Toxicology expert reports

Working PK, Dayan AD. Pharmacological-toxicological expert report Caelyx (Stealth liposomal doxorubicin HCL). Hum Exp Tox 1996 15 752. 

Green, J.D. 1994. Pharmaco-toxicological expert report Pulmozyme rhDNase Genentech, Inc. Hum. Exp. Toxicol. 13 Suppl 1 S1—S42. 

J. D. Green. Pbarmaco-toxicological expert report. Pulmozyme3 rtiDNase Genentech, Inc. Hum. Exp. Ibxicol 7J SI-42 (1994). 

Green, J.D. Pharmacological-toxicological (expert report on recombinant human deoxyribonuclease I (rhDNase pulmo-zyme ). Human Experimental Toxicology 1994, 13, S1-S42. 

Green, J.D. Pharmaco-toxicological expert report pulmozy-me rhDNAse genentech, Inc. Human Exptl. Toxicol. 1994, 75 (suppl. 1), S1-S427. 

For most of our purposes, the data on packaging is included only in the chemistry and pharmacy section and in the pharmaceutical expert report, although if a new plastic or polymer material is used, toxicology data may be required along with comment in the toxicology expert report. 

The summary (or abstract) is the most important section of a regulatory toxicology report. Yet, strangely, it is often the section to which the author devotes the least attention. The majority of users of the report will only refer to this section and have no wish to delve into the complexities of the study. It is in the interest of the author to provide the user with the information that he seeks as quickly as possible. Bear in mind that summary text will most likely be copied and pasted into numerous other documents, such as the expert report. 

Finally, the Auschwitz State Museum itself ordered an expert report to be compiled. The Institute for Forensic Research, Toxicology Division, of Cracow, Poland, named after Prof. Dr. Jan Sehn, prepared this report under Prof. Dr. J. Markiewicz on September 24, 1990, which confined itself to the analysis of masonry samples.56 The report concluded that the reason why Leuchter s samples from the homicidal gas chambers were mostly negative with respect to traces of cyanide was because the cyanide compounds had been exposed for more than 40 years to weathering, which these compounds allegedly could not have withstood. Three of these authors from the Jan Sehn Institute later published additional findings,57 which were, however, based on a veri-fiably incorrect analytical method—as was the first series of analy-... 

There is an ongoing discussion as to what degree the data from a single study should be finally interpreted. A comprehensive picture of the toxicological properties is optimal if all data from all studies necessary for submission are available. Therefore, it is recommended to conduct a final evaluation in the expert report only. Otherwise, interpretation of results from single studies needs to be revised. 

The Expert Panel of the American College of Toxicology. Final report on the safety assessment of benzethonium chloride and methylbenzethonium chloride./Aw Coll Toxicol 1985 4 65-106. 

Abridged applications— Applying Article 5133 b of CSP for an application for a product equivalent to a preparation in 3i Pharmacopoeia or National Formulary, the applicant may dispense with the expert report on the pharmacology, toxicology and clinical data, if the following are demonstrated ... 

The European Community, and other countries, requires several expert reports in each dossier, one of which examines the nonclinical toxicology of the new drug. These documents are typically about 20-30 pages long and again summarize all the toxicology data, as well as the clinical implications. 

Modules II-V and an introductory document. The summaries cover manufacturing and quality control, nonclinical information (including toxicology) and a clinical overview (comparable to the expert report in previous forms of European submissions). 

Expert reports on pharmaceutical, pharmacological-toxicological and clinical data. 

In order to be able to estimate the possible risks when working with chemical preservatives, before they are used in practice for the first time the toxicology should be evaluated on the basis of the expert reports that are available for the products. 

One of the few phytochemicals that has been subjected to the rigorous testing procedures required by food safety authorities is P-carotene, a naturally-occurring carotenoid that is also a pre-cursor of vitamin A in humans. It is increasingly used as a food colour since the food product can be claimed to contain all natural ingredients. For this reason, detailed toxicological studies were undertaken that enabled the Joint FAO/WHO Expert Committee for Food Additives (JECFA) to set an ADI of 0-5 mg/kg/bw/day based on a NOAEL of 50 mg/day and the application of an uncertainty factor of 10 (JECFA, 1974). This low factor was used because it was argued that the compound occurred naturally in food, that its use as a food additive would not lead to a substantial increase in the total amount normally consumed, and that there had been no reports of adverse effects in humans. The ADI would correspond to an acceptable intake in humans of up to 350 mg/day. 

The toxicological data will be sent to a WHO expert for evaluation, with a second expert appointed to comment on the report prepared for submission to the Expert Committee. The specification will be written based on information submitted by an FAO expert, and another FAO expert will consider the likely consumption. When the Expert Committee meets, these three groups of people discuss the aspects of the toxicology, specification and likely consumption before an additive is approved and an ADI is allocated. 

Like any document, the toxicology report must be fit-for-purpose. Its content and format must be tailored to meet the requirements of the reader (not just the convenience of the author). The main difficulties arise because the report has to serve scientific, administrative, and regulatory functions, which often have contradictory constraints. Furthermore, the document must comply with Good Laboratory Practice (GLP) regulations, which are inconsistent between regions or even within the same region for different types of test substance (see Note 1). Once the report has been issued (in draft or final form), it will be consulted by many different experts, each with their own agenda ... 

Some 6,720 soldiers took part In this program. To understand the extent to which they might have experienced unanticipated longterm or delayed adverse effects, an extensive search of reports, records, and other data was undertaken. This search and study and evaluation of all available information on the involved chemicals themselves were accomplished by expert panels under the direction of the Committee on Toxicology. 

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