عنوان
پدید آورنده
موضوع
رده
RA401.5 .D48 2008
RA401
.
5
.
D48
2008
کتابخانه
محل استقرار
0470050942 (hbk.)
9780470050941 (hbk.)
dltt
Development and approval of combination products :
[Book]
a regulatory perspective /
edited by Evan B. Siegel
Hoboken, N.J. :
Wiley,
c2008
xii, 215 p. :
ill. ;
25 cm
Includes bibliographical references and index
Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier
0
United States.
Biological products-- United States
Drug approval-- United States
Medical instruments and apparatus-- United States
Device Approval-- legislation & jurisprudence
Drug Approval-- legislation & jurisprudence
Drug Combinations
United States
2
RA401
.
5
RA401
.
5
.
D48
2008
.
D48
2008
Siegel, Evan B
20160427144516.0
مطالعه متن کتاب [Book]
Y
