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| References |
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Publications |
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Beckerman KP. Protease inhibitor treatment of HIV-1-infected
women may protect against extreme prematurity and very low birth
weight [letter]. J Infect Dis 2007;196:1270-1. |
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Beckerman K, Covington D, Clax P, Martinez-Tristani M, Seekins D,
Scheuerle A, Watts DH, Tilson H; Central Nervous System Birth
Defects and Antiretroviral Use in Pregnancy. 8th World Congress
of Perinatal Medicine in Florence, Italy, September 2007. |
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Tilson H, Doi PA, Covington DL, Parker A,Shields K, White A. The
Antiretrovirals in Pregnancy Registry A Fifteenth Anniversary
Celebration. Obstetrical & Gynecological Survey. 2007; 62
(2): 137-148. |
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Watts DH, Covington DL, Beckerman
K, Garcia P, Scheuerle A, Dominguez K, Ross B, Sacks S, Chavers S,
Tilson H. Assessing the risk of birth defects associated with
antiretroviral exposure during pregnancy. American Journal of
Obstetrics and Gynecology 2004;191:985-992. |
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Covington DL, Tilson H, Elder J, Doi PA, APR Steering Committee.
Assessing teratogenicity of antiretroviral drugs: Monitoring and
analysis plan of the Antiretroviral Pregnancy Registry.
Pharmacoepidemiology and Drug Safety 2004;13:537-545. |
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Scheuerle A, Covington DL. Clinical Review Procedures for the
Antiretroviral Pregnancy Registry. Pharmacoepidemiology and Drug
Safety 2004;13:529-536. |
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Scheuerle A, Tilson H. Birth defect classification by organ
system: A novel approach to heighten teratogenic signalling in a
pregnancy registry. Pharmacoepidemiology and Drug Safety
2002;11:465-475. |
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White A, Eldridge R, Andrews E. Birth outcomes following
zidovudine exposure in pregnant women: the Antiretroviral
Pregnancy Registry. Acta Paediatrica Supplement 1997;421:86-8. |
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White A, Andrews E, Eldridge R, Dickerson M, Tilson H, Elkins M,
Dai W, Hurn B, Alexander ER, Fox H, Garcia P, Rogers A. Birth
outcomes following zidovudine therapy in pregnant women. MMWR 1994
Jun 10;43(22):409, 415-416.
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Published Abstracts |
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Covington DL,
Tilson H, Watts H, et al. Value of Recruiting 100% Reporters in a
Pregnancy Registry: The Antiretroviral Pregnancy Registry
Experience. Pharmacoepidemiology and Drug Safety 2008;17 (Supplement
1):S228. |
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Covington DL, Tilson H, Watts, H, Beckerman KP, Zhang S, Lehman H.
Value of Recruiting “100% Reporters” in a Pregnancy Registry: The
Antiretroviral Pregnancy Registry Experience. Pharmacoepidemiology
and Drug Safety 2008;17 (Supplement 1):S294. |
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Covington DL, Tilson H, Watts, H, Sacks S, Vannappagari V. Assessing
the Safety of Antiretroviral Drugs Used during Pregnancy: Evolution
from Voluntary Registry to Post-Marketing Commitment.
Pharmacoepidemiology and Drug Safety 2007;16 (Supplement 2):S134. |
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Tilson H, Watts DH, Covington DL. Effective Use of
Supplemental Data in a Pregnancy Exposure Registry.
Pharmacoepidemiology and Drug Safety 2006; 15 (Supplement 1): S84.
(click to download the abstract) |
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Beckerman K, Covington DL, Watts H, Tilson H, APR Steering
Committee. Risk of Birth Defects Associated with Antiretroviral
Exposure During Pregnancy. American Journal of Obstetrics and
Gynecology 2004;189 (Supplement):S56. (click
to download the abstract) |
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Tilson H, Doi PA, Parker A, White A. The Antiretroviral Pregnancy
Registry: Ten Years of Progress. Pharmacoepidemiology and Drug
Safety 2003;12 (Supplement 1):S135. (click
to download the abstract) |
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Covington DL, Doi PA, Tilson H, APR Steering Committee.
