WHO guideline on bioequivalence?
Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits.
What is bioequivalence study protocol?
Study Objective: The objective for a bioequivalence study is that the drug bio availability from test and reference products are not statiscally different when administered to patients are subjects at same molar dose under similar experimental conditions.
How do you interpret bioequivalence results?
The currently accepted test is often called “bioequivalence”. The bioequivalence test states that we can conclude that two treatments are not different from one another if the 90% confidence interval of the ratio of a log-transformed exposure measure (AUC and/or Cmax) falls completely within the range 80-125%.
What is the acceptance criteria for bioequivalence study of test drug?
That is, for in vivo (in vitro), a test drug product is said to be bioequivalent to a reference drug product if the estimated 90% confidence interval for the ratio of geometric means of the primary PK parameters (AUC and Cmax) is totally within the bioequivalence limits of 80% to 125% (90% to 111%).
WHO guidelines Annexure 7?
World Health Organization: Geneva; 2006: Annex 7 (WHO Technical Report Series, No. 937). These guidelines provide recommendations to regulatory authorities when defining requirements for approval of multisource (generic) pharmaceutical products in their respective countries.
What is BA and BE studies?
BA/BE (Bioavailability & Bioequivalence) Studies. Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of generic version to its proprietary version of a drug or formulations of innovator drug in different clinical trial phases.
What is the difference between bioavailability and bioequivalence?
For a drug to be highly bioavailable it should be fast and completely absorbable. Bioequivalence is Just a comparison of the bioavailability of two identical products. The rate and extent of absorption is called as bioavailability. Bioequivalence is the comparison of bioavailability between two drug formulations.
How long does a bioequivalence study take?
9 days (approximately) including the wash-out period of 48 hours and the time between last blood sampling in the last period to the final examination tests.
Why be criteria is 80% to 125%?
if T is not significantly less than the R , then T/R=80/100=0.8=80%. if R is not significantly less than the R, then R/T=80/100=0.8, in other words, T/R=100/80=1.25=125%. So, that’s how the 80%-125% bioequivalence criteria are produced. This explanation is based on the concept of the equivalence.
How do you prove 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.
Who is TRS 992?
and imported, but also their possible interchangeability. In light of the various approaches in scientific and regulatory environments, the feasibility of developing a system of international comparator products was considered in the past.
What is QRM in pharma?
Quality risk management (QRM) is a process that is relevant to all countries and should provide a rationale to understand risk and mitigate it through appropriate and robust controls. It is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product.
How do you Stow a BA guideline?
A BA guideline must be stowed so that the running end pays out first. A main guideline leading from a BA entry control point should be designated ‘A’ or ‘B’ using the tallies provided for this purpose. Any main guideline tally must be attached securely to the line before the BA team enters the risk area.
What is the be guideline?
The BE guideline is the only guideline in the EU that addresses specific technical requirements for variations since there is no specific guideline similar to Scale-Up and Post Approval Changes guidelines in the US-FDA, but only a Regulation (32) and a Directive (33) about classification.
What is the European be guideline for bioequivalence?
The first BE guideline of the EU “Investigation of Bioavailability and Bioequivalence” was published in June 1992 as part of the Rules Governing Medicinal Products in the European Communities. This guideline was revised as a “Note for Guidance on the Investigation of Bioavailability and Bioequivalence,” released in July 2001 (12).
Who is informed when a BA guideline is being extended?
When the guideline is being extended, the BA team leader must inform the BA entry control operative, who will then inform the sector, operations or incident commander. This will ensure a suitable and sufficient record is maintained.