WHO Expert Committee on Specifications for Pharmaceutical Preparations.

Evaluation of certain food additives. Eighteenth Report of the Joint FAO/WHO Expert Committee on Food Additives.

This report presents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives, with a view to recommending Acceptable Daily Intakes (ADIs) for humans, and to prepare specifications for the identity and purity of food additives. The first part of the report contains a general discussion of the principles governing the toxicological evaluation ...

18th Expert Committee on the Selection and Use of Essential Medicines Review of medicines for the treatment of common tumours in children

Page 1 of 42 Quality by Design Specifications for Solid Oral Dosage Forms: Multivariate Product and Process Monitoring for Managing Drug Quality Attributes by the Specification Design and Lifecycle Management Working Group of the PQRI Manufacturing Technical Committee Preamble

The purpose of this paper is to stimulate discussion around the thought processes and activities that occur from creation through development and commercialization of a molecule that ultimately becomes a drug product that benefits patients. This includes exploring the scientific evidence and pharmacological underpinnings that link clinical concepts to drug product design, manufacturing controls...

Evaluating the quality and use of economic data in decisions about essential medicines.

OBJECTIVE To evaluate the quality of economic data provided in applications to the World Health Organization (WHO) Model List of Essential Medicines and to evaluate the role of these data in decision-making by the expert committee that considers the applications. METHODS We analysed applications submitted to the WHO Expert Committee on the Selection and Use of Essential Medicines between 2002...

579. Erythrosine (WHO Food Additives Series 19)

Erythrosine (FD&C Red No. 3) is widely used as a coloring agent for foods, beverages, pharmaceutical preparations, and cosmetics. It has been evaluated for acceptable daily intake by the Joint FAO/WHO Expert Committee on Food Additives (see Annex 1, Ref. Nos. 8, 19 & 35) in 1964, 1969 and 1974. At the 18th Meeting (1974) of the Committee, an ADI of 0 2.5 mg/kg body weight was allocated. Toxicol...