Antiretroviral Pregnancy Registry conforms with FDA Guidelines for
Pregnancy Exposure Registries. Pharmacoepidemiology and Drug Safety
2003;12 (Supplement 1):S22. (click
to download the abstract) |
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Covington DL, Tilson H, Elder J, Doi PA, APR Steering Committee.
Assessing teratogenicity of antiretroviral drugs: Monitoring and
analysis plan of the Antiretroviral Pregnancy Registry.
Pharmacoepidemiology and Drug Safety 2002;11 (Supplement 1):S137. |
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Presentations |
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Beckerman K, Albano J, Martinez-Tristani M, Seekins D, David N,
Vannappagari V, Watts DH, Scheurle A, Tilson H. Preterm Birth (PTB),
low birth weight (LBW) and fetal antiretroviral (ARV) exposure:
Estimated gestational age (EGA) and birth weight data from 10022
singleton live births (LB) reported to the Antiretroviral Pregnancy
Registry (APR) 1989 through 31 January 2009. XVIII International
AIDS Society Conference (AIDS 2010), July 2010. (accepted). |
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Vannappagari V, Albano J, Tilson H, Scheuerle A, Beckerman K,
Seekins D, Storfer S, David N, Watts DH. Monitoring Birth Defects
among HIV positive, AR exposed pregnant women: 20 years of
Antiretroviral Pregnancy Registry data. XVIII International AIDS
Society Conference (AIDS 2010), July 2010. (accepted).. |
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Watts DH, Albano J, Scheuerle A, Pikis A, Tilson H, Beckerman K,
Seekins D, Scaglia F, Vannappagari V, Storfer S, David N, Hitti J.
Analysis of Trends in Detection of Chromosomal Abnormalities in the
Antiretroviral Pregnancy Registry (APR) from 1989-2009. Presented at
the National Birth Defects Prevention Network, March 2010. (click
to download the poster) |
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Beckerman K, Covington D, Domiguez K, Scheuerle A, Vannappagari V,
Watts D, Tilson H. Statistical Power of 12451 Prospective Reports to
Detect A Potential Birth Defect (BD) Increase Among Antiretroviral (ARV)
Exposed Newborns. Presented at the Society for Maternal-Fetal
Medicine 31st Annual Meeting February 2010. (click
to download the poster) |
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Vannappagari V, Covington D, Tilson H, Watts H, Beckerman K, Clax P,
Martinez M, Modan S, Bowlin S. Risk of Birth Defects Associated with
Antiretroviral Exposure During Pregnancy: Data from an International
Pregnancy Registry. Presented at the 13th International Workshop on
HIV Observational Databases, March 2009. |
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Beckerman KP, Covington D, Dominguez K, Scheuerle A, Vannappagari V,
Watts DH, Tilson H. Antiretroviral Pregnancy Registry (APR) at
10,000 Prospective Reports. Presented at the 9th International
Congress on Drug Therapy in HIV Infection 2008. |
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Covington D, Tilson H, Watts H, et al. Value of Recruiting 100%
Reporters in a Pregnancy Registry: The Antiretroviral Pregnancy
Registry Experience. Presented at the 24th International Conference
on Pharmacoepidemiology & Therapeutic Risk Management, Copenhagen,
Denmark, August 2008. |
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Beckerman K, Covington D, Clax P, Martinez-Tristani M, Seekins D,
Scheuerle A, Watts DH, Tilson H; Central Nervous System Birth
Defects and Antiretroviral Use in Pregnancy. 8th World Congress of
Perinatal Medicine in Florence, Italy, September 2007. |
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Covington D, Tilson H, Watts H, Sacks S, Vannappagari V. Assessing
the Safety of Antiretroviral Drugs Used During Pregnancy: Evolution
from Voluntary Registry to Post-Marketing Commitment. Poster
presentation at 23rd International Conference on
Pharmacoepidemiology & Therapeutic Risk Management, Quebec, Canada,
August 2007. |
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Covington D,
Roberts S, Tilson H, Watts H, Sacks S, Vannappagari V. Developing
Registries for Post-Marketing Risk Assessment: The Antiretrovial
