Clinical evaluation, drugs

This drug also is reported to activate macrophages, to iaduce polyclonal B-ceU activation as well as enhance specific antibody production m vivo, and to iaduce the synthesis of iaterferon and interleukin 1 (52). The iaduction of these important cytokiaes (and others) largely accounts for the profile of biological activity displayed by the pyrimidinones. Bropirimine is currentiy ia clinical evaluation for cancer, arthritis, and immunorestoration ia AIDS patients. 

El 4 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Pharmacogenomics... 

A testosterone microsphere system for treatment of hypogonadol males has been developed and clinically evaluated (61,78). This formulation is based on a glycolide/DL-lactide copolymer and natural testosterone (Fig. 6). Because testosterone is not a very potent compound, about 600 mg of the drug is needed in adult males over a 90-day period. The performance of the testosterone system in baboons is shown in Fig. 7. Similar formulations have also been used in the control of the wild horse population of the western United States. Stallions were injected with a testosterone microsphere formulation designed to inhibit sperm production over a 6-month period (79). 

The clinical evaluation of a new drug is divided into three phases. The first phase of human testing considers what chemical actions a drug has, how it is... 

Biological activity is not the only criterion required for drug development, as anyone who has been involved in this area is aware. Potency, toxicity, bioavailability, metabolic stability, and plasma half-life are only a few of the critical issues that must be addressed. Although satisfactory potency and spectrum activity had been achieved with WIN54954, which has been clinically evaluated, this compound lacked metabolic stability and consequently displayed a short half-life. 

After the approval of the first product, recombinant insulin, in 1982, progress in the development of new recombinant protein pharmaceuticals was slow ([10], Fig. 17.1). The number of biotechnology-derived drugs and vaccines approved by the US Food and Dmg Administration (FDA) has increased significantly only since 1995. More recently, sales of biologies have skyrocketed, e.g. from 900 million in 1999 to an estimated 3.5 billion in 2001 for monoclonal antibodies [11]. The annual global market for biopharmaceuticals is estimated to have increased from 12 billion US to 30 billion US in 2003 [12]. 500 candidate biopharmaceuticals are undergoing clinical evaluation and over one hundred protein-based therapeutics are in the... 

From investigations of the effect of emorfazone on liver drug-metabolizing enzymes, (3) has been classified as a phenobarbitone (phenobarbital)-type inducer of enzymes [65]. For results of clinical evaluations of emorfazone, see [66, 67],... 

The data on the adverse reactions of the fluoroquinolones which have received the most extensive clinical evaluation (ciprofloxacin, ofloxacin, pefloxacin, norfloxacin and enoxacin), involving about 30,000 patients, have been the subject of a review [54a], An important point noted in this review involves the difficulty in detecting an important severe adverse reaction if it is of relatively low frequency, until there has been a very large patient exposure (some examples are provided in which at least 150,000-300,000 exposures would be required to observe the importance of side-effects, resulting in an alert, which have been discovered with specific drugs). However, the majority of side-effects observed thus far with the fluoroquinolones have been minor,... 

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. 

ICH Topic E14-The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. EMEA.(2005) http //emea.eu.int/pdfs/human/ich/ 000204en.pdf. (last accessed 2/25/2007). 

Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 guideline. Journal of Clinical Pharmacology, 46, 498-507. 

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