Study conduct, good laboratory practice

As vith human pharmaceuticals, all safety studies must be conducted in accordance vdth the principles of Good Laboratory Practice (GLP). Similar to the International Conference on Harmonisation (ICH), the Veterinary International Conference on Harmonisation (VICH) has developed agreed guidelines on the types of test and other considerations that need to be addressed during the development and evaluation of veterinary medicines. A list ofVICH guideline topics is provided in Table 7.1. 

The name, the type and the batch number of the test item should be supplied with the formulation. A GLP (conducted to Good Laboratory Practice) Certificate of Analysis (C of A) detailing the above and also providing confirmation of the amount of active ingredient present in the particular batch of test item to be used in the study should be detailed. This description should include the date of receipt, the amount received. 

All UK facilities conducting regulatory studies must be members of the UK Good Laboratory Practice compliance program and all regulatory studies must be conducted... 

At this stage in planning, the essential study design information listed below should be determined and a written study plan (i.e., protocol) including these key study details prepared. A formal, pre-approved study plan is required for field soil dissipation studies conducted under Good Laboratory Practice (GLP). A written study plan for non-GLP studies is highly recommended since the document serves as valuable guidance for study personnel. 

Analytical chemistry is a critical component of worker safety, re-entry, and other related studies intended to assess the risk to humans during and subsequent to pesticide applications. The analytical aspect takes on added significance when such studies are intended for submission to the U.S. Environmental Protection Agency and/or other regulatory authorities and are thus required to be conducted according to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Good Laboratory Practice (GLP) Standards, or their equivalent. This presentation will address test, control, and reference substance characterization, use-dilution (tank mix) verification, and specimen (exposure matrix sample) analyses from the perspective of GLP Standards requirements. 

Test facilities in the OECD (Organization for Economic Co-operation and Development) member countries that conduct regulatory studies must comply with the OECD Principles of Good Laboratory Practice (GLP), as set out in Council Decision C(97)186/Final. These are referred to as GLP Principles. GLP came into prominence in the late 1970s in response to some malpractice in research and development activities of pharmaceutical companies and contract... 

The Directive contains these other requirements concerning toxicity information and test data (1) Notifications must include descriptions of the studies conducted and methods used (Article 6(1), and Annex VII, Introductory Statements) (2) The tests must be performed according to the methods specified in Annex V (Article 3(1)), and must be "recognized and recommended by the competent international bodies where such recommendations exist" (Annex VII, Introductory Statements) (3) The persons who carry out the tests must comply with the principles of current good laboratory practice (Annex VII, Introductory Statements) and (4) The notifications must include the composition of samples used in testing, and the name of the persons responsible for carrying out the studies (Annex VII, Introductory Statements). 

Immature female Wistar rats (15 days old) were housed individually in wire mesh cages with solid floors. Artificial light was maintained as a 12/12 h light/dark cycle under standard humidity and temperature conditions. Animals were weaned on conventional standardised laboratory diets. Diet and water were available ad libitum. All animals were acclimatised for 24 h before their injection. The study was conducted in accordance with the OECD Good Laboratory Practice Procedures [21]. 

For TM to be accepted into mainstream medical treatment, a likely scenario is the application of scientific methodologies and controls for TM development, evaluation, and production. Many of the tools for high throughput screening (HTS) and assay systems can be used to test the efficacy of TM, similar to the irrational approach of screening natural products. Pharmacology studies have to be conducted in accordance with Good Laboratory Practice (GLP). 

The 1989 OECD council decision Recommendation on Comphance with Good Laboratory Practice requires the establishment of national comphance monitoring program based on laboratory inspections and study audits and recommends the use of the guides for comphance monitoring procedures for good laboratory practice and the guidance for the conduct of laboratory inspections and study audits. 

The Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

All pivotal studies, such as the main teratology study and any range-finding study performed to support the inclusion of women of childbearing potential in clinical trials, must be conducted in compliance with Good Laboratory Practice. 

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