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 100.
190. lappuse
... sufficient quantities of the orphan drug within a reasonable time to meet the needs of patients with the disease or condition for which the drug was des- ignated ; or ( 2 ) Provide the Director in writing the holder's consent for the ...
... sufficient quantities of the orphan drug within a reasonable time to meet the needs of patients with the disease or condition for which the drug was des- ignated ; or ( 2 ) Provide the Director in writing the holder's consent for the ...
199. lappuse
... sufficient frequency to permit an estimate of the rate and ex- tent of urinary excretion of the active drug ingredient or therapeutic moiety , or its metabolite ( s ) , measured . ( e ) Measurement of an acute pharma- cological effect ...
... sufficient frequency to permit an estimate of the rate and ex- tent of urinary excretion of the active drug ingredient or therapeutic moiety , or its metabolite ( s ) , measured . ( e ) Measurement of an acute pharma- cological effect ...
200. lappuse
... sufficient samples of urine should be taken to define the rate and extent of urinary excretion on 2 or more con- secutive days to establish that steady- state conditions are achieved . ( 3 ) A more complete characterization of the blood ...
... sufficient samples of urine should be taken to define the rate and extent of urinary excretion on 2 or more con- secutive days to establish that steady- state conditions are achieved . ( 3 ) A more complete characterization of the blood ...
289. lappuse
... sufficient and no greater than necessary to obtain valid meas- urement . The projected number of sub- jects shall be sufficient but no greater than necessary for the purpose of the study . The number of subjects shall also reflect the ...
... sufficient and no greater than necessary to obtain valid meas- urement . The projected number of sub- jects shall be sufficient but no greater than necessary for the purpose of the study . The number of subjects shall also reflect the ...
354. lappuse
... sufficient 2N sodium hy- droxide so that the pH will be 7.9 ± 0.1 after sterilization . Then add sufficient sterile penicillinase to each tube and proceed as directed for medium B. ( 5 ) Medium E. Use U.S.P. XVIII soy- bean - casein ...
... sufficient 2N sodium hy- droxide so that the pH will be 7.9 ± 0.1 after sterilization . Then add sufficient sterile penicillinase to each tube and proceed as directed for medium B. ( 5 ) Medium E. Use U.S.P. XVIII soy- bean - casein ...
Saturs
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339 | |
340 | |
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256 | |
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351 | |
483 | |
588 | |
593 | |
696 | |
699 | |
761 | |
826 | |
865 | |
890 | |
911 | |
949 | |
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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