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A low drug load may cause homogeneity problems. A high drug load may pose flow problems or require large capsules if the compound has a low bulk density. By the time phase III clinical trials are reached, the formulation of the drug should have been developed to be close to the preparation that will ultimately be used in the market. A knowledge ...
Druglikeness can be estimated for any molecule, and does not evaluate the actual specific effect that the drug achieves (biological activity). Simple rules are not always accurate and may unnecessarily limit the chemical space to search: many best-selling drugs have features that cause them to score low on various druglikeness indices. [7]
Lipinski's rule of five, also known as Pfizer's rule of five or simply the rule of five (RO5), is a rule of thumb to evaluate druglikeness or determine if a chemical compound with a certain pharmacological or biological activity has chemical properties and physical properties that would likely make it an orally active drug in humans.
In practice, the drug concentration is measured at certain discrete points in time and the trapezoidal rule is used to estimate AUC. In pharmacology, the area under the plot of plasma concentration of a drug versus time after dosage (called “area under the curve” or AUC) gives insight into the extent of exposure to a drug and its clearance ...
The drug apparent permeability (P app) is calculated by normalizing the drug flux (j) over the initial concentration of the API in the donor compartment (c 0) as: Equation 2: = / Dimensionally, the P app represents a velocity, and it is normally expressed in cm/sec. The highest is the permeability, the highest is expected to be the ...
A drug's characteristics make a clear distinction between tissues with high and low blood flow. Enzymatic saturation: When the dose of a drug whose elimination depends on biotransformation is increased above a certain threshold the enzymes responsible for its metabolism become saturated. The drug's plasma concentration will then increase ...
The Chinese definition of "bioequivalence" entails having the test drug's geometric mean C max, AUC (0–t), and AUC (0–∞) fall into 80%–125% of the reference drug in both fasting and fed states. The reference drug should be preferably the original brand-name drug, then (if not available) an internationally-recognized generic approved by ...
The calculation of likelihood ratios for tests with continuous values or more than two outcomes is similar to the calculation for dichotomous outcomes; a separate likelihood ratio is simply calculated for every level of test result and is called interval or stratum specific likelihood ratios.