WHO laboratory manual for the examination and processing of human semen

Validation of new methods.

Matrix effects: the Achilles heel of quantitative high-performance liquid chromatography-electrospray-tandem mass spectrometry.

The Third AAPS/FDA Bioanalytical Workshop, entitled “Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays” was held on May 1–3, 2006 in Arlington, VA. The format of this workshop consisted of presentations on bioanalytical topics, followed by discussion sessions where these topics could be debated, with the goal of reaching consensus, or identifying subjects where addition input or clarification was required. The discussion also addressed bioanalytical validation requirements of regulatory agencies, with the purpose of clarifying expectations for regulatory submissions. The proceedings from each day were reviewed and summarized in the evening sessions among the speakers and moderators of the day. The consensus summary was presented back to the workshop on the last day and was further debated. This communication represents the distillate of the workshop proceedings and provides the summary of consensus reached and also contains the validation topics where no consensus was reached.

Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

Purpose.With this publication a subcommittee of the AAPS Ligand Binding Assay Bioanalytical Focus Group (LBABFG) makes recommendations for the development, validation, and implementation of ligand binding assays (LBAs) that are intended to support pharmacokinetic and toxicokinetic assessments of macromolecules.

Recommendations for the Bioanalytical Method Validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules

This report is a synthesis of (1) the earlier conference on Analytical Methods Validation−Bioavailability, Bioequivalence and Pharmacokinetic Studies (Conference held in Arlington, VA, December 3–5, 1990 and the report published in Pharmaceutical Research, 9: 588-592, 1992) and (2) the workshop on “Bioanalytical Methods Validation—A Revisit with a Decade of Progress,” (Workshop held in Arlington, VA, January 12–14, 2000), sponsored by the American Association of Pharmaceutical Scientists and the U. S. Food and Drug Administration. The bioanalytical method validation workshop of January 12–14, 2000 was directed towards small molecules. A separate workshop was held in March 1–3, 2000 to discuss validation principles for macromolecules. The purpose of this report is to represent the progress in analytical methodologies over the last decade and assessment of the major agreements and issues discussed with regard to small molecules at both the conference and the workshop. The report is also intended to provide guiding principles for validation of bioanalytical methods employed in support of bioavailability, bioequivalence, and pharmacokinetic studies in man and in animals.

Bioanalytical method validation--a revisit with a decade of progress.

A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

Controlled release hydrocodone formulations

Controlled release hydrocodone

FIELD: pharmaceutical industry. ^ SUBSTANCE: invention discloses solid oral dozed pharmaceutical form of hydrocodon with controlled release. Pharmaceutical form comprises analgetically effective amount of hydrocodon or pharmaceutically acceptable salt thereof and controlled-release material. Pharmaceutical forms of hydrocodon are suitable to be administered once a day and provides early commencement of therapeutical effect, which lasts at least about 24 h. ^ EFFECT: enhanced analgetic action. ^ 44 cl, 3 tbl, 3 ex

Controlled-release hydrocodon composition

FIELD: medicine, pharmacy. ^ SUBSTANCE: invention describes oral medicinal formulation of sustained-release hydrocodon (variants). The medicinal formulation comprises amount of hydrocodon or its pharmaceutically acceptable salt providing analgetic effect, from 0.5 mg to 1250 mg, and a substance used for the sustained releasing that is sufficient for providing medicinal formulation state allowing its administration in patient two times per 24 h. Medicinal form provides the average ratio C12/Cmax from 0.55 to 0.85 being the indicated medicinal formulation provides the therapeutic effect for at least 12 h. Invention provides enhancing effectiveness and quality of pain control in patients suffering with the moderate pain. ^ EFFECT: valuable pharmaceutical properties of formulation. ^ 42 cl, 3 dwg, 23 tbl, 9 ex

Alfred P. Tonelli

Papers

Bioanalytical method validation--a revisit with a decade of progress.

Controlled release hydrocodone formulations

Controlled release hydrocodone

Controlled-release hydrocodon composition

Hydrocodon preparative sustained-release formulations