메뉴 건너뛰기




Volumn 13, Issue 8, 2000, Pages 26-35

A brief history of the GMPs: The power of storytelling

(1)  Immel, B K a  

a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; PARACETAMOL; TRYPTOPHAN;

EID: 0033835999     PISSN: 10408304     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (7)

References (31)
  • 1
    • 0008055930 scopus 로고    scopus 로고
    • Summary of the Jungle By Upton Sinclair
    • SparkNotes Online Study Guide: (TheSpark.com Inc., Cambridge, MA)
    • (1999)
    • Ward, S.1
  • 2
    • 0008102284 scopus 로고    scopus 로고
    • Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Administration (FDA, Rockville, MD)
    • (1997)
  • 3
    • 0008057349 scopus 로고    scopus 로고
    • Office of Women's Health, FDA Milestones in Women's Health: Looking Back as We Move into the New Millennium (FDA, Rockville, MD)
    • (2000)
  • 4
    • 0008103769 scopus 로고    scopus 로고
    • FDA History: FDA Commissioners and Their Predecessors, U.S. Food and Drug Administration, Rockville, MD, rev.
    • (2000)
  • 5
    • 0008060738 scopus 로고    scopus 로고
    • Safety Assessment in Pediatrics
    • Center for Drug Evaluation and Research, U.S. Food and Drug Administration
    • (1999)
    • Roberts, R.1
  • 6
    • 0008157384 scopus 로고    scopus 로고
    • Center for Drug Evaluation and Research, Time Line: Chronology of Drug Regulation in the United States (FDA, Rockville, MD)
  • 7
    • 0003441994 scopus 로고
    • Milestones in U.S. Food and Drug Law History
    • FDA Backgrounder: Current and Useful Information from the Food and Drug Administration (FDA, Rockville, MD)
    • (1995)
  • 8
    • 0008105136 scopus 로고    scopus 로고
    • 'Jonas Salk, MD - Biography' (American Academy of Achievement), Webster's New Collegiate Dictionary (G. and C. Merriam Company, Springfield, MA, 1975)
    • (2000)
  • 10
    • 0008105137 scopus 로고    scopus 로고
    • Code of Federal Regulations, Food and Drugs, 'Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs' revised April 2000, Title 21 Part 210-211 (U.S. Printing Office, Washington, DC)
  • 11
    • 0008060739 scopus 로고    scopus 로고
    • Code of Federal Regulations, Food and Drugs, 'Medical Devices: Current Good Manufacturing Practices (CGMP) Final Rule,' revised April 1999, Title 21 Part 820 (U.S. Printing Office, Washington, DC)
  • 12
    • 0008101758 scopus 로고    scopus 로고
    • Code of Federal Regulations, Food and Drugs, 'General: Good Laboratory Practice for Nonclinical Laboratory Studies' revised April 2000, Title 21 Part 58 (U.S. Printing Office, Washington, DC)
  • 13
    • 0008102285 scopus 로고    scopus 로고
    • Protecting Against Unwanted Pregnancy: A Guide to Contraceptive Choices
    • (1997) FDA Consumer , vol.31 , Issue.3
    • Nordenberg, T.1
  • 15
    • 84862496689 scopus 로고
    • The Story of the Laws Behind the Labels, Part III: 1962 Drug Amendments
    • (1981) FDA Consumer
  • 16
    • 0008141872 scopus 로고    scopus 로고
    • Office of Special Nutritionals, Overview of Infant Formulas (FDA, Center for Food Safety and Applied Nutrition, Washington DC)
    • (1997)
  • 17
    • 0008150964 scopus 로고    scopus 로고
    • The tylenol crisis: How effective public relations saved Johnson and Johnson
    • (Penn State University Personal Web Pages, PA)
    • (1998)
    • Kaplan, T.1
  • 18
    • 0008151977 scopus 로고
    • National Center for Drugs and Biologics, 'Guide to Inspection of Computerized Systems in Drug Processing' (FDA, Rockville, MD)
    • (1983)
  • 19
    • 0008057350 scopus 로고
    • Center for Drug Evaluation and Research, 'Guideline on General Principles of Process Validation' (FDA, Rockville, MD)
    • (1987)
  • 20
    • 0008101581 scopus 로고    scopus 로고
    • Center for Food Safety and Applied Nutrition, FDA Talk Paper: Impurities Confirmed in Dietary Supplement 5-Hydroxy-L-Tryptophan (FDA, Washington, DC)
    • (1998)
  • 21
    • 0008057490 scopus 로고    scopus 로고
    • Center for Biologics Evaluation and Research, 'Draft Guidance for Industry: Manufacturing, Processing, or Holding of Active Pharmaceutical Ingredients' (FDA, Rockville, MD)
    • (1998)
  • 23
    • 0008057941 scopus 로고
    • Commissioner of Food and Drugs, Hastings Lecture (Washington, DC)
    • (1993)
    • Kessler, D.A.1
  • 24
    • 0008148045 scopus 로고    scopus 로고
    • Shiley annual hospital administrator letter: Heart valve program
    • (Pfizer Inc., New York)
    • (1998)
    • Sciacca, S.1
  • 25
    • 0008101759 scopus 로고    scopus 로고
    • Office of Regulatory Affairs, Guide to Inspections of Quality Systems (FDA Rockville. MD)
    • (1999)
  • 26
    • 0001184885 scopus 로고    scopus 로고
    • International Conference on Harmonisation, Guide for Industry: E6, Good Clinical Practice Consolidated Guidance (Geneva, Switzerland), April 1996. Published in the FederalRegister
    • (1997) , vol.62 , Issue.90 , pp. 25691-25709
  • 27
    • 0008102287 scopus 로고    scopus 로고
    • Draft Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, (FDA, Rockville, MD)
    • (1998)
  • 28
    • 0008062364 scopus 로고    scopus 로고
    • Office of Regulatory Affairs Compliance Reference: Debarment List, (FDA, Rockville, MD)
  • 30
    • 0008105140 scopus 로고    scopus 로고
    • Office of Regulatory Affairs Compliance Reference: Bioresearch Monitoring (BIMO) Disqualified/Restrictead/Assurance List for Clinical Investigators, (FDA, Rockville, MD)
  • 31
    • 0004038963 scopus 로고    scopus 로고
    • New initiatives to protect participants in Gene Therapy Trials
    • HHS Press Release, CBER (FDA, Rockville, MD)
    • (2000)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.