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.
65. lappuse
... phases are conducted sequentially , they may overlap . These three phases of an investigation are a follows : ( a ) Phase 1. ( 1 ) Phase 1 includes the initial introduction of an investiga- tional new drug into humans . Phase 1 studies ...
... phases are conducted sequentially , they may overlap . These three phases of an investigation are a follows : ( a ) Phase 1. ( 1 ) Phase 1 includes the initial introduction of an investiga- tional new drug into humans . Phase 1 studies ...
66. lappuse
... Phase 1 investigations , FDA's review of Phases 2 and 3 submissions will also include an assessment of the scientific quality of the clinical inves- tigations and the likelihood that the investigations will yield data capable of meeting ...
... Phase 1 investigations , FDA's review of Phases 2 and 3 submissions will also include an assessment of the scientific quality of the clinical inves- tigations and the likelihood that the investigations will yield data capable of meeting ...
67. lappuse
... Phase 1 studies may be less detailed and more flexible than protocols for Phase 2 and 3 studies . Phase 1 protocols should be directed primarily at provid- ing an outline of the investigation - an estimate of the number of patients to ...
... Phase 1 studies may be less detailed and more flexible than protocols for Phase 2 and 3 studies . Phase 1 protocols should be directed primarily at provid- ing an outline of the investigation - an estimate of the number of patients to ...
68. lappuse
... Phase 1 studies that do not affect critical safety as- sessments are required to be reported to FDA only in the annual report . ( ii ) In Phases 2 and 3 , detailed proto- cols describing all aspects of the study should be submitted . A ...
... Phase 1 studies that do not affect critical safety as- sessments are required to be reported to FDA only in the annual report . ( ii ) In Phases 2 and 3 , detailed proto- cols describing all aspects of the study should be submitted . A ...
76. lappuse
... Phase 3 investiga- tions or after all clinical trials have been completed ; however , in appro- priate circumstances , a drug may be made available for treatment use dur- ing Phase 2. In the case of an imme- diately life - threatening ...
... Phase 3 investiga- tions or after all clinical trials have been completed ; however , in appro- priate circumstances , a drug may be made available for treatment use dur- ing Phase 2. In the case of an imme- diately life - threatening ...
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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