Testing of drugs

It is unlikely that the thorny problem of animal testing will disappear for a long time. As can be seen already, there are so many variables involved in determining whether a drug will be effective or not that it is impossible to anticipate them all. One has also to take into account that the drug will be metabolized to other compounds, all with then-own range of biological properties. 

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An added complexity, but one that may better predict therapeutic activity, is the testing of drugs in assays with different contexts (i.e., basal stimulation). 

Testing of drug products for reconstitution at the time of dispensing (as directed in the labeling) as well as after they are reconstituted. 

We have evaluated the dose-related effects of PCP, ketamine, and selected anticonvulsant drugs on seizure activity in the hippocampal model of kindled seizures. The hippocampal model is particularly well suited for the study of the anticonvulsant effects of drugs because of the slow rate of acquisition of the fully kindled seizure. Electrical stimulation of the dorsal hippocampus initially evokes a stereotyped sequence of behavior, accompanied by a characteristic EEG pattern. Repeated electrical stimulation eventually results in generalized kindled seizures. This allows the testing of drugs on the unkindled hippocampal seizure (afterdischarge) to be compared to effects on the fully kindled seizure in the same rats. 

The synthesis of a monocarbamate (monothiocarbamate) from trihydroxy-abdenone, CDI, and piperidine is described in conjunction with tests of drugs for treatment of glaucoma [205]... 

Recent US FDA guidance on safety testing of drug metabolites [5] highlights the importance of measuring major metabolites in human and toxicological species. This increased scrutiny on the role of metabolites in the evaluation of efficacy and safety will lead to increasing demand for metabolites as analytical standards. 

US Food Drug Adminstration (2008) Guidance for Industry, Safety Testing of Drug Metabolites, http //www.fda. gov/cder/guidance/index.htm (last access October 2008). 

JMHW (1984). Guidelines for Testing of Drugs for Toxicity. Pharmaceutical Affairs Bureau, Notice No. 118. Ministry of Health and Welfare, Japan. 

Sun D, Lawrence XY, Hussain MA, Wall DA, Smith RL, Amidon GL (2004) In vitro testing of drug absorption for drug developability assessment Forming an interface between in vitro preclinical data and clinical outcome. Curr. Opin. Drug Discov. Dev. 7 75-85. 

For autosampler precision, 10 consecutive lO-pL injections of an eth-ylparaben solution (20 J,g/mL) are used (Figure 6). A Waters Symmetry column packed with 5- J,m particles is used. The manufacturer s specification for peak area precision at 0.5% RSD is adopted as the acceptance criterion. This stringent precision criterion is required for precise assay testing of drug substances typically specified at 98-102% purity. The linearity test is performed by single injections of 5, 10, 40, and 80 pL of the... 

Stability testing of drug compound Stability testing of pharmaceutical formulations and packagings... 

TABLE 2 System Suitability Test Parameters Typically Applied in Testing of Drug Substance and Drug Product Materials... 

TABLE 6 ICH Guidelines Affecting the Analytical Testing of Drug Substances and Drug Products Valid as of November 2005... 

This volume contains frank discussion of the ethical compass that guided our work, particularly with respect to informed consent. Some chapters describe, and occasionally take issue with comments appearing in both military and civilian publications, particularly between 1965 and 1982, when public concern about the Army s testing of drugs in human volunteers dramatically escalated. 

C.A. Martin, Evaluating the utility of fiber optic analysis for dissolution testing of drug products, Dissol. TechnoL, 10(4), 37-39 (2003). 

ICH QID Bracketing and matrixing designs for stability testing of drug substances and drug products Step 5 (2002)... 

Best Pharmaceuticals for Children Act reauthorising these provisions, with changes, for another 5 years. The 2002 Act, like the 1997 provisions, relies upon incentives for voluntary industry testing of drugs used for children. 

Clinical trials— Tests of drugs on human subjects. 

M.L. West, D. Fairlie, Targeting HIV-1 protease A test of drug-design methodologies. Trends Pharmacol. Sci. 16 (1995) 67-74. 

Temple, R.J. (1985) Food and Drug Administration s guidelines for clinical testing of drugs in the elderly. Drug Inform 19 483-486. 

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