跳至主要内容

Drug Bioavailability Studies from Medicilon

 Bioavailability is defined as the rate and the absorption of drug that reaches the biological system in an active form, capable of exerting the desired pharmacological effect, including its onset, intensity and duration of its action.

bioavailability studies

The Need for Bioavailability Studies

  • Bioavailability studies provide and estimate of the fraction of the orally administered dose that is absorbed into the systemic circulation when compared to the bioavailability for a solution, suspension, or intravenous dosage form that is completely available
  • Bioavailability studies provide other useful information that is important to establish dosage regimen and to support drug labeling, such as distribution and elimination characteristics of the drug
  • Bioavailability studies provide information regarding the performance of the formulation

Bioavailability Study Protocol

The aim of bioavailability study is to find out the dosage form influence on the biological performance of the drug, sensitivity to detect differences in the rate and extent of absorption.

  • Study Objective
  • Study Design
  • Methods of assessment of bioavailability plasma data and urine data acute pharmacological effect and clinical response
  • Analysis and Presentation of Data

Types of Bioavailability

  • Absolute Bioavailability – Absolute bioavailability of a drug in a formulation administered by an extravascular, including the oral route reaching the systemic circulation is the fraction of the same dose of the drug administered intravenously.
  • Relative Bioavailability – Relative bioavailability is a measure of the fraction of the given drug that is absorbed in the systemic circulation from a particular dose compared to a clinically proven standard dose of the same drug.

Assessment of Bioavailability

  • For assessing the bioavailability or clinical availability of a drug, its rate and extent of absorption and its first-pass metabolism must be evaluated.
  • These criteria are difficult or even impossible to quantify.
  • The method used to assess bioavailability depend upon the assumption that measurement of the drug concentration in a suitable body fluid, such as blood, plasma, serum, urine or sometime saliva, can be correlated with its clinical availability.

Contact Us 

Email : marketing@medicilon.com
Tel : +86 021 58591500

Tips:  Above is part of drug bioavailability studies.  You can also CONTACT US with any question or enquiry you may have. We will be happy to discuss your needs in detail and design an appropriate plan of action.

Related Articles:

Analysis on the role of drug dissolution test in the determination of human bioavailability

Three Ways to Improve the Bioavailability of Poorly Soluble Drugs

Spray Drying Method for Improving the Bioavailability of Poorly Soluble Compounds

Bioavailability research

标签：

评论

发表评论

此博客中的热门博文

What is preclinical testing?

In the process of  preclinical testing  of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a  preclinical research  phase followed, before which, as described above, the potential toxicity of the compou
发表评论
阅读全文

Inventory of the three major in vitro pharmacokinetic research methods

  The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d
发表评论
阅读全文

Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in  Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati
发表评论
阅读全文