The dose level of Drug XYZ is 60 mg/m2 (Hint: Use the table found in p.19 for the conversion factors)a. What is the dose in body weight (mg/kg) basis in dogs?b. What is the dose in body weight (mg/kg) basis in rats?c. What is the dose in body weight (mg/kg) basis in monkeys?d. What is the dose in body weight (mg/kg) basis in humans?Reference:Guidance for IndustryEstimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteersthe picture attached to my question is page 19 on my pdf Pharmacologically active dose (PAD): The lowest dose tested in an animal species with theintended pharmacologic activity.Safety factor (SF): A number by which the HED is divided to introduce a margin of safetybetween the HED and the maximum recommended starting dose.W: Body weight in kg15Contains Nonbinding RecommendationsΑPΡENDIX A:Analysis of Allometric Exponent on HED CalculationsAn analysis was conducted to determine the effect of the allometric exponent on the conversionof an animal dose to the HED. One can derive the following equation (see Appendix C) forconverting animal doses to the HED based on body weights and the allometric exponent (b):HED = animal NOAEL x (Wanimal/Whuman)Conventionally, for a mg/m? normalization b would be 0.67, but a number of studies (includingthe original Freireich data) have shown that MTDS scale best across species when b = 0.75. TheInteragency Pharmacokinetics Group has recommended that W.75 be used for interspeciesextrapolation of doses in carcinogenicity studies (EPA 1992). There are no data, however, toindicate the optimal method for converting NOAELS to HEDS. Conversion factors werecalculated over a range of animal and human weights using (Wanimal/Whuman)-33(Wanimal/Whuman)"0.67. The results are shown in Table 2. Using an allometric exponent of 0.75 had a big effect onthe conversion factor for the smaller species mice and rats. Nonetheless, mice are not commonlyused for toxicology studies to support the first-in-human clinical trials. In addition, there isevidence that the area under the plasma concentration versus time curves in rats and humanscorrelates reasonably well when doses are normalized to mg/m (Contrera et al. 1995). Weconclude that the approach of converting NOAEL doses to an HED based on body surface areacorrection factors (i.e., b = 0.67) should be maintained for selecting starting doses for initialstudies in healthy volunteers since: (1) mg/m² normalization is widely used throughout thetoxicology and pharmacokinetic research communities; (2) mg/m² normalization provides a moreconservative conversion; (3) there are no data to suggest a superior method for convertingNOAELS; and (4) CDER has significant experience in establishing safe starting doses based onmg/m, and it is readily calculated.or0.25to assess the effect on starting dose selection of using b = 0.75 instead of bTable 2: Effect of Allometric Exponent on Conversion Factor"Conversion Factors®Ratio of0.75 to 0.67Weight Range(kg)SpeciesStandardb = 0.67b = 0.75MouseRatRabbitMonkeyDogconversion factor = (Wanimal/Whuman)'° human weight range used was 50-80 kg (110-176 lb)' mean conversion factor calculated across entire animal weight range and human weight0.018-0.0330.0810.0750.1411.880.09-0.400.1620.1560.2451.571.301.271.5-30.3240.330.431.5-40.3240.370.476.5-13.00.5410.530.621.17(1-b)range16Contains Nonbinding Recommendations

Animals are used in the vast majority of pharmaceutical research. It is carried out in order to keep…

The dose level of Drug XYZ is 60 mg/m2 (Hint: Use the table found in p.19 for the conversion factors) a. What is the dose in body weight (mg/kg) basis in dogs? b. What is the dose in body weight (mg/kg) basis in rats? c. What is the dose in body weight (mg/kg) basis in monkeys? d. What is the dose in body weight (mg/kg) basis in humans?

The dose level of Drug XYZ is 60 mg/m2 (Hint: Use the table found in p.19 for the conversion factors) a. What is the dose in body weight (mg/kg) basis in dogs? b. What is the dose in body weight (mg/kg) basis in rats? c. What is the dose in body weight (mg/kg) basis in monkeys? d. What is the dose in body weight (mg/kg) basis in humans?

Comprehensive Medical Terminology

4th Edition

ISBN:9781133478850

Author:Jones

Publisher:Jones

Chapter22: Pharmacology

Section: Chapter Questions

Problem B8CRE

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