Compound validation

Takacs-Novak, K., Box, K. J., Avdeef, A. Potentiometric pKa determination of water-insoluble compounds. Validation smdy in methanol/water mixmres. Int. J. Pharm. 1997, 151, 235-248. 

In general, only valid studies were used to derive predicted no effect concentrations (PNECs). Because in some cases only a few valid data were available, studies valid with restrictions have been used based on expert judgement. Invalid or non-assignable studies have not been used. In instances of volatile compounds, valid studies were generally those using closed, flow-through systems, preferably with analytical measurements. 

Kistler A (1987) Limb bud cell cultures for estimating the teratogenic potential of compounds. Validation of the test system with retinoids. Arch Toxicol 60(6) 403 14... 

Many commercial suppliers (Table 10.3) have established protocols and procedures that address many of these issues. Primary human and animal cells of a variety of types are often available, sometimes as ready-to-use frozen stock aliquots or already added to 96-or 384-well plates. Specific culturing medium and detailed protocols for the correct maintenance of the cell line in culture are usually provided as well. This should facilitate the use of primary cells for primary HTS and compound validation. 

The biodrug concept involves the use of orally administered recombinant microorganisms as a new drug delivery route to prevent or treat various diseases. The potential medical applications are numerous and can be classified in terms of bioconversion or production of active compounds. Validation studies have yet been conducted in animals (and even sometimes in human being), as described below and summarized in Table 1. 

A description of sanitizing methods and sanitizing compound validation ... 

Source Schneider E, Bolo NR, Frederick B et ai, Magnetic resonance spectroscopy for measuring the biodistribution and in situ in vivo pharmacokinetics of fluorinated compounds validation using an investigation of liver and heart disposition of tecastemizole, J. Clin. Pharm. Ther. (2006) 31, 261-273. Copyright (2006) John Wiley Sons. Reprinted with permission.)... 

Volgyi, G., Ruiz, R., Comer, J., Bosch, E. and Takacs-Novak, K. (2007) Potentiometric and spectrophotometric pfCa determination of water-insoluble compounds validation study in a new cosolvent system. Analytica Chimica Acta, 583, 418 128. 

Suleiman MS, Najib NM. Isolation and physicochemical pKa determination of water-insoluble compounds validation study in methanol/water mixtures. Int J Pharm 1989 151 235-248. 

Takacs-Novak K, Box IQ, Avdeef A, Potentiometric pK determination of water-insoluble compounds Validation study in medianol/water mixtures, Int.. Pharm., 151, 235-248 (1997). NB By extrapolation from 34r-50 %w/w aqueous MeOH. See Acetaminophen for full details. 

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