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, 1985 |
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463 as amended 52 Stat accurately weighed acid addition to complying agar diffusion assay amdinocillin ampicillin antibiotic approved assay as follows azlocillin batch for potency cefazolin cefonicid ceforanide chapter crystallinity cyclacillin demeclocycline described in paragraph dicloxacillin digoxin distilled water dosage forms doxycycline Drug Administration drug application drug product Food and Drug Further dilute gentamicin hetacillin hydrochloride immediate containers labeled in accordance less than 90 loss on drying lution master standard methods of assay-(1 Microbiological agar diffusion micrograms milligrams milliliter milliliter estimated nafcillin neomycin number of milligrams oxytetracycline penicillin ples polymyxin potassium phosphate preparing the sample Proceed as directed purity pyrogens represented to contain request shall contain Requests for certification Requirements for certification Results of tests sample for assay sample solution Samples required Secs sodium standard solution Standards of identity stock solution submitted Subpart tablets tests and assays Tests and methods tests except sterility tetracycline tion volumetric flask
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115. lappuse - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be, concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
130. lappuse - Administration with respect to the drug, evaluated together with the evidence available when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof...
68. lappuse - In publication of the results of his or her research, the doctor is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at...
60. lappuse - The investigator certifies that the drug will be administered only to subjects under his personal supervision or under the supervision of the following investigators responsible to him, , and that the drug will not be supplied to any other investigator or to any clinic for administration to subjects. g. The investigator certifies that he will inform any patients or any persons used as controls, or their representatives, that drugs are being used for investigational purposes, and will obtain the consent...
113. lappuse - English name and complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used as a component, the proprietary name should be followed by a complete quantitative statement of composition. Reasonable alternatives for any listed substance may be specified. If the petitioner does not himself perform all the manufacturing, processing, and packIng...
68. lappuse - ... consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.
5. lappuse - New drug substance" means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance. (h) The newness of a drug may arise by reason (among other reasons) of: (1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component. (2) The newness for...
185. lappuse - Do not drive or operate machinery while taking this medication. Do not give to children under 6 years of age or exceed the recommended dosage unless directed by physician. The reference to drowsiness is not required on preparations for the promotion of sleep or on preparations that are shown not to produce drowsiness.
56. lappuse - A statement of the methods, facilities, and controls used for the manufacturing, processing, and packing of the new drug to establish and maintain appropriate standards of identity, strength, quality, and purity as needed for safety and to give significance to clinical investigations made with the drug.
128. lappuse - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions...