How to choose molecule for BE study

Dear all,

if you have funds only for one BE study, based on which characteristics would you choose between performig the study for:

  1. Valsartan 160 mg
  2. Spironolactone 50 mg
  3. Olanzapine 10 mg


Selection of molecule of the drug depends upon the following aspects and characteristics:

1 The intrasubject variability (The high intrasubject variability greater than 30%) would require, more volunteers to conduct Bioequivalence studies. Hence more expensive.

2 Also depends upon the type of formulation you have developed incorporating specified drugs. For oral solid dosage forms (tablets, Capsules) BE study is required. For parenteral BE study is not required.

3 According to the biopharmaceutics classification system, if the drug is highly soluble and highly permeable in the human body, then BE study is not required (this is a general strategy, it all depends upon other factors also.)

4 If there are many strengths of one drug (tablets/capsules) and if the formulation is linear (ratio of API and excipients is the same in all strengths then BE study of only highest strength is required while BE studies of all lower strengths is not required.

5 For all modified release, delayed-release tablets and capsules BE study is required.

6 The country in which the product is to be marketed has to be decided because the Regulatory requirements to conduct BE studies and submission of product dossiers to get marketing authorization are different in different countries. Therefore, the cost to conduct BE study will be different. In some countries, single BE study of a drug (fasting condition) is enough while in other countries 2 or 3 BE studies are required (Fasting, Fed conditions, and along with apple sauce / fruit juice) to be conducted as per Regulatory requirements (such as USFDA, EMA, MHRA-UK, ANVISA-Brazil)

7 Most important is the marketing requirements. It all depends upon which product is to be marketed should be selected first.