By Shein-Chung Chow
Emphasizing the function of excellent statistical practices (GSP) in drug learn and formula, this publication outlines very important facts purposes for every level of pharmaceutical improvement to make sure the legitimate layout, research, and evaluation of drug items lower than research and identify the security and efficacy of pharmaceutical compounds. assurance contain statistical suggestions for assay validation and overview of drug functionality features, checking out population/individual bioequivalence and in vitro bioequivalence in line with the newest FDA directions, simple concerns for the layout and research of healing equivalence and noninferiority trials.
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Extra resources for Statistics In Drug Research: Methodologies and Recent Developments (Biostatistics, 10)
Recently, the in vitro dissolution testing has often been considered a surrogate for in vivo bioequivalence testing, which in turn serves as a surrogate for clinical outcomes. Whentwo drug products are bioequivalent to each other, it is assumed that they reach the same therapeutic effect or that they are therapeutically equivalent. drug products be compared, in addition to the usual USPtest for dissolution. The FDArecommendsa similarity factor, which is knownas the f2 similarity factor, be evaluated to determine whether two drug products have similar dissolution profiles.
The result is useful for the determination of samplesize in planning a clinical trial to account for possible missing values in order to achieve the desired power. In some cases, information provided by auxiliary variables can be used to improve the statistical power, which is also discussed in Chapter 9. Whendropouts or missing values are related to the main response variable used to evaluate treatment effects, the evaluation of treatment effects between patients whostay and patients who drop out is necessary to provide a fair and unbiased assessment of the treatment effect.
3 Dissolution Testing For oral solid dosage forms of drug products, dissolution testing is usually conducted to assess the rate and extent of drug release. The purpose of dissolution testing is multifold. First, it is to ensure that a certain amount of the drug product will be released at a specific time point after administration in order for the drug to be efficiently delivered to the site of action for optimal therapeutic effect. Second, it is to ensure that the dissolution of the drug product meets the acceptance limits for quality assurance before the drug product is released to the marketplace.
Statistics In Drug Research: Methodologies and Recent Developments (Biostatistics, 10) by Shein-Chung Chow