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.
20. lappuse
... clinical experience or other data or in- formation necessary to make or facili- tate a determination of whether there are or may be grounds under section 505 ( e ) of the act for suspending or with- drawing approval of the application ...
... clinical experience or other data or in- formation necessary to make or facili- tate a determination of whether there are or may be grounds under section 505 ( e ) of the act for suspending or with- drawing approval of the application ...
27. lappuse
... clinical effects . 3. Atrial flutter . Digoxin slows the heart and regular sinus rhythm may appear . Fre- quently the flutter is converted to atrial fi- brillation with a slow ventricular rate . Stop- ping digoxin at this point may be ...
... clinical effects . 3. Atrial flutter . Digoxin slows the heart and regular sinus rhythm may appear . Fre- quently the flutter is converted to atrial fi- brillation with a slow ventricular rate . Stop- ping digoxin at this point may be ...
28. lappuse
... clinical situation . The patient with congestive heart failure may complain of nausea and vomiting . These symptoms may also be indications on dig- oxin intoxication . A clinical determination of the cause of these symptoms must be at ...
... clinical situation . The patient with congestive heart failure may complain of nausea and vomiting . These symptoms may also be indications on dig- oxin intoxication . A clinical determination of the cause of these symptoms must be at ...
32. lappuse
... clinical studies establishing signifi- cantly greater bioavailability than dig- oxin tablets meeting compendial re- quirements and dosage recommenda- tions based on clinical studies estab- lishing the safe and effective use of the ...
... clinical studies establishing signifi- cantly greater bioavailability than dig- oxin tablets meeting compendial re- quirements and dosage recommenda- tions based on clinical studies estab- lishing the safe and effective use of the ...
37. lappuse
... clinical inves- tigations designed to obtain evidence of safety and effectiveness . ( b ) As used in this section , the term " large volume parenteral drug prod- uct " means a terminally sterilized aqueous drug product packaged in a ...
... clinical inves- tigations designed to obtain evidence of safety and effectiveness . ( b ) As used in this section , the term " large volume parenteral drug prod- uct " means a terminally sterilized aqueous drug product packaged in a ...
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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