PMID- 21402952
OWN - NLM
STAT- MEDLINE
DCOM- 20110818
LR  - 20110503
IS  - 1092-874X (Electronic)
IS  - 1091-5818 (Linking)
VI  - 30
IP  - 2
DP  - 2011 Mar
TI  - A 30-day preclinical safety evaluation study of recombinant human 
      follicle-stimulating hormone in female rhesus monkeys.
PG  - 153-61
LID - 10.1177/1091581810390823 [doi]
AB  - The objective of this study was to identify potential target organs for toxicity 
      of recombinant human follicle stimulating hormone (r-hFSH) in female rhesus 
      monkeys and to establish a no observed adverse effect level (NOAEL). In all, 24 
      female rhesus monkeys (Chinese origin, weighing 3.4-5.2 kg, approximately 5 years 
      of age) received repeated subcutaneous (sc) r-hFSH at doses of 10, 60, and 300 
      IU/kg per d or vehicle once daily for 30 days followed by a 15-day recovery 
      period. Endometrial hyperplasia and dermal edema in the external genitals were 
      found in some animals at 300 IU/kg per d. Pharmacologic-related multiple cystic 
      follicles were found in all r-hFSH-treated groups. A weak, anti-FSH antibody 
      response was detected at the end of treatment in animals administered 60 and 300 
      IU/kg per d. These results indicate that the primary effects of r-hFSH in female 
      rhesus monkeys were related to its pharmacological activity on the reproductive 
      system. The NOAEL was considered to be 60 IU/kg per d.
FAU - Cai, Yongming
AU  - Cai Y
AD  - Department of Pharmaceutical Engineering, School of Chemical and Technology, 
      Tianjin University, Tianjin, People's Republic of China.
FAU - Chen, Zhengmin
AU  - Chen Z
FAU - Zhang, Zongpeng
AU  - Zhang Z
FAU - Zhang, Longsheng
AU  - Zhang L
FAU - Li, Ming
AU  - Li M
FAU - Liu, Changxiao
AU  - Liu C
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110314
PL  - United States
TA  - Int J Toxicol
JT  - International journal of toxicology
JID - 9708436
RN  - 0 (Antibodies)
RN  - 0 (Follicle Stimulating Hormone, Human)
RN  - 0 (Gonadal Steroid Hormones)
RN  - 0 (Recombinant Proteins)
SB  - IM
MH  - Animals
MH  - Antibodies/blood
MH  - Dose-Response Relationship, Drug
MH  - Drug Evaluation, Preclinical
MH  - Endometrial Hyperplasia/pathology
MH  - Female
MH  - Follicle Stimulating Hormone, Human/*administration & dosage/*toxicity
MH  - Gonadal Steroid Hormones/blood
MH  - Injections, Subcutaneous
MH  - Macaca mulatta
MH  - No-Observed-Adverse-Effect Level
MH  - Ovarian Follicle/*drug effects
MH  - Recombinant Proteins/administration & dosage/toxicity
MH  - Toxicity Tests
EDAT- 2011/03/16 06:00
MHDA- 2011/08/19 06:00
CRDT- 2011/03/16 06:00
PHST- 2011/03/16 06:00 [entrez]
PHST- 2011/03/16 06:00 [pubmed]
PHST- 2011/08/19 06:00 [medline]
AID - 1091581810390823 [pii]
AID - 10.1177/1091581810390823 [doi]
PST - ppublish
SO  - Int J Toxicol. 2011 Mar;30(2):153-61. doi: 10.1177/1091581810390823. Epub 2011 
      Mar 14.