Evaluation of drugs

TABLE 5.24 Toxicity Studies for Safety Evaluation of Drugs, Pesticides, Food Additives, and Other Chemicais Utilizing Experimental Animals and Other Systems Required by Health Authorities... 

Shitara Y, Sato H, Sugiyama Y (2005) Evaluation of drug-drug interactions in the hepatobiliary and renal transport of drugs. Annu Rev Pharmacol Toxicol 45 689-723... 

Quantified evaluation of drugs that could have been identified in herbal texts. It would be a valuable assessment to quantify the number of pharmaceuticals that have been described with the correct purported uses in an herbal text. A project of this nature would incorporate selecting a historic... 

Parke DV, loannides C, Lewis DFV. The safety evaluation of drugs and chemicals by the use of computer-optimised molecular parametric analysis of chemical toxicity (COMPACT). ATLA 1990 18 91-102. 

Bailey, D.N., Evaluation of drug interferences in the ultraviolet spectrophotometric analysis of plasma theophylline, J. Anal. Toxicol., 2,94,1978. 

Shapiro, D and Oakley, M., Methodological issues in the evaluation of drug behavioral interactions in the treatment of hypertension. Psychosomatic Medicine 51(3), 269-276, 1989. 

Johannesson, M. (1995), Economic evaluation of drugs and its potential uses in policy making , PharmacoEconomics, 8, 190-98. 

Initially, anxious patients should be monitored once to twice weekly for reduction in anxiety symptoms, improvement in functioning, and side effects. The Visual Analog Scale may assist in the evaluation of drug response. 

As the first published requirement for immunotoxicology evaluation of drugs, CPMPZSWP/1042/99 predictably was met with a combination of resistance and confusion. Much of this was allayed in a Drug Information Associated-sponsored workshop held in Noordwijk, The Netherlands in November of 2001. At this meeting, the intent of the guideline was clarified a summary of this workshop, as well as an update, has been published [44, 45],... 

Most studies on spinal reflexes have utilized spinally transected animals. This preparation allows for the evaluation of drug actions on spinal postsynaptic 5-HT receptors without the potential confounding influences of tonic descending 5-HT activity or the influence of supraspinal 5-HT neuronal or receptor activity. 

Goldenthal, E. (1968). Current view on safety evaluation of drugs. FDA Papers, May 1968 13-18. 

Elsberry, D. (1986). Screening approaches for acute and subacute toxicity studies. In Safety Evaluation of Drugs and Chemicals (Lloyd, W., Ed.). Hemisphere Publishing, Washington, D.C., pp. 145-151. 

Malmfors, T. and Teiling, A. (1983). LD50—its value for the pharmaceutical industry in safety evaluation of drugs. Acta Pharmacol. Toxicol. 52 (Suppl. 2) 229-246. 

D Aguanno, W. (1973). Guidelines of reproduction studies for safety evaluation of drugs for human use. In FDA Introduction to Total Drug Quality, DHEW Publ. (FDA) 74-3006, DHEW/PHS/FDA. 

Food and Drug Administration (1966). Guidelines for Reproduction Studies for Safely Evaluation of Drugs for Human Use. Drug Review Branch, Division of Toxicological Evaluation, Bureau of Science, Food and Drug Administration, Washington, D.C. 

Food and Drug Administration (1993). Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs. Federal Register, Thursday, July 22, 1993. Vol. 58, No. 139, pp. 39405-39416. 

R. Bodmeier and H. Chen, Preparation and evaluation of drug containing polymeric nanosuspensions, in 1989 Proc. 5th Int. Conf. Pharm. Tech., pp. B265-268. 

Several specialized reviews on detection of QT liability in the clinical development phase have already been published and the reader is referred to these publications [63]. Guidelines of the International Society for Holter and Noninvasive Electrocardiology (IS H N E) for electrocardiographic evaluation of drug-related QT prolongation are also available [161]. The main issues related to measurement of the QT interval in clinical studies are summarized in Table 3.4. An important aspect is the calculation of sample size usually 40-60 subjects per treatment arm are required, implying high cost [162-164]. 

Malik, M. and Camm, A.J. (2001) Evaluation of drug-induced QT interval prolongation implications for drug approval and labelling. Drug Safety, 24, 323-351. 

Moss, A.J., Zareba, W., Benhorin, J., Couderc, J.P., Kennedy, H., Locati-Heilbron, E. and Maison-Blanche, P. (2001) ISHNE Guidelines for Electrocardiographic Evaluation of Drug-related QT Prolongation and Other Alterations in Ventricular Repolarization Task Force Summary. A Report of the Task Force of the International Society for Holter and Noninvasive Electrocardiology (ISHNE), Committee on Ventricular Repolarization. Annals of Noninvasive Electrocardiology, 6, 333-341. 

As bioanalysis plays a key role during drug discovery and toxico-kinetic/pharmacokinetic evaluation of drug candidates, several improvements have been made in minimizing the time spent in performing bioanalysis and for the evaluation of drug efficacy. 

Osth K, Paulsson M, Bjork E, Edsman K (2002) Evaluation of drug release from gels on pig nasal mucosa in a horizontal Ussing chamber. J Control Rel 83 377-388. 

The DustGun aerosol generator, which has been reported for the delivery of aerosol particles to the IPL for toxicological evaluations [36], is another delivery technique which could be utilised for the evaluation of drug disposition after the delivery of pharmaceutical powder aerosols to the IPL. 

There are several cell monolayer models that are frequently used for the evaluation of drug permeability and absorption potential (Table 18.1). For a more detailed discussion, please refer to Chap. 8. Caco-2 cells (adenocarcinoma cells derived from colon) are the most extensively characterized and frequently used of the available cell lines [5-9], A unique feature of Caco-2 cells is that they undergo spontaneous enterocyte differentiation in cell culture. Unlike intestinal enterocytes, Caco-2 cells are immortalized and replicate rapidly into confluent monolayers. When the cells reach confluency during culture on a semi-porous membrane, they start to polarize and form tight junctions, creating an ideal system for permeability and transport studies. During the past decade, use of... 

Nelson, E. and Schaldemose, I., Urinary excretion for evaluation of drug absorption I, /. Am. 

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