Pharmacokinetics assessments

The amounts of ointments and creams people apply are highly individualized. So are the techniques of application. Some patients vigorously rub semisolid formulations into the skin, while others just spread films until they are more or less uniform over the desired area. While pharmacokinetic assessments of a system s delivery attributes is ordinarily done using normal skin (in vitro) or on healthy volunteers (in vivo), the site of its clinical deployment is usually anything but normal. Rather, it is determined by the skin condition to be treated. Clearly, the manufacturer is without control over how a disease is expressed in a particular patient. For many diseases, disease manifestation can be anywhere on the body. Moreover, from individual to individual it varies in intensity and vastness. Thus, more area may be involved in one case than in another, and the barrier function of the skin may be more or less intact in any instance. This creates a set of imponderables with respect to delivery, efficacy, and safety. 

Gotteries, J., Svenheden, A., Alpsten, M., Bake, B., Larsson, A. et al., Gastrointestinal transit of amoxicillin modified-release tablets and a placebo tablet including pharmacokinetic assessments of amoxicillin, Scand. J. Gastroenterol. 1996, 32, 49-53. 

Pharmacology and toxicology information (includes metabolism and pharmacokinetic assessments done in animals)... 

Green DS, Dockens RC, Salazar DE, et al. Coadministration of nefazodone and benzodiazepines. I pharmacokinetic assessment [Abstract]. Clin Pharmacol Ther 1994 55 141. 

Rao, H.V., and D.R. Brown. 1993. A physiologically based pharmacokinetic assessment of tetrachloroethylene in groundwater for a bathing and showering determination. Risk Anal. 13(l) 37-49. 

Desilva B, Smith W,Weiner R, et at. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. (2003) 20 1885-1900. 

Wilding, I., Hardy, J., Maccari, M., Ravelli, V., and Davis, S., Scintigraphic and pharmacokinetic assessment of a multiparticulate sustained release formulation of diltiazem, International Journal of Pharmaceutics, Vol. 76, No. 1-2, 1991, pp. 133-143. 

After careful pharmacokinetic assessment of the effects of fluconazole withdrawal on 24-hour ambulatory blood pressure and nifedipine plasma concentration, the authors concluded that fluconazole can enhance the blood-pressure lowering effects of nifedipine by increasing its plasma concentrations, most likely by inhibiting CYP3A4. 

Rainsford KD. Relationship of nimesulide safety to its pharmacokinetics assessment of adverse reactions. Rheumatology (Oxford) 1999 38(Suppl 1) 4-10. 

Lanusse, C.E., Gascon, L. Prichard, R.K. (1992) Methimazole-mediated modulation of netobimin biotransformation in sheep a pharmacokinetic assessment. Journal of Veterinary Pharmacology and Therapeutics, 15, 267-274. 

A suitable animal model can be used for in vivo pharmacokinetic assessment of a topically applied elastic liposome formulation. Rats and mice are most common but tend to provide an over-estimate compared to human skin as the skin is more permeable. Piglets provide a closer approximation to human skin permeability and have been used for some evaluations of elastic liposomes (9, 34). Appropriate animal ethics committee approval is required. A generalised protocol is outlined in the following section but there can be considerable variation depending on the complexity of information sought, i.e., if the determination of distribution into tissues is required in addition to absorption into the circulation ... 

Determinations of drug levels in the lung and comparison with plasma levels have been used for the pharmacokinetic assessment of inhalation drugs. In such a scenario, drug is typically delivered to the lung of animals or patients, who have... 

Gastrointestinal transit of amoxicillin modified-release tablets and a placebo tablet including pharmacokinetic assessments of... 

Rippley RK et al. Pharmacokinetic assessment of an oral enalapril suspension for use in children. Biopharmaceutics Drug Disposition, 2000, 21 339-344. 

Analytical methods are developed to meet specific needs. For example, pharmacodynamic and pharmacokinetic assessment of a new drug will require the ability to measure it in... 

Although some clinicians believe that the clinical data are sufficient to support widespread use of once-daily aminoglycoside dosingwithout determination of individualized patient pharmacokinetics, other clinicians believe that the data from investigations on once-daily aminoglycosides are incomplete and that patients still should receive individualized pharmacokinetic assessments and dosage adjustments. 

DeSilva, B., Smith, W., Wiener, R., Kelley, M., Smolec, J., Lee, B., Khan, M., Tacey, R., Hill, H., and Celniker, A. (2003) Recommendations for the bioanalytical method validation of ligand binding assays to support pharmacokinetic assessments of macro molecules. Pharmaceutical Research, 20, 1885 1900. 

Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Biotherapeutics... 

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