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Buku Buku 1 - 10 tentang 16 di Active ingredient means any component that is intended to furnish pharmacological....
" 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 - 331 halaman
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The Code of Federal Regulations of the United States of America

1982
...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 or any function of the human body, but does not include...
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The Code of Federal Regulations of the United States of America

Food and Drug Administration, U S Government Printing Office - 2001
...Act (secs. 201-901, 52 Stat. 1040 ct, seg. as amended (21 USC 301-392)). (2) Active ingredient means any component that is intended to furnish pharmacological...activity or other direct effect in the diagnosis, cure, 247 60-066 0—91 9 21 CFR Ch. I (4-1-91 Edition) mitigation, treatment, or prevention of disease,...
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The Code of Federal Regulations of the United States of America

1999
...necessarily, in association with inactive ingredients; or (4) Any component whose intended primary use is to furnish pharmacological activity or other direct...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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The Code of Federal Regulations of the United States of America

Food and Drug Administration - 2001
...(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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New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and ...

Ali M. Emran - 1991 - 520 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 - 2015 - 400 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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Validation Compliance Annual: 1995

International Validation Forum - 1995 - 1200 halaman
...filters composed of asbestos are deemed to be fiber-releasing filters. (7) 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 or other animals....
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The Code of Federal Regulations of the United States of America

Food and Drug Administration, U S Government Printing Office - 2001
...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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Strauss' Pharmacy Law and Examination Review, Fifth Edition

Steven Strauss - 2000 - 442 halaman
...batch (or any other convenient subgroups of manufactured units.) 21 CFR2!0.3|aH:OI Active Ingredient 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 or other animals....
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GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their ...

Leonard Steinborn - 2004 - 452 halaman
...in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other...in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body. API Starting Material: A...
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