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Buku Buku 1 - 10 tentang 10 di ... direct effect in the diagnosis, cure, mitigation, treatment, or prevention of....
" ... 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. The term includes those com-ponents that may undergo chemical change in the manufacture... "
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

Food and Drug Administration - 2001
...that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an active ingredient (9) In-process material...
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Validation Compliance Annual: 1995

International Validation Forum - 1995 - 1200 halaman
...that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an active ingredient. (9) In-process material...
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Ocular Theraputics and Drug Delivery

Indra K. Reddy - 1995 - 587 halaman
...that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. Astringent a locally acting pharmacological agent which, by precipitating protein, helps to clear mucus...
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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
...that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (3) Applicant means any person who submits an application or an amendment or supplement to an application...
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Strauss' Pharmacy Law and Examination Review, Fifth Edition

Steven Strauss - 2000 - 442 halaman
...that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. 21 CFR 2I0.3|jH7) Adequate Directions for Use directions under which the layman can use a drug safely...
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Pharmaceutical Computer Validation Introduction Guidebook

Daniel Farb, Bruce Gordon - 2005 - 111 halaman
...that may undergo chemical change in the manufacture of the drug product and be present in the drag product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an "active ingredient." (9) In-process material...
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Pharmaceutical Quality Control Lab Guidebook

Daniel Farb, Anthony Luttrell, Robert Kirsch - 2005 - 95 halaman
...that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an "active ingredient." (9) In-process material...
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Part 11 and Computer Validation Guidebook

Daniel Farb, Daniel Farb, M.D., Bruce Gordon - 2005 - 323 halaman
...that may undergo chemical change in the manufacture of the drug product and be present in the drag product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an "active ingredient." (9) In-process material...
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Establishing A CGMP Laboratory Audit System: A Practical Guide

David M. Bliesner - 2006 - 384 halaman
...that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (8) Inactive ingredient means any component other than an active ingredient. (9) In-process material...
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Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

Joseph D. Nally - 2016 - 424 halaman
...The term includes those components that may undergo chemical change in the manufacture of the drug product in a modified form intended to furnish the specified activity or effect. (8) "Inactive ingredient" means any component other than an "active ingredient." (9) "In-process material"...
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