United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2005_register
executive
2010-09-23
article
Guidance for Industry on Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers; Availability
Notices
D09002ee1bde36f15
D09002ee1bde36f99
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.'' This guidance provides a description and basis for a process by which to select a maximum recommended starting dose (MRSD) for a first-in-human clinical trial of a therapeutic in adult healthy volunteers.
70 FR 42346
https://www.govinfo.gov/app/details/FR-2005-07-22/05-14456
05-14456
fr22jy05-63
4160-01-S
Docket No. 2002D-0492
https://www.govinfo.gov/app/details/FR-2005-07-22/05-14456
https://www.govinfo.gov/content/pkg/FR-2005-07-22/html/05-14456.htm
https://www.govinfo.gov/content/pkg/FR-2005-07-22/pdf/05-14456.pdf
1 p.
42346
42346
70 FR 42346
Guidance for Industry on Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers; Availability; Federal Register Vol. 70, Issue
NOTICE
05-14456
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2002D-0492
4160-01-S
05-14456
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.'' This guidance provides a description and basis for a process by which to select a maximum recommended starting dose (MRSD) for a first-in-human clinical trial of a therapeutic in adult healthy volunteers.
Submit written or electronic comments on agency guidances at any time.
Lois M. Freed, Center for Drug Evaluation and Research (HFD-120), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2647.
Reports and guidance documents; availability, etc.:
Initial clinical trials for therapeutics in adult healthy volunteers; maximum safe starting dosage; industry guidance,
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
Federal Register
Vol. 70, no. 140
Office of the Federal Register, National Archives and Records Administration
2005-07-22
continuing
daily
deposited
born digital
243 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2005-07-22
P0b002ee180996015
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr22jy05
https://www.govinfo.gov/app/details/FR-2005-07-22
https://www.govinfo.gov/content/pkg/FR-2005-07-22/pdf/FR-2005-07-22.pdf
https://www.govinfo.gov/content/pkg/FR-2005-07-22/xml/FR-2005-07-22.xml
fdlp
42251
42484
DGPO
2010-09-23
2023-05-03
FR-2005-07-22
machine generated
eng
FR
FR-2005-07-22
70
140