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2. Characterization and establishment of specifications for biopharmaceuticals. Davis GC; Riggin RM Dev Biol Stand; 1997; 91():49-54. PubMed ID: 9413683 [TBL] [Abstract][Full Text] [Related]
3. Specifications from a biotechnology industry perspective. Garnick RL Dev Biol Stand; 1997; 91():31-6. PubMed ID: 9413680 [TBL] [Abstract][Full Text] [Related]
4. Development of specifications for biotechnology products--perspective from Europe. Trouvin JH Dev Biol Stand; 1997; 91():25-30. PubMed ID: 9413679 [No Abstract] [Full Text] [Related]
5. Global perspective on specifications for biotechnology products--perspective from Japan. Hayakawa T Dev Biol Stand; 1997; 91():15-23. PubMed ID: 9413678 [No Abstract] [Full Text] [Related]
6. In vitro - in vivo correlation: from theory to applications. Emami J J Pharm Pharm Sci; 2006; 9(2):169-89. PubMed ID: 16959187 [TBL] [Abstract][Full Text] [Related]
7. A century of dissolution research: from Noyes and Whitney to the biopharmaceutics classification system. Dokoumetzidis A; Macheras P Int J Pharm; 2006 Sep; 321(1-2):1-11. PubMed ID: 16920290 [TBL] [Abstract][Full Text] [Related]
8. Biopharmaceutics classification systems for new molecular entities (BCS-NMEs) and marketed drugs (BCS-MD): theoretical basis and practical examples. Papadopoulou V; Valsami G; Dokoumetzidis A; Macheras P Int J Pharm; 2008 Sep; 361(1-2):70-7. PubMed ID: 18614303 [TBL] [Abstract][Full Text] [Related]
9. [Dissolution tests for oral formulas containing active principles slightly soluble in water]. Bertolotti F; De Leo S; Fontani F; Sekules G Boll Chim Farm; 1973 Mar; 112(3):163-9. PubMed ID: 4721640 [No Abstract] [Full Text] [Related]
10. Drug product quality. J Am Pharm Assoc; 1970 Feb; 10(2):107-16. PubMed ID: 5411068 [No Abstract] [Full Text] [Related]
11. Use of physiologically relevant biopharmaceutics tools within the pharmaceutical industry and in regulatory sciences: Where are we now and what are the gaps? Flanagan T; Van Peer A; Lindahl A Eur J Pharm Sci; 2016 Aug; 91():84-90. PubMed ID: 27283487 [TBL] [Abstract][Full Text] [Related]
12. Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report. Mitra A; Suarez-Sharp S; Pepin XJH; Flanagan T; Zhao Y; Kotzagiorgis E; Parrott N; Sharan S; Tistaert C; Heimbach T; Zolnik B; Sjögren E; Wu F; Anand O; Kakar S; Li M; Veerasingham S; Kijima S; Lima Santos GM; Ning B; Raines K; Rullo G; Mandula H; Delvadia P; Dressman J; Dickinson PA; Babiskin A J Pharm Sci; 2021 Feb; 110(2):594-609. PubMed ID: 33152375 [TBL] [Abstract][Full Text] [Related]
13. FDA perspective on specifications for biotechnology products--from IND to PLA. Murano G Dev Biol Stand; 1997; 91():3-13. PubMed ID: 9413677 [TBL] [Abstract][Full Text] [Related]
14. In vitro drug release rate as a standard requirement. Láng B Pharmazie; 1971 Nov; 26(11):661-4. PubMed ID: 5154319 [No Abstract] [Full Text] [Related]
16. Drug product quality. Exp Med Surg; 1971; 29(1):135-44. PubMed ID: 5147595 [No Abstract] [Full Text] [Related]
17. Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. Lindenberg M; Kopp S; Dressman JB Eur J Pharm Biopharm; 2004 Sep; 58(2):265-78. PubMed ID: 15296954 [TBL] [Abstract][Full Text] [Related]
18. Parenteral suspensions. Nash RA Bull Parenter Drug Assoc; 1972; 26(2):91-4. PubMed ID: 5012208 [No Abstract] [Full Text] [Related]
19. Quality control of pharmaceutical preparations and the Third World. Summers RS Cent Afr J Med; 1983 Dec; 29(12):247-9. PubMed ID: 6671214 [No Abstract] [Full Text] [Related]
20. [How to assure the quality of a medicinal product ]. Agosti ME Medicina (B Aires); 2003; 63(5):450-2. PubMed ID: 14628657 [No Abstract] [Full Text] [Related] [Next] [New Search]