263 related articles for article (PubMed ID: 21381389)
1. [Pharmaceutical product quality control and good manufacturing practices].
Hiyama Y
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2010; (128):1-16. PubMed ID: 21381389
[TBL] [Abstract][Full Text] [Related]
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. WHO Expert Committee on Specifications for Pharmaceutical Preparations.
World Health Organ Tech Rep Ser; 1999; 885():i-vi, 1-156. PubMed ID: 10352573
[TBL] [Abstract][Full Text] [Related]
4. WHO Expert Committee on Specifications for Pharmaceutical Preparations.
World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations
World Health Organ Tech Rep Ser; 2003; 908():i-viii, 1-136, back cover. PubMed ID: 12768889
[TBL] [Abstract][Full Text] [Related]
5. WHO Expert Committee on specifications for pharmaceutical preparations.
World Health Organ Tech Rep Ser; 1996; 863():1-194. PubMed ID: 8952445
[TBL] [Abstract][Full Text] [Related]
6. Control of manufacture--principles and purposes.
Luff PR
Dev Biol Stand; 1992; 79():155-8. PubMed ID: 1286749
[TBL] [Abstract][Full Text] [Related]
7. Specifications from a biotechnology industry perspective.
Garnick RL
Dev Biol Stand; 1997; 91():31-6. PubMed ID: 9413680
[TBL] [Abstract][Full Text] [Related]
8. Industry perspectives on ICH guidelines.
Rockhold FW
Stat Med; 2002 Oct; 21(19):2949-57. PubMed ID: 12325111
[TBL] [Abstract][Full Text] [Related]
9. [Technical implications on the quality standard of new drugs].
Uchiyama M
Eisei Shikenjo Hokoku; 1995; (113):135-6. PubMed ID: 8717247
[TBL] [Abstract][Full Text] [Related]
10. [Objectives and organization of the International Conference on Harmonization].
Juillet Y
Ann Pharm Fr; 1999 Mar; 57(2):137-42. PubMed ID: 10365469
[TBL] [Abstract][Full Text] [Related]
11. [ICH M4: the standardized international restration dossier or "C.T.D." (common technical document)].
de Cremiers F
Ann Pharm Fr; 1999 Mar; 57(2):143-6. PubMed ID: 10365470
[TBL] [Abstract][Full Text] [Related]
12. [Guidelines for introducing new drugs for medical use in Poland and control of their quality].
Danysz A
Pol Tyg Lek; 1984 Dec 17-31; 39(51-52):1673-4. PubMed ID: 6522321
[No Abstract] [Full Text] [Related]
13. 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]
14. Pharmacopoeia as quality codex for the manufacturers.
Soldi A
Ann Ist Super Sanita; 1975; 11(3-4):269-80. PubMed ID: 1234728
[TBL] [Abstract][Full Text] [Related]
15. International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2001 Sep; 66(186):49028-9. PubMed ID: 12358036
[TBL] [Abstract][Full Text] [Related]
16. 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]
17. Highlights of Good Manufacturing Practice in Japan.
Morita K
J Parenter Sci Technol; 1990; 44(1):35-8. PubMed ID: 2313491
[TBL] [Abstract][Full Text] [Related]
18. [Pharmaceutical quality and good manufacturing practices (author's transl)].
Traisnel
J Pharm Belg; 1980; 35(3):233-7. PubMed ID: 7400928
[No Abstract] [Full Text] [Related]
19. Enforcement of the current good manufacturing practices for solid oral dosage forms after United States v. Barr Laboratories.
Jimenez FA
Food Drug Law J; 1997; 52(1):67-82. PubMed ID: 10346711
[No Abstract] [Full Text] [Related]
20. [Changes in the norms governing practices for the manufacture of pharmaceutical products: implications for the MERCOSUR].
Temprano G; Prats S; Bregni C
Boll Chim Farm; 1998 Nov; 137(10):426-38. PubMed ID: 9880947
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]