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In determining bioequivalence between two products such as a commercially available Branded product and a potential to-be-marketed Generic product, pharmacokinetic studies are conducted whereby each of the preparations are administered in a cross-over study (sometimes parallel study, when a cross-over study is not feasible) to volunteer subjects, generally healthy individuals but occasionally ...
A very simple equivalence testing approach is the ‘two one-sided t-tests’ (TOST) procedure. [11] In the TOST procedure an upper (Δ U) and lower (–Δ L) equivalence bound is specified based on the smallest effect size of interest (e.g., a positive or negative difference of d = 0.3).
A study by Chuck Benbrook concluded that the spread of glyphosate-resistant weeds had increased US herbicide use. [353] [354] That study cited a 23% increase (.3 kilograms/hectare) for soybeans from 1996 to 2006, a 43% (.9 kg/ha) increase for cotton from 1996 to 2010 and a 16% (.5 kg/ha) decrease for corn from 1996 to 2010. [353]
Pharmacogenomics, often abbreviated "PGx," is the study of the role of the genome in drug response. Its name (pharmaco-+ genomics) reflects its combining of pharmacology and genomics. Pharmacogenomics analyzes how the genetic makeup of a patient affects their response to drugs. [1]
Metagenomics is the study of microbial communities directly obtained from the environment. Different from cultured microorganisms from the lab, the wild sample usually contains dozens, sometimes even thousands of types of microorganisms from their original habitats. [ 36 ]
Bioequivalence Studies in Drug Development: Methods and Applications. Statistics in Practice. Chichester, UK: John Wiley and Sons. pp. 17– 36. ISBN 978-0-470-09475-4; Chow, Shein-Chung; Liu, Jen-pei (15 October 2008). Design and Analysis of Bioavailability and Bioequivalence Studies. Biostatistics Series. Vol. 27 (3rd ed.).
Pharmacokinetics is based on mathematical modeling that places great emphasis on the relationship between drug plasma concentration and the time elapsed since the drug's administration. Pharmacokinetics is the study of how an organism affects the drug, whereas pharmacodynamics (PD) is the study of
Randomized controlled trial [5]. Blind trial [6]; Non-blind trial [7]; Adaptive clinical trial [8]. Platform Trials; Nonrandomized trial (quasi-experiment) [9]. Interrupted time series design [10] (measures on a sample or a series of samples from the same population are obtained several times before and after a manipulated event or a naturally occurring event) - considered a type of quasi ...