The following comments are noted from one of my earlier posts, as reported in the FDA transcripts (link):
(1) “It is noted that literally 50 percent of the batches are thrown out every year because of dissolution failures, …”
(2) “There is no evidence that the products out there on the market are bad products. There is no evidence that the agency has done a bad job in serving as a surrogate for ensuring good quality products for the consumer. And, there is no evidence that industry is not focused on quality as an important attribute to manufacturing products.”
Putting these two together clearly shows that we are dealing with the problem of dissolution and not of products or industry? Please click here for the complete post