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.
3. Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development. Sasaki M; Hinotsu S; Kawakami K J Toxicol Sci; 2009 Oct; 34(5):493-500. PubMed ID: 19797857 [TBL] [Abstract][Full Text] [Related]
4. [Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products]. Lehmann J; Schulz RM; Sanzenbacher R Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1215-24. PubMed ID: 26431722 [TBL] [Abstract][Full Text] [Related]
5. A comparison of the U.S. EPA FIFRA GLP standards with the U.S. FDA GLP standards for nonclinical laboratory studies. Keatley KL Qual Assur; 1999; 7(3):147-54. PubMed ID: 11033740 [TBL] [Abstract][Full Text] [Related]
7. Recommended Guidelines for Developing, Qualifying, and Implementing Complex In Vitro Models (CIVMs) for Drug Discovery. Ekert JE; Deakyne J; Pribul-Allen P; Terry R; Schofield C; Jeong CG; Storey J; Mohamet L; Francis J; Naidoo A; Amador A; Klein JL; Rowan W SLAS Discov; 2020 Dec; 25(10):1174-1190. PubMed ID: 32495689 [TBL] [Abstract][Full Text] [Related]
8. Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard. Feller E Ann Ist Super Sanita; 2008; 44(4):344-7. PubMed ID: 19351993 [TBL] [Abstract][Full Text] [Related]
9. Nonclinical reproductive toxicity testing requirements for drugs, pesticides, and industrial chemicals in India and China. Rao KS; Dong J Methods Mol Biol; 2013; 947():13-30. PubMed ID: 23138892 [TBL] [Abstract][Full Text] [Related]
10. [Conducting Assured Nonclinical Studies in the Pharmaceutical Industry: Good Laboratory Practice (GLP) Study, GLP Inspection, and Standards for Assurance]. Fujikawa Y Yakugaku Zasshi; 2019; 139(6):881-885. PubMed ID: 31155530 [TBL] [Abstract][Full Text] [Related]
11. A comparison of the U.S. FIFRA GLP standards with the Japan MAFF GLP standards. Borchert J Qual Assur; 1999; 7(3):155-61. PubMed ID: 11033741 [TBL] [Abstract][Full Text] [Related]
12. Method Development and Application of an Accelerated Solution Stability Screen for Drug Discovery. Gomez-Sanchez R; Besley S; Zeliku Z; Young RJ SLAS Discov; 2020 Dec; 25(10):1191-1196. PubMed ID: 32522054 [TBL] [Abstract][Full Text] [Related]
13. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies. Andrade EL; Bento AF; Cavalli J; Oliveira SK; Schwanke RC; Siqueira JM; Freitas CS; Marcon R; Calixto JB Braz J Med Biol Res; 2016 Dec; 49(12):e5646. PubMed ID: 27982281 [TBL] [Abstract][Full Text] [Related]
14. Development of an NIH consortium for preclinicAl AssESsment of CARdioprotective therapies (CAESAR): a paradigm shift in studies of infarct size limitation. Lefer DJ; Bolli R J Cardiovasc Pharmacol Ther; 2011; 16(3-4):332-9. PubMed ID: 21821536 [TBL] [Abstract][Full Text] [Related]
15. Harmonization of rules in GLP and pharmacokinetic analysis: regulatory view. Grabowski T; Marczak M; Muszynski M; Jaroszewski JJ Bioanalysis; 2012 Feb; 4(4):417-30. PubMed ID: 22394142 [TBL] [Abstract][Full Text] [Related]
16. International GLP: a critical reflection on the harmonized global GLP standard from a test facility viewpoint. Ertz K; Preu M Ann Ist Super Sanita; 2008; 44(4):390-4. PubMed ID: 19352002 [TBL] [Abstract][Full Text] [Related]
17. Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation. de Wilde S; Veltrop-Duits L; Hoozemans-Strik M; Ras T; Blom-Veenman J; Guchelaar HJ; Zandvliet M; Meij P Cytotherapy; 2016 Jun; 18(6):797-805. PubMed ID: 27068764 [TBL] [Abstract][Full Text] [Related]
18. Mutual acceptance of data: harmonised test methods and quality assurance of data--the process explained. Koëter HB Toxicol Lett; 2003 Apr; 140-141():11-20. PubMed ID: 12676446 [TBL] [Abstract][Full Text] [Related]
19. Harmonization of good laboratory practice requirements and laboratory accreditation programs. Royal PD Qual Assur; 1994 Sep; 3(3):312-5. PubMed ID: 7804653 [TBL] [Abstract][Full Text] [Related]