Pregnancy Registry Experience. Poster presentation at the 43rd DIA
Conference, Atlanta, GA, June 2007 |
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Beckerman K, Watts H, Covington D, Ross B, Tilson H, Seekins D,
Piliero P. Assessing the Risk of Birth Defects and Other Poor
Pregnancy Outcomes Associated with Antiretroviral Exposure during
Pregnancy. Poster presentation at the 16th International AIDS
Conference, Toronto, Canada, August 2006. (click to download the
presentation) |
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Tilson H, Watts DH, Covington D. Effective Use of Supplemental Data
in Pregnancy Exposure Registries. Poster presentation
at the 22nd International Conference on Pharmacoepidemiology &
Therapeutic Risk Management, Lisbon, Portugal, August 2006. (click
to download presentation) |
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Ross B, Beckerman K, Doi P, Covington D, Tilson H. The
Antiretroviral Pregnancy Registry: Fifteen Years of Progress and
Fifteen
Years of Data. Accepted for poster presentation at the 54th Annual
Clinical Meeting of the American College of Obstetricians &
Gynecologists, Washington, DC, May, 2006. (click to download the
presentation) |
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Beckerman K, Watts H, Covington DL, Ross B, Scheuerle A, Seekins D,
Clax P, Martinez-Tristani M, Tilson H. Assessing the Risk of Central
Nervous Birth Defects Associated with Antiretroviral Exposure During
Pregnancy. Poster presentation at the 13th Annual Conference on
Retroviruses & Opportunities Infections, Denver, CO, February, 2006.
(click to download presentation) |
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Scheuerle A, Watts H, Covington DL, Beckerman K, Ross B, Seekins D,
Tilson H. Assessing a Potential Signal in the Antiretroviral
Pregnancy Registry. Poster presentation at the National Birth
Defects Prevention Network Annual Meeting, Arlington, VA, January,
2006. (click to download presentation) |
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Covington DL, Dominguez K, Kucik J, Watts H, Beckerman K, Ross B,
Clax P, Tilson H. Risk of Birth Defects Associated with
Antiretroviral Exposure During Pregnancy (oral presentation).
Treatment & Management of HIV Infection in United States Conference,
Atlanta, GA, September 15-18, 2005. (click to download presentation) |
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Dominguez K, Covington DL. Prospective Monitoring: the
Antiretroviral Pregnancy Registry (oral presentation). Symposium on
"Monitoring the Effects of Medication Use During Pregnancy and
Lactation". National Center on Birth Defects and Developmental
Disabilities, CDC, Atlanta, GA, December 13, 2004. |
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Beckerman K, Covington DL, Garcia P, Watts H, Ross B, Chavers S,
Sacks S, Tilson H. Association between Antiretroviral Therapy during
Pregnancy and Prematurity/Low Birth Weight. Oral presentation at the
11th Conference on Retroviruses and Opportunistic Infections, San
Francisco, CA, February 8-11, 2004. (click to download
the abstract) |
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Beckerman K, Covington DL, Watts H, Tilson H, APR Steering
Committee. Risk of Birth Defects Associated with Antiretroviral
Exposure During Pregnancy. Oral presentation at the 24th Annual
Society for Maternal-Fetal Medicine Scientific Meeting, New Orleans,
LA, February 2-7, 2004. (click to download presentation) |
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Covington DL, Doi
PA, Tilson H, APR Steering Committee. Antiretroviral Pregnancy
Registry conforms with FDA Guidelines for Pregnancy Exposure
Registries. Poster presentation at the 19th International Conference
on PharmacoEpidemiology, Philadelphia, PA, August 2003. |
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Tilson H, Doi PA, Parker A, White A. The Antiretroviral Pregnancy
Registry: Ten Years of Progress. Oral presentation at the 19th
International Conference on PharmacoEpidemiology, Philadelphia, PA,
August 2003. (click
to download abstract) |
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Covington DL, Tilson H, Elder J, Doi PA, APR Steering Committee.
