ Rowland, M Peck, CC Blaschke, TF
Citation: Lj. Lesko et al., Optimizing the science of drug development: Opportunities for better candidate selection and accelerated evaluation in humans, J CLIN PHAR, 40(8), 2000, pp. 803-814
Pharmacokinetic/pharmacodynamic modeling in drug research and development
Authors: Derendorf, H Lesko, LJ Chaikin, P Colburn, WA Lee, P Miller, R Powell, R Rhodes, G Stanski, D Venitz, J
Citation: H. Derendorf et al., Pharmacokinetic/pharmacodynamic modeling in drug research and development, J CLIN PHAR, 40(12), 2000, pp. 1399-1418
Clinical pharmacology studies in patients with renal impairment: Past experience and regulatory perspectives
Authors: Ibrahim, S Honig, P Huang, SM Gillespie, W Lesko, LJ Williams, RL
Citation: S. Ibrahim et al., Clinical pharmacology studies in patients with renal impairment: Past experience and regulatory perspectives, J CLIN PHAR, 40(1), 2000, pp. 31-38
Effect of troglitazone on cytochrome P450 enzymes in primary cultures of human and rat hepatocytes
Authors: Sahi, J Hamilton, G Sinz, M Barros, S Huang, SM Lesko, LJ LeCluyse, EL
Citation: J. Sahi et al., Effect of troglitazone on cytochrome P450 enzymes in primary cultures of human and rat hepatocytes, XENOBIOTICA, 30(3), 2000, pp. 273-284
Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics
Authors: Chen, ML Lee, SC Ng, MJ Schuirmann, DJ Lesko, LJ Williams, RL
Citation: Ml. Chen et al., Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics, CLIN PHARM, 68(5), 2000, pp. 510-521
In vivo drug-drug interaction studies - A survey of all new molecular entities approved from 1987 to 1997
Authors: Marroum, PJ Uppoor, RS Parmelee, T Ajayi, F Burnett, A Yuan, R Svadjian, R Lesko, LJ Balian, JD
Citation: Pj. Marroum et al., In vivo drug-drug interaction studies - A survey of all new molecular entities approved from 1987 to 1997, CLIN PHARM, 68(3), 2000, pp. 280-285
FDA evaluations using in vitro metabolism to predict and interpret in vivometabolic drug-drug interactions: Impact on labeling
Authors: Davit, B Reynolds, K Yuan, R Ajayi, F Conner, D Fadiran, E Gillespie, B Sahajwalla, C Huang, SM Lesko, LJ
Citation: B. Davit et al., FDA evaluations using in vitro metabolism to predict and interpret in vivometabolic drug-drug interactions: Impact on labeling, J CLIN PHAR, 39(9), 1999, pp. 899-910
Assessment of the quality and quantity of drug-drug interaction studies inrecent NDA submissions: Study design and data analysis issues
Authors: Huang, SM Lesko, LJ Williams, RL
Citation: Sm. Huang et al., Assessment of the quality and quantity of drug-drug interaction studies inrecent NDA submissions: Study design and data analysis issues, J CLIN PHAR, 39(10), 1999, pp. 1006-1014
Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling
Authors: Singh, GJP Adams, WP Lesko, LJ Shah, VP Molzon, JA Williams, RL Pershing, LK
Citation: Gjp. Singh et al., Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling, CLIN PHARM, 66(4), 1999, pp. 346-357
In vitro metabolic interaction studies: Experience of the Food and Drug Administration
Authors: Yuan, R Parmelee, T Balian, JD Uppoor, RS Ajayi, F Burnett, A Lesko, LJ Marroum, P
Citation: R. Yuan et al., In vitro metabolic interaction studies: Experience of the Food and Drug Administration, CLIN PHARM, 66(1), 1999, pp. 9-15
Risultati: 1-17 |