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:
- Saying that guidances are product specific is not correct because chloroquine and hydroxychloroquine are drugs not products. Products are tablets, capsules, often unknown and proprietary compositions of a drug, excipients, and manufacturing attributes (i.e. formulation and manufacturing attributes). Hence, guidances cannot be product-specific as assumed or suggested.
- 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.”
- Furthermore, it is to be noted that the product-specific guidance concept is an invalid concept in principle. Drug dissolution testing is a scale used to measure the dissolution characteristics of a product. By definition, it (scale) has to be independent of the tested items. The point being that the guidance documents cannot be restricted to one or two drug products. These have to apply 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.
- In addition, such a decision cannot be a one-time decision, as many believe, may it be taken under an emergency. It would not be possible to withdraw such a decision once taken i.e., if dissolution test alone can provide a 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).
- 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 labeled inferior. However, with the dissolution testing only, manufacturers can manufacture and promote (for local and/or international markets) their quality products with confidence.
Keep these thoughts in mind and proceed accordingly.