By Chi-Jen Lee, Lucia H. Lee, Cheng-Hsiung Lu
Since the preliminary booklet of improvement and review medicines from Laboratory via Licensure to marketplace in 1993, many alterations have happened in biomedicine, biotechnology, pharmaceutical technological know-how and expertise, and drug evaluate structures. up to date and improved, this moment variation examines the entire contemporary advances in medical and regulatory techniques in addition to adjustments within the method during which medicines are came across, constructed, and evaluated. Discussions contain scorching themes reminiscent of genome constitution, rational drug layout, sturdy production practices, bioavailability and bioequivalence, and part IV post-marketing tracking, and the ultimate bankruptcy explores destiny challenges.
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Extra info for Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition
H. Experimental procedure: 1. All animals should be observed daily for general changes. Body weights should be measured at least once a week during the first 3 months of administration and at least once every 4 weeks thereafter. 2. Dead animals during the experimental period should be necropsied immediately. Macroscopic and histopathological examinations of organs and tissues should be conducted. 3. Animals that appear to be moribund during the experimental period should be killed and necropsied immediately.
Administration route: intraperitoneal or the proposed clinical route should be used. D. Dose levels: at least three dose groups should be used. The highest dose should cause some toxic symptoms, such as suppression of body weight. E. Control groups: a solvent group should serve as a negative control. A drug known to induce micronuclei should be used as a positive control. © 2003 CRC Press LLC F. Frequency of administration: single or multiple doses may be administered. G. Experimental procedure: 1.
Recovery test The recovery from toxic changes or the appearance of delayed toxicity should be examined in a recovery group in a 1-month or a 3-month study. , Development and Evaluation of Drugs from Laboratory through Licensure to Market, CRC Press, Boca Raton, 1993. With permission. © 2003 CRC Press LLC II. Experimental methods A. Study of administration of the test drug before and during early stage of gestation 1. Animals: at least one species of rodent of both sexes should be used. Species should be selected from among those used in the study during organogenesis (study II).