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
1.–5. rezultāts no 100.
118. lappuse
... system for the drug product ( for example , glass to high density poly- ethylene ( HDPE ) , or HDPE to poly- vinyl chloride ) or change a specifica- tion or regulatory analytical method for the container and closure system ; ( viii ) To ...
... system for the drug product ( for example , glass to high density poly- ethylene ( HDPE ) , or HDPE to poly- vinyl chloride ) or change a specifica- tion or regulatory analytical method for the container and closure system ; ( viii ) To ...
119. lappuse
... system . ( ix ) To extend the expiration date of the drug product based on data ob- tained under a new or revised ... system for the drug product ( for example , a change from one high density polyethylene ( HDPE ) to an- other HDPE ) ...
... system . ( ix ) To extend the expiration date of the drug product based on data ob- tained under a new or revised ... system for the drug product ( for example , a change from one high density polyethylene ( HDPE ) to an- other HDPE ) ...
121. lappuse
... system for solid dosage forms , based upon a showing of equiva- lency to the approved system under a protocol approved in the application or published in an official compendium ; ( E ) A change in the size of a con- tainer for a solid ...
... system for solid dosage forms , based upon a showing of equiva- lency to the approved system under a protocol approved in the application or published in an official compendium ; ( E ) A change in the size of a con- tainer for a solid ...
395. lappuse
... system speci- fied in the monograph for the drug being tested ; ( 2 ) A suitable recording device of at least 25 - centimeter deflection ; ( 3 ) A suitable chromatographic data managing system ; and ( 4 ) An analytical column , 3 to 30 ...
... system speci- fied in the monograph for the drug being tested ; ( 2 ) A suitable recording device of at least 25 - centimeter deflection ; ( 3 ) A suitable chromatographic data managing system ; and ( 4 ) An analytical column , 3 to 30 ...
396. lappuse
... system suitability requirements de- scribed for the system suitability test in paragraph ( c ) of this section . ( c ) System suitability test . Select the system suitability requirements speci- fied in the monograph for the drug being ...
... system suitability requirements de- scribed for the system suitability test in paragraph ( c ) of this section . ( c ) System suitability test . Select the system suitability requirements speci- fied in the monograph for the drug being ...
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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