Design and analysis of bioavailability and bioequivalence studies

  • How bioavailability and bioequivalence studies are conducted?

    Evaluation of bioavailability and bioequivalence studies will be based upon the measurement of concentrations of the active drug substances in the plasma with respective of time.
    In some situations, the measurements of an active or inactive metabolite may be necessary..

  • How do you conduct a bioequivalence study?

    In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations..

  • What is bioavailability study design?

    The bioavailability studies are done by measuring the concentration of the drug in the plasma or blood after administration of drug following systemic protocol of studies and documented over time..

  • What is bioequivalence study design?

    Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and PK/PD parameters.
    These studies are often done for generic drugs or when a formulation of a drug is changed during development..

  • What is the method of bioavailability study?

    Urinary drug excretion data is an indirect method for estimating bioavailability.
    The drug must be excreted in significant quantities as unchanged drug in the urine.
    In addition, timely urine samples must be collected and the total amount of urinary drug excretion must be obtained ..

  • What is the relation between bioavailability and bioequivalence?

    Bioequivalence is determined based on the relative bioavailability of the innovator medicine versus the generic medicine.
    It is measured by comparing the ratio of the pharmacokinetic variables for the innovator versus the generic medicine where equality is 1..

  • Bioavailability and Bioequivalence in Pharmaceutical Technology, Revised Edition (1st reprint) The objective of the bioavailability study is to estimate the blood plasma concentration (in ng/mcg level) of a particular drug with the help of sophisticated instruments involving HPLC.
  • Bioequivalence.
    The most common designs for bioequivalence studies are replicated crossover, nonreplicated crossover, and parallel.
    In a parallel design, each subject receives only one formulation in randomized fashion, whereas in a crossover design each subject receives different formulations in different time periods
  • For drugs excreted primarily unchanged in urine, bioavailability can be estimated by measuring the total amount of drug excreted after a single dose.
    Ideally, urine is collected over a period of 7 to 10 elimination half-lives for complete urinary recovery of the absorbed drug.
"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and Google BooksOriginally published: 1992Authors: Jen-pei Liu and Shein-Chung Chow

What is a comparative bioavailability study?

A comparative bioavailability study refers to the comparison of bioavailabilities of different formulations of the same drug or different drug products

As indicated in Chow and Liu ( 2008 ), the definition of bioavailability has evolved over time with different meanings by different individuals and organizations [ 1 ]

What is bioavailability of a drug?

1

BACKGROUND As indicated in Chapter 21 CFR (Codes of Federal Regulations) Part 320

1, bioavailability of a drug is defined as the extent and rate to which the active drug ingredient or active moiety from the drug product is absorbed and becomes available at the site of drug action

What is bioequivalence assessment?

For approval of generic drug products, the FDA requires that evidence of average bioequivalence in drug absorption be provided through the conduct of bioavailability and bioequivalence studies

Bioequivalence assessment is considered as a surrogate for clinical evaluation of the therapeutic equivalence of drug products

1 Chemistry 1 Chemistry 2

Pharmacological measurement

In pharmacology, bioavailability is a subcategory of absorption and is the fraction (%) of an administered drug that reaches the systemic circulation.

Scientific publications term

Chiral analysis refers to the quantification of component enantiomers of racemic drug substances or pharmaceutical compounds.
Other synonyms commonly used include enantiomer analysis, enantiomeric analysis, and enantioselective analysis.
Chiral analysis includes all analytical procedures focused on the characterization of the properties of chiral drugs.
Chiral analysis is usually performed with chiral separation methods where the enantiomers are separated on an analytical scale and simultaneously assayed for each enantiomer.

Categories

Bioreactor design and analysis
Design and analysis of bioavailability and bioequivalence studies pdf
Design and analysis of approximate redundant binary multipliers
Statistical design and analysis of biological experiments
Design and analysis of subgroups with biopharmaceutical applications
Design and analysis of electronic circuits gopakumar pdf
Difference between design and analysis in civil engineering
Hydraulic circuit design and analysis
Ldo circuit design and analysis an intuitive approach
Synchronous sequential circuit design and analysis
Practical transistor circuit design and analysis pdf
Practical transistor circuit design and analysis
Design and analysis of disc brake
Design and analysis of distributed algorithms
Design and analysis of disc brake project report
Design and analysis of disc brake rotor
Design and analysis of disc brake ppt
Structural design and analysis difference
Design and analysis model difference
Design and analysis of experiments eighth edition