Assessing teratogenicity of antiretroviral drugs: Monitoring and
analysis plan of the Antiretroviral Pregnancy Registry. Poster
presentation at the 18th International Conference on
PharmacoEpidemiology, Edinburgh, Scotland, August 2002. (click
to download presentation) |
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Garcia PM, Covington DL, Watts DH, Beckerman K, Fox HE, Parker A,
White A. Antiretroviral therapy in pregnancy: Exposure patterns over
time and the prevalence of birth defects. Poster presentation at the
XIV International AIDS Conference, Barcelona, Spain, July 2002. (click
to download presentation) |
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Garcia PM, Beckerman K, Watts DH, Fox HE, Rodriguez E, Tilson H,
Elder J. Assessing the teratogenic potential of antiretroviral
drugs: Data from the Antiretroviral Pregnancy Registry (APR). Poster
presentation at the Annual Interscience Conference on Antimicrobial
Agents and Chemotherapy, Chicago, IL, December 2001. (click
to download abstract) |
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Garcia PM, Watts DH, Fox HE, Rodriguez E, Yuen N, Schwamlein C, Doi
P. Assessing the teratogenic potential of antiretroviral drugs: Data
from the Antiretroviral Pregnancy Registry (APR). Poster
presentation at the Society of Maternal and Fetal Medicine, January
2001. (click to
download abstract) |
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Garcia P, Watts DH, Fox HE, Samelson R, Rodriguez E, Schwamlein C,
Elder J. Assessing the teratogenic potential of antiretroviral
drugs: Data from the Antiretroviral Pregnancy Registry (APR). Poster
presentation at the 7th Conference on Retroviruses and Opportunistic
Infections, January 2000. (click
to download presentation) |
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Other Publications and Presentations |
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Olmscheid B, and Zhang S. Use of Tenofovir Disoproxil Fumarate (TDF)
in Pregnancy: Findings from the Antiretroviral Pregnancy Registry
(APR). A poster presentation at the 48th Interscience Conference on
Antimicrobial Agents and Chemotherapy, Washington, DC, October 2008. (click
to download) |
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Covington DL, Doi PA, Cunnington MC, Kennedy DL, Tilson HH.
Pregnancy Registries. In: Hartzema AG, Tilson HH, Chan KA, eds.
Pharmacoepidemiology and Therapeutic Risk Management. 1st ed.
Cincinnati, OH: Harvey Whitney Books Company; 2008:439-476. |
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Covington D, Roberts SS, McKain LF. Lessons Learned in Conducting
Pregnancy Exposure Registries. Presented at the 48th Annual
Teratology Society Meeting, Monterey, CA, June 2008. |
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Roberts SS, Martinez M, Covington D, Pasley MV, Woodward WC.
