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2. Well-characterized biotechnology products: evolving to meet the needs of the 21st century. Zoon KC Dev Biol Stand; 1998; 96():3-8. PubMed ID: 9890510 [No Abstract] [Full Text] [Related]
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4. 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]
5. 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]
6. Definition of a well-characterized biotechnology product. Zoon K; Garnick R Dev Biol Stand; 1998; 96():191-7. PubMed ID: 9890531 [No Abstract] [Full Text] [Related]
7. An FDA perspective of manufacturing changes for products in human use. Durfor CN; Scribner CL Ann N Y Acad Sci; 1992 Oct; 665():356-63. PubMed ID: 1416614 [No Abstract] [Full Text] [Related]
8. Products in the U.S. pipeline. Pharmaceutical Manufacturers Association. Biotechnology (N Y); 1991 Oct; 9(10):947-9. PubMed ID: 1367805 [No Abstract] [Full Text] [Related]
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10. Medicinal products derived through biotechnology. Brinley Morgan WJ Br Vet J; 1987; 143(6):487-8. PubMed ID: 3427385 [No Abstract] [Full Text] [Related]
11. Is the drought over for pharming? Kaiser J Science; 2008 Apr; 320(5875):473-5. PubMed ID: 18436771 [No Abstract] [Full Text] [Related]
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13. Specifications from a biotechnology industry perspective. Garnick RL Dev Biol Stand; 1997; 91():31-6. PubMed ID: 9413680 [TBL] [Abstract][Full Text] [Related]
14. Biopharmaceutic equivalency and the role of the Food & Drug Administration. Hodges RM Am J Hosp Pharm; 1968 Mar; 25(3):121-7. PubMed ID: 5658859 [No Abstract] [Full Text] [Related]
15. Biogenerics: Europe takes another step forward while the FDA dives for cover. Chamberlain P Drug Discov Today; 2004 Oct; 9(19):817-20. PubMed ID: 15381127 [No Abstract] [Full Text] [Related]
16. The role of regulatory agencies and industry in assessment of the safety of drugs for use in man. United States Food and Drug Administration's viewpoint. Ley HL; Desmond FH Can Med Assoc J; 1968 Feb; 98(6):318-21. PubMed ID: 5636100 [No Abstract] [Full Text] [Related]
17. Growing pains for biopharmaceuticals. Ashton G Nat Biotechnol; 2001 Apr; 19(4):307-11. PubMed ID: 11283578 [No Abstract] [Full Text] [Related]
18. News from the 4th symposium on the analysis of well-characterized biotechnology pharmaceuticals. Zubritsky E Anal Chem; 2000 Mar; 72(5):190A-191A. PubMed ID: 10739182 [No Abstract] [Full Text] [Related]
19. The intensified drug inspection program: procedures and results. Clevenger WL Bull Parenter Drug Assoc; 1969; 23(6):263-8. PubMed ID: 5355888 [No Abstract] [Full Text] [Related]
20. Determining drug equality. Hecht A FDA Consum; 1975 Nov; 9(9):18-20. PubMed ID: 10316633 [No Abstract] [Full Text] [Related] [Next] [New Search]