Drug product dissolution

Amidon, G. L., Lennemas, H., Shah, V. P., Crison, J. R. A. A theoretical basis for a biopharmaceutic drug classification the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 1995, 12, 413 20. 

The BCS also predicts the possibility of obtaining an in vitro/in vivo correlation. Justification of a biowaiver is based on a combination of the BCS classification of the drug substance and a drug product dissolution profile comparison. In all these instances, an anchor with a bioavailable product is established. Specifically, to obtain a biowaiver for an IR generic product ... 

Orally Administered Drug Products Dissolution Data Analysis with a View to In Vitro-ln Vivo Correlation... 

In this example, of transfer of a drug product dissolution method, the samples are independent (as test is destructive in nature) and additional variability due to different baths/standard sets are assumed to be negligible (dissolution baths were independently calibrated as per USP criteria). Based on the receiving site s familiarity with the methodology to be transferred, only one analyst/dissolution bath per site was used. The analyses were performed at USP level 2, i.e. 12 individual samples were tested. The standard deviation on 12 replicate analyses from an earlier study was 3.02 (Borman et al., 2009). The authors indicated that as this estimate is based on a limited number of replicates, it was good practice to use a pre-defined multiplier, which allows for uncertainty (Hahn and Meeker, 1991), in this case 1.255 (multiplier for... 

Amidon GL, Lennernas H, Shah VP and Crison JR (1995) A Theoretical Basis for a Biopharmaceutic Drug Classification The Correlation In Vitro Drug Product Dissolution and In Vivo Bioavailability. Pharm Res 12 pp 413-420. 

C. Determining Drug Product Dissolution Characteristics and Dissolution Profile Similarity... 

Amidon, G L, H. Lennernas, V. R Shah, and J. R. Crison. 1995. A theoretical basis for bio pharmaceutic drug classi cation The correlation iafvitro drug product dissolution anid vitro bioavailability. Pharmaceutical Research. 12 413-420. 

Amidon, GL, Lennernaes, H., Shah, V.P., and Crison, J.R. (1995). Atheoretical basis for a biopharmaceutic drugclassi cation the correlationio>fritro drug product dissolution aridvivobioavailability.Pharm. 

Noory C, Tran N, Ouderkrik L, Shah V. 2000. Steps for development of a dissolution method for sparingly water-soluble drug products. Dissolution Technol. 7(1) 16-19. 

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