Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labelling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico‐legal challenges that have remained entrenched in the post‐diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information. However, there are additional pragmatic strategies, such the employment of phar...
abstract: The inherent risk in testing drugs has been hotly debated since the government first start...
Drug use during pregnancy and lactation is an almost inevitable event. Some of the drugs may have ad...
Pregnancy, childbirth and lactation pose unique challenges in terms of drug therapy. The pregnant mo...
Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historical...
In the past three decades, there has been unprecedented growth in medical research utilizing human s...
Background: The treatment of medical conditions complicating pregnancy is challenged by a serious la...
Pregnant or potentially pregnant women have historically been excluded from clinical trials of new m...
Medication use during pregnancy in the absence of pharmacokinetic and safety data is common, particu...
Evidence-based treatment for pregnant women will ultimately require research conducted in the popula...
Information on the extent of drug exposure to mothers and infants during pregnancy and lactation nor...
It is a regulatory fact that only 14 drugs are approved for use during pregnancy; none of them is sp...
Background: The treatment of medical conditions complicating pregnancy is challenged by a serious la...
The exclusion of pregnant populations, women of reproductive age, and the fetus from clinical trials...
Information on the extent of drug exposure to mothers and infants during pregnancy and lactation nor...
Information on the extent of drug exposure to mothers and infants during pregnancy and lactation nor...
abstract: The inherent risk in testing drugs has been hotly debated since the government first start...
Drug use during pregnancy and lactation is an almost inevitable event. Some of the drugs may have ad...
Pregnancy, childbirth and lactation pose unique challenges in terms of drug therapy. The pregnant mo...
Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historical...
In the past three decades, there has been unprecedented growth in medical research utilizing human s...
Background: The treatment of medical conditions complicating pregnancy is challenged by a serious la...
Pregnant or potentially pregnant women have historically been excluded from clinical trials of new m...
Medication use during pregnancy in the absence of pharmacokinetic and safety data is common, particu...
Evidence-based treatment for pregnant women will ultimately require research conducted in the popula...
Information on the extent of drug exposure to mothers and infants during pregnancy and lactation nor...
It is a regulatory fact that only 14 drugs are approved for use during pregnancy; none of them is sp...
Background: The treatment of medical conditions complicating pregnancy is challenged by a serious la...
The exclusion of pregnant populations, women of reproductive age, and the fetus from clinical trials...
Information on the extent of drug exposure to mothers and infants during pregnancy and lactation nor...
Information on the extent of drug exposure to mothers and infants during pregnancy and lactation nor...
abstract: The inherent risk in testing drugs has been hotly debated since the government first start...
Drug use during pregnancy and lactation is an almost inevitable event. Some of the drugs may have ad...
Pregnancy, childbirth and lactation pose unique challenges in terms of drug therapy. The pregnant mo...