(Q36707031)

15 August 2017

Women's involvement in clinical trials: historical perspective and future implications (English)

1 reference

15 August 2017

Katherine A Liu

1

1 reference

PMCID

4800017

15 August 2017

Natalie A Dipietro Mager

series ordinal

2

1 reference

15 August 2017

1 January 2016

1 reference

15 August 2017

1 reference

15 August 2017

14

1 reference

15 August 2017

1

1 reference

15 August 2017

708

1 reference

Participation of women and sex analyses in late-phase clinical trials of new molecular entity drugs and biologics approved by the FDA in 2007-2009.

15 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Adverse effects in women: implications for drug development and regulatory policies

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress?

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Preventive ethics for including women of childbearing potential in clinical trials

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Women's health and clinical trials

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999.

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Sex, gender, and health: the need for a new approach

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Gender differences in pharmacokinetics and pharmacodynamics

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

From bench to bedside: role of gender-based therapeutics in the clinical care of women

30 September 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Participation of women in clinical trials of drug therapies: a context for the controversies.

28 June 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs; notice.

5 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Promoting adherence and retention to clinical trials in special populations: a women's health initiative workshop

5 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Gender representation in trials

5 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4800017

Investigational new drug applications; amendment to clinical hold regulations for products intended for life-threatening diseases and conditions. Food and Drug Administration, HHS. Final rule

5 September 2018

1 reference

12 December 2020

Gender-based differences in the toxicity of pharmaceuticals--the Food and Drug Administration's perspective

1 reference

12 December 2020

Sex and gender factors in medical studies: implications for health and clinical practice

1 reference

12 December 2020

Advancing women's health via FDA Critical Path Initiative

1 reference

12 December 2020

Investigational new drug applications and new drug applications--FDA. Final rule

1 reference

12 December 2020

10.18549/PHARMPRACT.2016.01.708

Identifiers

DOI

1 reference

15 August 2017

1 reference

15 August 2017

1 reference

PMCID

4800017