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Evaluation of Orally Administered Highly Variable Drugs and Drug Formulations

• Vinod P. Shah, Avraham Yacobi, +14 authors Roger L Williams
• Pharmaceutical Research
• 1996

The Role of Metabolites in Bioequivalency Assessment. I. Linear Pharmacokinetics without First-Pass Effect

• Mei-Ling Chen, André J. Jackson
• Pharmaceutical Research
• 1991

The estimation of bioequivalency using metabolite data was investigated for immediate release formulations with drugs exhibiting linear pharmacokinetics and no first-pass effect. This was… (More)

Truncated Area Under the Curve as a Measure of Relative Extent of Bioavailability: Evaluation Using Experimental Data and Monte Carlo Simulations

• André J. Jackson, Larry A. Ouderkirk
• Pharmaceutical Research
• 1999

The Role of Metabolites in Bioequivalency Assessment. II. Drugs with Linear Pharmacokinetics and First-Pass Effect

• Mei-Ling Chen, André J. Jackson
• Pharmaceutical Research
• 1995

Simulations were conducted to address the question of whether metabolite data are required for bioequivalence evaluation of immediate release formulations with drugs exhibiting linear… (More)

Pharmacokinetics of morphine and its surrogates. III: Morphine and morphine 3-monoglucuronide pharmacokinetics in the dog as a function of dose.

• Edward R. Garrett, André J. Jackson
• Journal of pharmaceutical sciences
• 1979

The pharmacokinetics of morphine and its derived metabolite, morphine 3-monoglucuronide, were studied in normal and bile-cannulated dogs. High doses (7.2-7.7 mg/kg iv) caused renal and biliary… (More)

Plasma pharmacokinetics of intravenously administered atropine in normal human subjects.

• Richard G. Adams, Pritam S. Verma, André J. Jackson, Richard L. Miller
• Journal of clinical pharmacology
• 1982

The pharmacokinetics of atropine (dl-hyoscyamine) was studied in six normal volunteers following a single 1-mg intravenous dose of atropine. Atropine plasma levels were collected for 24 hours and… (More)

Aspirin increases the human hypothalamic-pituitary-adrenal axis response to naloxone stimulation.

• Gregory I. Hockings, Jeffrey Ernest Grice, Georgina V. Crosbie, Margaret M. Walters, André J. Jackson, Richard V Jackson
• The Journal of clinical endocrinology and…
• 1993

Prostaglandins are believed to influence hypothalamic-pituitary-adrenal (HPA) axis function, but their specific effects on ACTH and cortisol secretion in humans are unclear. Acetylsalicylic acid… (More)

Use of Partial AUC (PAUC) to Evaluate Bioequivalence—A Case Study with Complex Absorption: Methylphenidate

• Jeanne Fourie Zirkelbach, André J. Jackson, Yaning Wang, Donald J. Schuirmann
• Pharmaceutical Research
• 2012

Methylphenidate modified-release products produce early and late peak concentrations critical for treatment of morning and afternoon symptoms of attention deficit hyperactivity disorder (ADHD).… (More)

Individualized, discrete event, simulations provide insight into inter- and intra-subject variability of extended-release, drug products

• Sean H. J. Kim, André J. Jackson, Rim Hur, C. Anthony Hunt
• Theoretical Biology and Medical Modelling
• 2012

Develop and validate particular, concrete, and abstract yet plausible in silico mechanistic explanations for large intra- and interindividual variability observed for eleven bioequivalence study… (More)

Role of metabolites for drugs that undergo nonlinear first-pass effect: impact on bioequivalency assessment using single-dose simulations.

• April C. Braddy, André J. Jackson
• Journal of pharmaceutical sciences
• 2010

We investigated the effects of dose and intrasubject variability (ISV) on bioequivalence (BE) of a parent drug with a single metabolite formed by nonlinear first-pass. A BE simulation was done using… (More)

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