When Volume 1 (Toxicolpgy) in this series of Standard Operating Procedures was pub lished in early 1979, the FDA's Good Laboratory Practice Regulations did not have the force of United States Law, but nevertheless had a substantial impact on the conduct of toxicology in laboratories throughout the world. These Regulations are now in force, and Volume 2 (Pathology) was published later the same year. Our critics have implied that we have attempted to reduce toxicology to the level of the cookery book, or alternatively that we seek to impose our standards on others, In some sinister way ensuring…mehr
When Volume 1 (Toxicolpgy) in this series of Standard Operating Procedures was pub lished in early 1979, the FDA's Good Laboratory Practice Regulations did not have the force of United States Law, but nevertheless had a substantial impact on the conduct of toxicology in laboratories throughout the world. These Regulations are now in force, and Volume 2 (Pathology) was published later the same year. Our critics have implied that we have attempted to reduce toxicology to the level of the cookery book, or alternatively that we seek to impose our standards on others, In some sinister way ensuring that the IRI code will become the international norm. We dismiss these criticisms as arrant nonsense. The many thousands of volumes already sold worldwide can provide at best a framework for adaptation to suit local laboratory condi tions, and thus speed to GLP compliance those organisations which might otherwise have remained foundering at the starting post. If Volumes 1 and 2 of this series have con tributed anything to the conduct of toxicology it must surely be in those non-English speaking nations which, because of the international nature of pharmaceutical and chemical trading, are required by commercial pressures to be in compliance with a foreign law formulated in unfamiliar terminology and introduced for reasons that are not immediately obvious. Much has happened in the short period of time since Volumes 1 and 2 were published.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Standard Operating Procedures.- Analytical Chemistry.- SOP/MET/100 General record keeping and archiving procedures (Amendment to SOP/REC/003 and 005 for Metabolic Studies).- SOP/MET/101 Quality control procedures.- SOP/MET/501 Data collection and record keeping in analytical chemistry.- SOP/MET/502 Archiving procedures in analytical chemistry.- SOP/MET/503 Procedure for the receipt and storage of drugs and analytical standards.- SOP/MET/504 Procedure for the receipt and storage of biological samples prior to analysis.- SOP/MET/505 The approval of final analytical methods in analytical biochemistry.- SOP/MET/507 Tube labelling and datare cording during pharmacokinetic studies in animals.- SOP/MET/601 Use and maintenance of fixed-volume (Oxford) pipettes.- SOP/MET/602 Use and maintenance of "Class A" pipettes and standard flasks.- SOP/MET/604 Processing of analytical data derived from liquid or gas chromatograms or from selected ion-monitoring computer output.- In Vitro Toxicology.- SOP/DTX/101 Handling and safety procedures for in vitro mutagenicity.- SOP/DTX/102 Handling, weighing and disposal of test substances in in vitro toxicology.- SOP/DTX/103 Radioactive materials storage, handling and disposal in in vitro toxicology.- SOP/DTX/104 Microbial materials - storage, handling and disposal.- SOP/DTX/105 Tissue culture materials storage, handling and disposal.- SOP/DTX/106 Use of biological safety hoods.- SOP/DTX/107 Preparation of liver homogenates and "S-9" mix.- SOP/DTX/108 Quality control assay of liver S-9 preparations.- SOP/DTX/109 Recording of results and filing within in vitro toxicology.- SOP/DTX/110 Use of autoclaves and pressure cookers.- SOP/DTX/121 Preparation of media, quality control and storage, for use in the Ames test.- SOP/DTX/122Sterilisation of media and glassware.- SOP/DTX/123 Ames assay - plate test - and evaluation of data using Salmonella typhimurium.- SOP/DTX/124 Ames assay - pre-incubation - using Salmonella typhimurium.- SOP/DTX/125 Ames assay - vapour phase - using Salmonella typhimurium.- SOP/DTX/126 Quality control of microbial cell lines, their maintenance and storage.- SOP/DTX/127 Calibration and use of Biotran Colony Counter.- SOP/DTX/128 Use of TRP+ reversion in Escherichia coli (E. coli WP2, WP2/uvrA?, WP2/uvrA?, (PKM101) and WP100).- SOP/DTX/129 E. coli DNA-repair plate assay + evaluation of data.- SOP/DTX/130 E. coli DNA-repair test in suspension.- SOP/DTX/132 S. cerevisiae D5 recombination assay and evaluation of data.- SOP/DTX/133 Quality control of S. cerevisiae D5, its maintenance and storage.- SOP/DTX/134 S. cerevisiae D5 modified recombination assay.- SOP/DTX/135 Preparation of media, quality control and storage for use in E. coli TRP+ reversion assay.- SOP/DTX/136 Preparation of media, quality control and storage for use in the E. coli DNA repair assay.- SOP/DTX/137 Preparation of media, quality control and storage for use in S. cerevisiae D5 recombination assay.- SOP/DTX/141 Preparation of media quality control and storage-tissue culture cell maintenance.- SOP/DTX/143 BHK (baby hamster kidney) cell transformation assay.- SOP/DTX/144 Gassing and maintenance of experimental dishes.- SOP/DTX/145 Counting of viability on plastic and in agar.- SOP/DTX/146 Evaluation of cell transformation data.- SOP/DTX/147 Mouse lymphoma mutation assay.- SOP/DTX/148 Evaluation of mouse lymphoma data.- SOP/DTX/149 Assay of DNA repair in human cells.- SOP/DTX/150 Assay of DNA repair using [3H]-deoxyguanosine.- SOP/DTX/152 Assay of DNA repair by radioautography.- SOP/DTX/154Use of centrifuge, ultracentrifuges and density gradient centrifugation.- SOP/DTX/155 Cytotoxicity tests.
