263 related articles for article (PubMed ID: 8833961)
1. Impurities in drug substances and drug products: new approaches to quantification and qualification.
Berridge JC
J Pharm Biomed Anal; 1995 Dec; 14(1-2):7-12. PubMed ID: 8833961
[TBL] [Abstract][Full Text] [Related]
2. Toxicological overview of impurities in pharmaceutical products.
Jacobson-Kram D; McGovern T
Adv Drug Deliv Rev; 2007 Jan; 59(1):38-42. PubMed ID: 17188779
[TBL] [Abstract][Full Text] [Related]
3. Drug impurities: problems and regulations.
Pifferi G; Mannucci A
Boll Chim Farm; 1999 Nov; 138(10):500-7. PubMed ID: 10765465
[TBL] [Abstract][Full Text] [Related]
4. Overall impact of the regulatory requirements for genotoxic impurities on the drug development process.
Giordani A; Kobel W; Gally HU
Eur J Pharm Sci; 2011 May; 43(1-2):1-15. PubMed ID: 21420491
[TBL] [Abstract][Full Text] [Related]
5. International Conference on Harmonisation; revised guidance on Q3B(R) Impurities in New Drug Products; Availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2003 Nov; 68(220):64628-9. PubMed ID: 14619944
[TBL] [Abstract][Full Text] [Related]
6. Strategies for the investigation and control of process-related impurities in drug substances.
Argentine MD; Owens PK; Olsen BA
Adv Drug Deliv Rev; 2007 Jan; 59(1):12-28. PubMed ID: 17189658
[TBL] [Abstract][Full Text] [Related]
7. International Conference on Harmonisation; revised guidance on Q3A impurities in new drug substances; availability. Notice.
Food and Drug Administration, HHS
Fed Regist; 2003 Feb; 68(28):6924-5. PubMed ID: 12583358
[TBL] [Abstract][Full Text] [Related]
8. Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications.
Basak AK; Raw AS; Al Hakim AH; Furness S; Samaan NI; Gill DS; Patel HB; Powers RF; Yu L
Adv Drug Deliv Rev; 2007 Jan; 59(1):64-72. PubMed ID: 17196703
[TBL] [Abstract][Full Text] [Related]
9. Overview of genotoxic impurities in pharmaceutical development.
Bercu JP; Dobo KL; Gocke E; McGovern TJ
Int J Toxicol; 2009; 28(6):468-78. PubMed ID: 19966139
[TBL] [Abstract][Full Text] [Related]
10. Recent developments in the risk assessment of potentially genotoxic impurities in pharmaceutical drug substances.
Humfrey CD
Toxicol Sci; 2007 Nov; 100(1):24-8. PubMed ID: 17656486
[TBL] [Abstract][Full Text] [Related]
11. Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective.
Raman NV; Prasad AV; Ratnakar Reddy K
J Pharm Biomed Anal; 2011 Jun; 55(4):662-7. PubMed ID: 21193280
[TBL] [Abstract][Full Text] [Related]
12. Guidelines and pharmacopoeial standards for pharmaceutical impurities: overview and critical assessment.
Snodin DJ; McCrossen SD
Regul Toxicol Pharmacol; 2012 Jul; 63(2):298-312. PubMed ID: 22507740
[TBL] [Abstract][Full Text] [Related]
13. Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs).
Elder DP; Lipczynski AM; Teasdale A
J Pharm Biomed Anal; 2008 Nov; 48(3):497-507. PubMed ID: 18657926
[TBL] [Abstract][Full Text] [Related]
14. Guidelines from the International Conference on Harmonisation (ICH).
Branch SK
J Pharm Biomed Anal; 2005 Aug; 38(5):798-805. PubMed ID: 16076542
[TBL] [Abstract][Full Text] [Related]
15. Tablet identification using near-infrared spectroscopy (NIRS) for pharmaceutical quality control.
Alvarenga L; Ferreira D; Altekruse D; Menezes JC; Lochmann D
J Pharm Biomed Anal; 2008 Sep; 48(1):62-9. PubMed ID: 18572342
[TBL] [Abstract][Full Text] [Related]
16. Assuring quality of drugs by monitoring impurities.
Ahuja SS
Adv Drug Deliv Rev; 2007 Jan; 59(1):3-11. PubMed ID: 17218038
[TBL] [Abstract][Full Text] [Related]
17. Analytical control of genotoxic impurities in the pazopanib hydrochloride manufacturing process.
Liu DQ; Chen TK; McGuire MA; Kord AS
J Pharm Biomed Anal; 2009 Sep; 50(2):144-50. PubMed ID: 19427156
[TBL] [Abstract][Full Text] [Related]
18. Eliminating pharmaceutical impurities: Recent advances in detection techniques.
Liu DQ; Sun M; Wu L
Curr Opin Drug Discov Devel; 2010; 13(6):748-57. PubMed ID: 21061235
[TBL] [Abstract][Full Text] [Related]
19. Analytical, biopharmaceutical and regulatory evaluation of topical testosterone preparations.
Baert B; Annavarapu S; Burvenich C; De Spiegeleer B
Eur J Pharm Biopharm; 2009 May; 72(1):275-81. PubMed ID: 19026745
[TBL] [Abstract][Full Text] [Related]
20. Control and analysis of hydrazine, hydrazides and hydrazones--genotoxic impurities in active pharmaceutical ingredients (APIs) and drug products.
Elder DP; Snodin D; Teasdale A
J Pharm Biomed Anal; 2011 Apr; 54(5):900-10. PubMed ID: 21145684
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]