-
1
-
-
84959075371
-
-
ICH Harmonized Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for the Conduct of Human Trials and Marketing Authorization for Pharmaceuticals M3(R2)
-
ICH. ICH Harmonized Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials for the Conduct of Human Trials and Marketing Authorization for Pharmaceuticals M3(R2). 2009.
-
(2009)
-
-
-
3
-
-
84864808870
-
Contraception language in informed consent forms: a survey of biopharmaceutical companies
-
E.W.NgP.ChiruvoluG.F.LevyB.R.AllanD.F.Wyszynski. Contraception language in informed consent forms: a survey of biopharmaceutical companies. Drug Inform J. 2012;46:329–335.
-
(2012)
Drug Inform J
, vol.46
, pp. 329-335
-
-
Ng, E.W.1
Chiruvolu, P.2
Levy, G.F.3
Allan, B.R.4
Wyszynski, D.F.5
-
4
-
-
84959118126
-
-
Advisory non-binding guidance suorted by national competent authorities represented at the CTFG-meeting in Rome 2014-09-15,, UK MHRA
-
UK MHRA. Recommendations related to contraception and pregnancy testing in clinical trials. Advisory non-binding guidance supported by national competent authorities represented at the CTFG-meeting in Rome 2014-09-15. 2014.
-
(2014)
-
-
-
5
-
-
80855162690
-
-
4th ed, Geneva: Department of Reproductive Health, WHO
-
World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 4th ed. Geneva: Department of Reproductive Health, WHO; 2010.
-
(2010)
Medical Eligibility Criteria for Contraceptive Use
-
-
-
6
-
-
84906492575
-
Introduction to the HESI DART Drugs in Semen Consortium
-
C.L.ChenB.K.BeyerW.J.Breslin. Introduction to the HESI DART Drugs in Semen Consortium. Reprod Toxicol. 2014;48:113–114.
-
(2014)
Reprod Toxicol
, vol.48
, pp. 113-114
-
-
Chen, C.L.1
Beyer, B.K.2
Breslin, W.J.3
-
7
-
-
84906790980
-
Embryo-fetal exposure and developmental outcome of thalidomide following oral and intravaginal administration to pregnant rabbits
-
J.Y.HuiM.HoffmannG.Kumar. Embryo-fetal exposure and developmental outcome of thalidomide following oral and intravaginal administration to pregnant rabbits. Reprod Toxicol. 2014;48:115–123.
-
(2014)
Reprod Toxicol
, vol.48
, pp. 115-123
-
-
Hui, J.Y.1
Hoffmann, M.2
Kumar, G.3
-
8
-
-
84906789855
-
Assessment of fetal exposure risk following seminal excretion of a therapeutic IgG4 (T-IgG4) monoclonal antibody using a rabbit model
-
W.J.BreslinK.G.HilbishT.J.PageD.E.Coutant. Assessment of fetal exposure risk following seminal excretion of a therapeutic IgG4 (T-IgG4) monoclonal antibody using a rabbit model. Reprod Toxicol. 2014;48:124–131.
-
(2014)
Reprod Toxicol
, vol.48
, pp. 124-131
-
-
Breslin, W.J.1
Hilbish, K.G.2
Page, T.J.3
Coutant, D.E.4
-
9
-
-
84906790477
-
Investigation of maternal and fetal exposure to an IgG2 monoclonal antibody following biweekly intravaginal administration to cynomolgus monkeys throughout pregnancy
-
G.J.MoffatR.DaviesG.Kwon. Investigation of maternal and fetal exposure to an IgG2 monoclonal antibody following biweekly intravaginal administration to cynomolgus monkeys throughout pregnancy. Reprod Toxicol. 2014;48:132–137.
-
(2014)
Reprod Toxicol
, vol.48
, pp. 132-137
-
-
Moffat, G.J.1
Davies, R.2
Kwon, G.3
-
10
-
-
84906791817
-
The use of optical imaging to assess the potential for embryo-fetal exposure to an exogenous material after intravaginal administration
-
J.CaoX.YingB.K.BeyerA.M.DeLise. The use of optical imaging to assess the potential for embryo-fetal exposure to an exogenous material after intravaginal administration. Reprod Toxicol. 2014;48:138–147.
-
(2014)
Reprod Toxicol
, vol.48
, pp. 138-147
-
-
Cao, J.1
Ying, X.2
Beyer, B.K.3
DeLise, A.M.4
-
11
-
-
0033995864
-
Tubal sterilization: focus on the U.S. experience
-
C.WesthoffA.Davis. Tubal sterilization: focus on the U.S. experience. Fertil Steril. 2000;73:913–922.
-
(2000)
Fertil Steril
, vol.73
, pp. 913-922
-
-
Westhoff, C.1
Davis, A.2
-
12
-
-
85031987765
-
-
ICH Harmonized Tripartite Guideline: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)
-
ICH. ICH Harmonized Tripartite Guideline: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1). 2011.
-
(2011)
-
-
-
13
-
-
29444451842
-
Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide
-
M.SilvermanA.ShefferP.V.Diaz. Outcome of pregnancy in a randomized controlled study of patients with asthma exposed to budesonide. Ann Allergy Asthma Immunol. 2005;95:566–570.
-
(2005)
Ann Allergy Asthma Immunol
, vol.95
, pp. 566-570
-
-
Silverman, M.1
Sheffer, A.2
Diaz, P.V.3
-
14
-
-
84887208524
-
Understanding and using the U.S. selected practice recommendations for contraceptive use, 2013
-
ACOG Committee Opinion No. 577: Understanding and using the U.S. selected practice recommendations for contraceptive use, 2013. Obstet Gynecol. 2013;122:1132–1133.
-
(2013)
Obstet Gynecol
, vol.122
, pp. 1132-1133
-
-
-
16
-
-
84865382745
-
Clinical trial considerations on male contraception and collection of pregnancy information from female partners
-
M.L.BanholzerH.BuerginC.Wandel. Clinical trial considerations on male contraception and collection of pregnancy information from female partners. J Transl Med. 2012;10:129.
-
(2012)
J Transl Med
, vol.10
, pp. 129
-
-
Banholzer, M.L.1
Buergin, H.2
Wandel, C.3
-
17
-
-
33745107633
-
Disparities in rates of unintended pregnancy in the United States, 1994 and 2001
-
L.B.FinerS.K.Henshaw. Disparities in rates of unintended pregnancy in the United States, 1994 and 2001. Perspect Sex Reprod Health. 2006;38:90–96.
-
(2006)
Perspect Sex Reprod Health
, vol.38
, pp. 90-96
-
-
Finer, L.B.1
Henshaw, S.K.2
-
18
-
-
84959153161
-
-
London: NICE
-
National Institute for Health Care and Excellence. Long-acting reversible contraception (update). NICE Clinical Guidline 30 (Issued October 2005). London: NICE; 2014.
-
(2014)
NICE Clinical Guidline 30 (Issued October 2005)
-
-
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