Abstract：
:Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing ethambutol dihydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ethambutol dihydrochloride is a Biopharmaceutics Classification System (BCS) Class III drug with permeability properties approaching the border between BCS Class I and III. BE problems of ethambutol formulations containing different excipients and different dosages forms have not been reported and hence the risk of bioinequivalence caused by excipients is low. Ethambutol has a narrow therapeutic index related to ocular toxicity. However, as long as the prescribers' information of the test product stipulates the need for regular monitoring of ocular toxicity, the additional patient risk is deemed acceptable. It is concluded that a biowaiver can be recommended for IR solid oral dosage forms provided that the test product (a) contains only excipients present in ethambutol IR solid oral drug products approved in ICH or associated countries, for instance as presented in this paper, (b) complies with the criteria for "very rapidly dissolving" and (c) has a prescribers' information indicating the need for testing the patient's vision prior to initiating ethambutol therapy and regularly during therapy.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Becker C,Dressman JB,Amidon GL,Junginger HE,Kopp S,Midha KK,Shah VP,Stavchansky S,Barends DMdoi
10.1002/jps.21061subject
Has Abstractpub_date
2008-04-01 00:00:00pages
1350-60issue
4eissn
0022-3549issn
1520-6017pii
S0022-3549(16)32531-Xjournal_volume
97pub_type
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