These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
4. [Technical implications on the quality standard of new drugs]. Uchiyama M. Eisei Shikenjo Hokoku; 1995; (113):135-6. PubMed ID: 8717247 [Abstract] [Full Text] [Related]
5. Statistical considerations in setting product specifications. Dong X, Tsong Y, Shen M. J Biopharm Stat; 2015; 25(2):280-94. PubMed ID: 25358110 [Abstract] [Full Text] [Related]
6. Use of a quality-by-design approach to justify removal of the HPLC weight % assay from routine API stability testing protocols. Skrdla PJ, Wang T, Antonucci V, Dowling T, Ge Z, Ellison D, Curran J, Mohan G, Wyvratt J. J Pharm Biomed Anal; 2009 Dec 05; 50(5):794-6. PubMed ID: 19596534 [Abstract] [Full Text] [Related]
9. A new approach to evaluate regression models during validation of bioanalytical assays. Singtoroj T, Tarning J, Annerberg A, Ashton M, Bergqvist Y, White NJ, Lindegardh N, Day NP. J Pharm Biomed Anal; 2006 Apr 11; 41(1):219-27. PubMed ID: 16332425 [Abstract] [Full Text] [Related]
14. Design and analysis of method equivalence studies. Borman PJ, Chatfield MJ, Damjanov I, Jackson P. Anal Chem; 2009 Dec 15; 81(24):9849-57. PubMed ID: 19925005 [Abstract] [Full Text] [Related]
15. [Observations on the specifics in the quality of drugs]. Setnikar I. Boll Chim Farm; 1968 Mar 15; 107(3):158-67. PubMed ID: 5730323 [No Abstract] [Full Text] [Related]
16. A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error. Yang H, Zhang J. PDA J Pharm Sci Technol; 2015 Mar 15; 69(6):725-35. PubMed ID: 26659103 [Abstract] [Full Text] [Related]
17. Guest editors' note: special issue on recent developments in statistical approaches for chemistry and manufacturing control (CMC) and quality-by-design(QbD). Tsong Y, Yang H. J Biopharm Stat; 2015 Mar 15; 25(2):233. PubMed ID: 25437635 [No Abstract] [Full Text] [Related]
20. Discriminatory power of the different requirements for uniformity of dosage units in the European pharmacopoeia. Limberg J, Savsek M. Pharmeur Sci Notes; 2006 Dec 15; 2006(2):45-8. PubMed ID: 17691214 [Abstract] [Full Text] [Related] Page: [Next] [New Search]