Bioavailability/Bioequivalence Detection, Lecture notes of Medical Biochemistry

Bioavailability refers to the extent and rate at which the active pharmaceutical ingredients or active parts of the drugs are absorbed and available at the site of action of the drug action. It is an indicator reflecting the degree and speed of absorption of the active ingredient into the body and has become an important means to evaluate the quality of preparations.

Typology: Lecture notes

2019/2020

Uploaded on 11/02/2021

cdformulation
cdformulation 🇺🇸

5

(2)

62 documents

1 / 3

Toggle sidebar

This page cannot be seen from the preview

Don't miss anything!

bg1
Bioavailability/Bioequivalence Detection
Bioavailability refers to the extent and rate at which the active pharmaceutical
ingredients or active parts of the drugs are absorbed and available at the site of action
of the drug action. It is an indicator reflecting the degree and speed of absorption of
the active ingredient into the body and has become an important means to evaluate the
quality of preparations. It is generally divided into absolute bioavailability and
relative bioavailability. Absolute bioavailability refers to the relative amount of the
active ingredient of the drug absorbed into the body circulation obtained by
intravenous preparations (usually considered as 100% ) as the reference preparations;
relative bioavailability refers to the relative amount of active ingredients absorbed
into the systemic circulation by preparations administered by other nonintravenous
routes (such as tablets and oral solutions). If the bioavailability of two drug products
is similar, the drug products are called bioequivalent.
CD Formulation laboratory is cGMP-compliant and equipped with state of the art
analytical instruments. We have experienced analysis experts who can work with our
formulation and manufacturing team to provide you with
bioavailability/ bioequivalence detection services. Our scientists develop and utilize
robust bioanalytical methods for evaluating the bioavailability/bioequivalence of your
drugs, and our data is accurate and reproducibility, which can help you to conduct an
appropriate risk assessment of the finished drug.
pf3

Partial preview of the text

Download Bioavailability/Bioequivalence Detection and more Lecture notes Medical Biochemistry in PDF only on Docsity!

Bioavailability/Bioequivalence Detection

Bioavailability refers to the extent and rate at which the active pharmaceutical ingredients or active parts of the drugs are absorbed and available at the site of action of the drug action. It is an indicator reflecting the degree and speed of absorption of the active ingredient into the body and has become an important means to evaluate the quality of preparations. It is generally divided into absolute bioavailability and relative bioavailability. Absolute bioavailability refers to the relative amount of the active ingredient of the drug absorbed into the body circulation obtained by intravenous preparations (usually considered as 100% ) as the reference preparations; relative bioavailability refers to the relative amount of active ingredients absorbed into the systemic circulation by preparations administered by other nonintravenous routes (such as tablets and oral solutions). If the bioavailability of two drug products is similar, the drug products are called bioequivalent.

CD Formulation laboratory is cGMP-compliant and equipped with state of the art analytical instruments. We have experienced analysis experts who can work with our formulation and manufacturing team to provide you with bioavailability/ bioequivalence detection services. Our scientists develop and utilize robust bioanalytical methods for evaluating the bioavailability/bioequivalence of your drugs, and our data is accurate and reproducibility, which can help you to conduct an appropriate risk assessment of the finished drug.

Our Methods of Bioavailability/Bioequivalence Detection

The research method with pharmacokinetic parameters as the endpoint is the commonly used bioequivalence research method. A complete bioequivalence study includes biological sample analysis, experimental design, statistical analysis and result evaluation.

 Pharmacokinetic studies

 Clinical comparison trial

In vitro studies

Methods of Biological Sample Analysis

Type Methods Application

Chromatography

Gas chromatography (GC)

Most drugs detection

High performance liquid chromatography (HPLC)

Chromatography-mass spectrometry (LC-MS, LC-MS-MS, GC-MS, GC- MS-MS)

Radioimmunoassay