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" Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or... "
Statistical Design and Analysis of Stability Studies - Halaman 2
oleh Shein-Chung Chow - 2007 - 349 halaman
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Code of Federal Regulations: Containing a Codification of Documents of ...

1999 - 806 halaman
...necessarily, in association with inactive ingredients; or (4) Any component whose intended primary use is prevention of disease, or to affect the structure or any function of the body of man or other animals...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1999 - 508 halaman
...301-392)). (2) Active ingredient means any component that is intended to furnish 183-062 D-99-11 311 pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or of animals....
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The Code of Federal Regulations of the United States of America

1989 - 240 halaman
...(7) "Active ingredient" means any component that is intended to furnish 21 CFR Ch. I (4-1-89 Edition) pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals....
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Code of Federal Regulations: Containing a Codification of Documents of ...

1981 - 254 halaman
...fiber-releasing filters. (7) "Active ingredient" means any component that is intended to furnish pharmocological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure of any function of the body of man or other animals....
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Competitive Problems in the Drug Industry, Volume 21

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1971 - 304 halaman
...batch or lot of drug can be determined. (5) The term "active ingredient" means any component which is intended to furnish pharmacological activity or...in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals....
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Hearings, Reports and Prints of the Senate Select Committee on ..., Bagian 20-22

United States. Congress. Senate. Select Committee on Small Business - 1971 - 1192 halaman
...batch or lot of drug can be determined. (5) The term "active ingredient" means any component which is intended to furnish pharmacological activity or...in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals....
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Code of Federal Regulations: Containing a Codification of Documents of ...

1985 - 982 halaman
...necessarily, in association with one or more other ingredients. "Drug substance" means an active ingredient that is intended to furnish pharmacological activity...in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure of any function of the human body, but does not include...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1989 - 464 halaman
...Act (secs. 201-901, 52 Stat. 1040 et seq. as amended (21 USC 301-392)). (2) "Active ingredient" means any component that is intended to furnish pharmacological...in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man. The term includes...
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New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and ...

Ali M. Emran - 1991 - 544 halaman
...biological drug that is used in clinical investigation. Drug substance is defined as an active ingredient that is intended to furnish pharmacological activity...effect in the diagnosis, cure, mitigation, treatment or prevention of disease. . .Description of the drug substance ¿ should include: 1. Physical, chemical,...
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Environmental Law Lexicon

Nicholas A. Robinson - 2016 - 576 halaman
...accelerate the drying of plant tissue; 7 USC § 136(a) [FIFRA]. The FDA defines an active ingredient as any component that is intended to furnish pharmacological...in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. 21 CFR § 210.3(b)(7)....
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