Further Studies on the Relation Between in Vitro Disintegration Time of Tablets and the Urinary Excretion Rates of Riboflavin**Food and Drug Laboratories, Department of National Health and Welfare, Ottawa, Canada

Morrison, A. B.; Chapman, D. G.; Campbell, J. A.

doi:10.1002/jps.3030481108

Cited by 15 publications

(2 citation statements)

References 6 publications

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“…His presentation started by reviewing the historical evolution of the statistical concepts adopted in BE testing. It was highlighted the fact that the first intimations of BE problems originated from multisource drug products and also inspired by vitamins, aspirin, and tolbutamide (1)(2)(3)(4)(5)(6)(7). The measures of BE were initially defined regarding rate and extent of absorption.…”

Section: Within-subject Variability: Design Determination and Demonstrmentioning

confidence: 99%

“…Various sporadic in vivo observations in the 1950s and 1960s raised the first intimations of bioequivalence (BE) with multi-source drug products (1)(2)(3)(4)(5)(6)(7). It was realized that product efficacy depends on the proportion of the drug which is ultimately absorbed (extent of absorption) from its formulation and how rapidly the drug absorption is being held (rate of absorption).…”

Section: Introductionmentioning

confidence: 98%

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Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability

Karalis

Macheras

Peer³

et al. 2008

Pharm Res

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This is a summary report of the EUFEPS & COST B25 conference on Bioavailability and Bioequivalence which focused on physiological factors and variability. This conference was held at The Royal Olympic Hotel in the centre of Athens (Greece) during the 1-2 of October in 2007. The issues discussed in the conference involved physiological factors affecting drug absorption, the role of pre-systemic effects on bioavailability (BA), the impact of variability in bioequivalence (BE) studies, and a final closing panel session on unresolved issues in BA/BE regulations. Several important aspects of drug absorption were highlighted. It was presented how the complexity of gastrointestinal (GI) physiology and the site dependent absorption can impact on drug BA. Similarly, the effects of food and formulation were also studied. The second session focused on integrating the complexities of GI into modeling the inter-individual variability of absorption and the prediction of first-pass metabolism from in-vitro data. The necessity to measure metabolites, the value of Biopharmaceutical Classification System (BCS), and the more recently proposed Biopharmaceutical Drug Disposition Classification System (BDDCS) were assessed as well. This session closed with presentations of pharmacokinetic software delegates. In the second day of the conference, the problem of high intra-subject variability in BE studies was analyzed. Study design considerations, the use of multiple-dose studies and the role of statistics in BE were also highlighted. Finally, the current thinking of regulatory authorities (EMEA and US-FDA) was presented. The conference closed with a last session on unresolved issues in the regulatory level.

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Section: Within-subject Variability: Design Determination and Demonstrmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 98%

Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability

Karalis

Macheras

Peer³

et al. 2008

Pharm Res

View full text Add to dashboard Cite

show abstract

Pharmacopeial standards and specifications for bulk drugs and solid oral dosage forms. Similarities and differences

French¹,

Matsui²,

Cook³

et al. 1967

Journal of Pharmaceutical Sciences

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Polarography of Gibberellic Acid**Analytical Research Department, Eli Lilly and Co., Indianapolis 6, Ind.

Head

1959

Journal of the American Pharmaceutical Association (Scientific

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Further Studies on the Relation Between in Vitro Disintegration Time of Tablets and the Urinary Excretion Rates of Riboflavin**Food and Drug Laboratories, Department of National Health and Welfare, Ottawa, Canada

Cited by 15 publications

References 6 publications

Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability

Bioavailability and Bioequivalence: Focus on Physiological Factors and Variability

Pharmacopeial standards and specifications for bulk drugs and solid oral dosage forms. Similarities and differences

Polarography of Gibberellic Acid**Analytical Research Department, Eli Lilly and Co., Indianapolis 6, Ind.

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