In-vitro & In-vivo Bioequivalence studies
In-Vivo Bioequivalence studies:
The following sequence of criteria is beneficial in assessing the requirement for in vivo studies:
1. Oral immediate-release merchandise with general action- Indicated for serious conditions requiring assured response. Narrow therapeutic margin. Pharmacokinetics difficult by absorption seventy nada. Unfavourable physiochemical properties, e.g. low solubility, metastable modification, instability, etc. Documented evidence for bioavailability problems. No relevant information on the market, unless justification by somebody that in vivo study isn't necessary.
2. Non-oral immediate-release products.
3. Modified-release products with systemic action
In vivo bioequivalence studies are conducted with in usual manner as mentioned for bioavailability studies, i.e. the pharmacokinetic and the pharmacodynamic methods.
In-vitro Bioequivalence studies:
1. The drug product differs solely in strength of the active substance It contains, provided all the subsequent conditions hold.
2. The drug product has been slightly reformulated, or the manufacturing technique has been slightly modified by the initial manufacturer in ways in which during which can convincingly be argued to be impertinent for the bioavailability.
3. The drug product meets all the following necessities
4. a suitable IVIVC and therefore the in vitro dissolution rate of the new product is equivalent there upon of the already approved healthful product.
- Track 1-1 Pharmacodynamics Methods
- Track 2-2 IVIVC (In-Vitro In-Vivo Correlation)
- Track 3-3 Pharmacodynamics Methods
- Track 4-4 IVIVR (In-Vitro In-Vivo Relation)