Lopinavir/ritonavir in Pregnancy. Presented at the 17th
International AIDS Conference, Mexico City, August 2008. |
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Schulte J, Dominguez K, Sukalac T, Bohannon B, Fowler MG, Pediatric
Spectrum of HIV Disease Consortium. Declines in Low Birth Weight and
Preterm Birth Among Infants Who Were Born to HIV-Infected Women
During an Era of Increased Use of Maternal Antiretroviral Drugs:
Pediatric Spectrum of HIV Disease, 1989-2004. Pediatrics 2007: 119:
e900-e906. |
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Watts DH, Li D, Handelsman E, Tilson H, Paul M, Foca M, Vajaranant
M, Diaz C, Tuomala R, Thompson B. Assessment of Birth Defects
According to Maternal Therapy among Infants in the Women and Infants
Transmission Study. J Acquir Immune Defic Syndr 2007; 44: 299-305. |
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Covington DL, Roberts S, Doi P. The Impact of Awareness on
Enrollment in Pregnancy Exposure Registries. Pharmacoepidemiology
and Drug Safety 2006;15 (Supplement 1):S141. |
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Clax P, Covington DL. Antiretroviral Pregnancy Registry – A
Multi-Company Pregnancy Registry. Oral presentation at the 7th Forum
on Patient Registries, CBI, Philadelphia, September 2005 |
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Covington DL, Conner SD, Doi PA, Swinson J, Daniels EM. Risk of
birth defects associated with nelfinavir exposure during pregnancy.
Obstetrics and Gynecology 2004;103:1181-9. (click
to download) |
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Covington DL, Doi PA, Baylor M, Tilson H. The New Generation
Pregnancy Exposure Registries. Pharmacoepidemiology and Drug Safety
2004;13(Supplement 1):S43. |
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Shields KE, Wiholm BE, Hostelley LS, Striano LF, Arena SR, Sharrar
RG. Monitoring outcomes of pregnancy following drug exposure: a
company-based pregnancy registry program. Drug Safety 2004;
27(6):353-67. |
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Covington DL. Multi-product / multi-company models – The
Antiretroviral Pregnancy Registry Experience. Oral presentation at
the DIA Workshop, Pregnancy Exposure Registries: Evaluating the
Teratogenic Potential of Pharmaceutical Products used at Clinical
Doses, Washington, DC, May 24-25, 2004. |
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Doi PA. Pregnancy Registries – Where Have We Been and Where are We
Going? Then and Now. Oral presentation at the 3nd Annual CBI Patient
Registries Conference, Philadelphia, PA, September 2003. |
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Covington DL, Doi PA. Pregnancy exposure registries: Successes and
challenges. Oral presentation at the 39th Annual Meeting of the Drug
Information Association, San Antonio, TX, June 2003. |
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Conner SD, Covington DL, Doi PA, Swinson J, Daniels EM. Risk of
birth defects associated with nelfinavir exposure during pregnancy.
Poster presentation at the 10th Conference on Retroviruses and
Opportunistic Infections, Boston, MA, February 2003. (click
to download) |
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Doi PA. Pregnancy Registries – Where Have We Been and Where are We
Going? Then and Now. Oral presentation at the 2nd Annual CBI Patient
Registries Conference, Orlando, Florida, January 2002. |
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Schwamlein C. Antiretroviral Pregnancy Registry – Example of a
Long-Standing Registry. Oral presentation at the 2nd Annual CBI
Patient Registries Conference, Orlando, Florida, January 2002. |
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McGhee K, Shields K, Benson J, Beninger P, Sharrar R. Five-year
review of maternal – fetal outcomes in patients exposed to indinavir
sulfate during pregnancy. Poster presentation at the 9th Conference
on Retroviruses and Opportunistic Infections, Seattle, WA, February
2002. |
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Response from Antiretroviral Pregnancy Registry: Draft FDA Guidance
for Industry on Establishing Pregnancy Registries. Docket Number:
99D-1541. Selected APR Sponsors, written by Doi PA, December 1999. |
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Other Registry-Related References |
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Follow-Up Data Should Be Component Of Pregnancy Registry Design –
Cmte.; The Pink Sheet, vol.62, no 14, 13-14, April 3, 2000 |
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Centralized Pregnancy Registries May Benefit Small Firms Most – FDA;
The Pink Sheet, vol.62, no 55, 27, April 10, 2000. |
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Pregnant with fears, Drug registries help women stay informed; Rubin
R, USA TODAY, March 21, 2000; pg 01. |
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Weis S, et.al. Pharmacist’s Guide to Pregnancy Registry Study. APhA,
Vol. 39, No. 6, 830-4. November/December 1999. |
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