Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1998 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
No grāmatas satura
6.–10. rezultāts no 94.
35. lappuse
... determination of pericardial effu- sions . Lung scans . lodine 125 Do Do Do human serum al- bumin . lodide lodinated human serum albumin . Rose Bengal lodopyracet , sodium iodohippurate , so- dium diatrizoate , diatrizoate methyl ...
... determination of pericardial effu- sions . Lung scans . lodine 125 Do Do Do human serum al- bumin . lodide lodinated human serum albumin . Rose Bengal lodopyracet , sodium iodohippurate , so- dium diatrizoate , diatrizoate methyl ...
65. lappuse
... determination 30 days after FDA receives the IND or earlier . [ 52 FR 8831 , Mar. 19 , 1987 , as amended at 61 FR 51529 , Oct. 2 , 1996 ; 62 FR 32479 , June 16 , 1997 ] § 312.21 Phases of an investigation . An IND may be submitted for ...
... determination 30 days after FDA receives the IND or earlier . [ 52 FR 8831 , Mar. 19 , 1987 , as amended at 61 FR 51529 , Oct. 2 , 1996 ; 62 FR 32479 , June 16 , 1997 ] § 312.21 Phases of an investigation . An IND may be submitted for ...
67. lappuse
... determining dose — and should specify in detail only those elements of the study that are critical to safety , such as necessary monitoring of vital signs and blood chemistries . Modifications of 67 Food and Drug Administration , HHS § ...
... determining dose — and should specify in detail only those elements of the study that are critical to safety , such as necessary monitoring of vital signs and blood chemistries . Modifications of 67 Food and Drug Administration , HHS § ...
68. lappuse
... determining the dose ( s ) to be administered , the planned maximum dosage , and the duration of individual patient exposure to the drug . A description of the observations and measurements to be made to fulfill the objectives of the ...
... determining the dose ( s ) to be administered , the planned maximum dosage , and the duration of individual patient exposure to the drug . A description of the observations and measurements to be made to fulfill the objectives of the ...
74. lappuse
... determination is made . ( 4 ) Results of a sponsor's investiga- tion of other safety information shall be submitted , as appropriate , in an in- formation amendment or annual re- port . ( e ) Disclaimer . A safety report or other ...
... determination is made . ( 4 ) Results of a sponsor's investiga- tion of other safety information shall be submitted , as appropriate , in an in- formation amendment or annual re- port . ( e ) Disclaimer . A safety report or other ...
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abbre abbreviated application abbreviated new drug acid active ingredient adverse drug experience agency amended antibiotic application or abbreviated bacitracin bioavailability bioequivalence cation Center for Drug certification chapter clinical hold clinical investigation conducted control number copy Cosmetic Act digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing drug substance Evaluation and Research Federal Food Food and Drug graph gredients hearing hydrochloride identified information requirements ap insulin intended inves investigational new drug labeling manufacturer marketing meet ment milligrams milliliters misbranded neomycin notice oral dosage orphan drug OTC drug product package paragraph percent person plication polymyxin proposed protocol recognized as safe reference listed drug request safe and effective safety section 502 Sodium sponsor statement submission Subpart sulfate tained tigational tion tive treatment treatment IND vestigational viated warning