Standard Operating Procedures.- Analytical Chemistry.- SOP/MET/100 General record keeping and archiving procedures (Amendment to SOP/REC/003 and 005 for Metabolic Studies).- SOP/MET/101 Quality control procedures.- SOP/MET/501 Data collection and record keeping in analytical chemistry.- SOP/MET/502 Archiving procedures in analytical chemistry.- SOP/MET/503 Procedure for the receipt and storage of drugs and analytical standards.- SOP/MET/504 Procedure for the receipt and storage of biological samples prior to analysis.- SOP/MET/505 The approval of final analytical methods in analytical biochemistry.- SOP/MET/507 Tube labelling and datare cording during pharmacokinetic studies in animals.- SOP/MET/601 Use and maintenance of fixed-volume (Oxford) pipettes.- SOP/MET/602 Use and maintenance of "Class A" pipettes and standard flasks.- SOP/MET/604 Processing of analytical data derived from liquid or gas chromatograms or from selected ion-monitoring computer output.- In Vitro Toxicology.- SOP/DTX/101 Handling and safety procedures for in vitro mutagenicity.- SOP/DTX/102 Handling, weighing and disposal of test substances in in vitro toxicology.- SOP/DTX/103 Radioactive materials storage, handling and disposal in in vitro toxicology.- SOP/DTX/104 Microbial materials - storage, handling and disposal.- SOP/DTX/105 Tissue culture materials storage, handling and disposal.- SOP/DTX/106 Use of biological safety hoods.- SOP/DTX/107 Preparation of liver homogenates and "S-9" mix.- SOP/DTX/108 Quality control assay of liver S-9 preparations.- SOP/DTX/109 Recording of results and filing within in vitro toxicology.- SOP/DTX/110 Use of autoclaves and pressure cookers.- SOP/DTX/121 Preparation of media, quality control and storage, for use in the Ames test.- SOP/DTX/122Sterilisation of media and glassware.- SOP/DTX/123 Ames assay - plate test - and evaluation of data using Salmonella typhimurium.- SOP/DTX/124 Ames assay - pre-incubation - using Salmonella typhimurium.- SOP/DTX/125 Ames assay - vapour phase - using Salmonella typhimurium.- SOP/DTX/126 Quality control of microbial cell lines, their maintenance and storage.- SOP/DTX/127 Calibration and use of Biotran Colony Counter.- SOP/DTX/128 Use of TRP+ reversion in Escherichia coli (E. coli WP2, WP2/uvrA?, WP2/uvrA?, (PKM101) and WP100).- SOP/DTX/129 E. coli DNA-repair plate assay + evaluation of data.- SOP/DTX/130 E. coli DNA-repair test in suspension.- SOP/DTX/132 S. cerevisiae D5 recombination assay and evaluation of data.- SOP/DTX/133 Quality control of S. cerevisiae D5, its maintenance and storage.- SOP/DTX/134 S. cerevisiae D5 modified recombination assay.- SOP/DTX/135 Preparation of media, quality control and storage for use in E. coli TRP+ reversion assay.- SOP/DTX/136 Preparation of media, quality control and storage for use in the E. coli DNA repair assay.- SOP/DTX/137 Preparation of media, quality control and storage for use in S. cerevisiae D5 recombination assay.- SOP/DTX/141 Preparation of media quality control and storage-tissue culture cell maintenance.- SOP/DTX/143 BHK (baby hamster kidney) cell transformation assay.- SOP/DTX/144 Gassing and maintenance of experimental dishes.- SOP/DTX/145 Counting of viability on plastic and in agar.- SOP/DTX/146 Evaluation of cell transformation data.- SOP/DTX/147 Mouse lymphoma mutation assay.- SOP/DTX/148 Evaluation of mouse lymphoma data.- SOP/DTX/149 Assay of DNA repair in human cells.- SOP/DTX/150 Assay of DNA repair using [3H]-deoxyguanosine.- SOP/DTX/152 Assay of DNA repair by radioautography.- SOP/DTX/154Use of centrifuge, ultracentrifuges and density gradient centrifugation.- SOP/DTX/155 Cytotoxicity tests.
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