Information Resources
Links:
FDA Guidelines: These documents represent the Agency's current thinking on a particular subject
The European Agency for the Evaluation of Medicinal Products
DIA (Drug Information Association)
PSC Forms Download Site - FDA Forms
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Association for Applied Human Pharmacology
Medical (-related) Links presented by FMH
BAG Heilmittelgesetz Schweiz
Leitfaden zur Medizinprodukte-Regulierung
Files:
Code
Subject of guideline
Document Title
Number of Documents
Size
Date
File
FDA-1571
FDA Form
Investigational New Drug Application (IND)
1
form
12kb
Jan.97
FDA-1572
FDA Form
Statement of Investigator
1
form
10kb
Jan.97
FDA-2915
FDA Form
Radioactive Drug Research Committee (RDRC) Report On Research Use Of Radioactive Drug Study Summary
1
form
18kb
May98
dij018
Drug Information Journal Papers on Clinical Trials and GCP in East Asia
Clinical Trials and GCP in East Asia
1
doc
29kb
Jan.97
dij003
Drug Information
Journal Papers on Clinical Trials
and GCP in East Asia
Current Status of Clinical Trials and Good Clinical Practice in Japan
1
doc
46kb
Jan.97
140198en
EMEA Guideline
Note for Guidance on the Investigation of Bioavailability and Bioequivalence
1
doc
104kb
Dec.98
056095en
EMEA Guideline
Note for Guidance on the Investigation of Drug Interactions
1
doc
79kb
Dec.97
055395en
EMEA Guideline
Note for Guidance on Medicinal Products in the Treatment of Alzheimer's Disease
1
doc
70kb
Jul.97
056395en
EMEA Guideline
Note for guidance on Clinical Investigation of Medicinal Products in the Treatment of Parkinson's Disease
1
doc
68kb
Dec.98
023895en
EMEA Guideline
Note for Guidance on Clinical Investigation on Medicinal Products in the Treatment of Hypertension
1
doc
71kb
Nov.98
023795en
EMEA Guideline
Note for Guidance on Antiarrhythmics
1
doc
73kb
Nov.98
055995en
EMEA Guideline
Note for guidance on the Clinical Investigation of Medicinal Products in the Treatment of Schizophrenia
1
doc
68kb
Feb.98
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