Bye Bye – Bioequivalence testing? Long live drug dissolution testing! —– #2 (gift from heaven)

Yesterday, I posted my view on the recent FDA guidance documents for chloroquine and hydroxychloroquine (link). I do not think people realize the long term impact of this development where BE studies have been replaced/substituted with drug dissolution testing. Let me explain:

  1. Saying that guidances are product specific is not correct, because chloroquine and hydroxychloroquine are drugs not products. Products are tablets, or capsules, with often unknown and proprietary composition of a drug, excipients and manufacturing attributes (i.e. formulation and manufacturing attributes). Hence, guidances cannot be product specific as assumed or suggested.
  2. A drug dissolution test is conducted for products not drugs. As product attributes are mostly unknown and propriety, as noted above, hence a dissolution test (or guidance) cannot be product specific but has to be independent “standard or universal”.
  3. Furthermore, it is to be noted that in principle product specific guidance concept is an invalid concept. Drug dissolution testing is a scale used to measure dissolution characteristics of a product. By definition it (scale) has to be independent to the tested items. Point being that the guidance documents cannot be restricted one or two drug products. These have to be applicable to ALL highly soluble drug products. It would not be possible for authorities, at least scientifically, to defend restricting to only one or two products. This decision could easily be challenged and won.
  4. In addition, such a decision cannot be one time decision, as many believe, may it be taken under an emergency situation. It would not be possible to withdraw such a decision once taken i.e. if dissolution test alone can provide quality assessment of the products, then why would BE studies be needed and required on what basis especially when BE studies are known to be irrelevant (link).
  5. This new development is a gift from heaven for the underdeveloped countries where because of lack of BE studies, products and their manufacturing have always been labelled inferior. However, with the requirement of dissolution testing only, everyone can manufacture and promote (for local and/or international markets) their quality products with confidence.

Keep these thoughts in mind and proceed accordingly.

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