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Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form .
Pharmaceutics deals with the formulation of a pure drug substance into a dosage form. Pure drug substances are usually white crystalline or amorphous powders. Before the advent of medicine as a science, it was common for pharmacists to dispense drugs as is. Most drugs today are administered as parts of a dosage form.
A clinical formulation, also known as case formulation and problem formulation, is a theoretically-based explanation or conceptualisation of the information obtained from a clinical assessment. It offers a hypothesis about the cause and nature of the presenting problems and is considered an adjunct or alternative approach to the more ...
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 ...
For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
The term dosage form may also sometimes refer only to the pharmaceutical formulation of a drug product's constituent substances, without considering its final configuration as a consumable product (e.g., capsule, patch, etc.). Due to the somewhat ambiguous nature and overlap of these terms within the pharmaceutical industry, caution is ...
The FDA considers two products bioequivalent if the 90% CI of the relative mean C max, AUC (0–t) and AUC (0–∞) of the test (e.g. generic formulation) to reference (e.g. innovator brand formulation) should be within 80% to 125% in the fasting state. Although there are a few exceptions, generally a bioequivalent comparison of Test to ...
There are three typical situations where dissolution testing plays a vital role: (i) formulation and optimization decisions: during product development, for products where dissolution performance is a critical quality attribute, both the product formulation and the manufacturing process are optimized based on achieving specific dissolution targets.