Basicmedical Key

and Steven Novick2 (1) GSK, Research Triangle Park, NC, USA (2) MedImmune, Gaithersburg, MD, USA   Abstract Content Uniformity tests are used to establish that the dosage units of a drug…

Fig. 20.1 Operating characteristic (OC) curve Figure 20.1 shows a vertical line drawn at the lot percent defective value of 1.5 %. The value on the vertical axis where the vertical line crosses…

(15.1) If the investigator is concerned about some kind of departure from the model in (15.1), the center points can provide a test for such a departure, although it provides…

Fig. 17.1 Four parameter logistic regression with asymptotes A and D, 50th percentile C and slope B A model derived from Michaelis-Menten kinetics is the four-parameter logistic regression equation: (17.1)In…

’s are dissolution values of individual units expressed as a % of label claim, are averages of n individual unit dissolution values tested up to that stage, gives the number…

Fig. 11.1 Typical multi-tiered immunogenicity testing approach employed in clinical trials Screening Assay In the screening tier of immunogenicity testing, the samples responses are compared against the screening cut point….

, xi being one reportable result as an estimate of μ. Bias—or trueness—of an assay on the other hand is the difference between the average of many reportable results (i.e….

, which says that the result of any measurement, y, has two components. The first, f(x), is the signal or what the controlled factor or factors are, and the second,…

 – 2.2*s) <115 %, where and s respectively are the sample mean and the sample standard deviation of the 10 units. It fails to comply if at least 1 unit has the…

Fig. 13.1 A ray or fixed ratio design for two drugs in combination studies This design is typically used in industry for in-vitro studies. A third design (Tan et al….