The application of Process Analytical Technology (PAT) principles for manufacturing of biotherapeutics proffers the prospect of ensuring consistent product quality along with increased productivity as well as substantial cost and time savings. Although this paradigm shift from a traditional, rather rigid manufacturing model to a more scientific, risk-based approach has been advocated by health authorities for almost two decades, the practical implementation of PAT in the biopharmaceutical industry is still limited by the lack of fit-for-purpose analytical methods. In this regard, most of the proposed spectroscopic techniques are sufficiently fast but exhibit deficiencies in terms of selectivity and sensitivity, while well-established offline methods, such as (ultra-)high-performance liquid chromatography, are generally considered as too slow for this task.
View Article and Find Full Text PDFWe present the complete chloroplast genome sequence of from San Juan Island, Washington. The chloroplast genome of is 192,037 bp in length, contains 244 genes, and is similar in content to is genetically distinct from from the North Atlantic Ocean.
View Article and Find Full Text PDFReports have correlated the use of estrogen for the treatment of menopausal symptoms with beneficial effects on the cardiovascular system. Molecular, biochemical, preclinical, and clinical studies have furnished a wealth of evidence in support of this outcome of estrogen action. The prospective randomized Women's Health Initiative (WHI) and the Early Versus Late Intervention Trial (ELITE) showed that starting menopausal hormone treatment (MHT) within 5 to 10 years of menopause is fundamental to the success of estrogen's cardioprotection in post-menopausal women without adverse effects.
View Article and Find Full Text PDFPrevention of osteoporosis should begin in childhood and continue throughout adulthood. Although genetic determinants of muscle and bone mass may offer other therapeutic options in the future, currently, counseling should primarily focus on lifestyle modification including healthy dietary practices and regular exercise. Vitamin supplementation, particularly vitamin D, should be considered to enhance diet based on patient's need.
View Article and Find Full Text PDFStudy Question: What do older women understand of the relationship between age and fertility prior and subsequent to delivering their first child?
Summary Answer: Women who were first-time parents over the age of 40 did not accurately perceive the relationship between age and fertility prior to conceiving with IVF.
What Is Known Already: While increases in women's age at their first birth have been most pronounced in relatively older women, the rapidity of fertility decline is not appreciated by most non-infertility specialist physicians, the general public or men and women who are delaying childbearing.
Study Design, Size And Duration: Qualitative retrospective interviews were conducted from 2009 to 2011 with 61 self-selected women who were patients in one of two fertility clinics in the USA.
Objective: To examine whether psychological distress predicts IVF treatment outcome as well as whether IVF treatment outcome predicts subsequent psychological distress.
Design: Prospective cohort study over an 18-month period.
Setting: Five community and academic fertility practices.
Objective: To determine predictors of low birth weight (LBW) and preterm delivery (PTD) in singleton pregnancies conceived by women with and without a history of infertility.
Design: Retrospective cohort study.
Setting: Eleven infertility clinics in northern California.
Background: As ages at first birth have steadily risen in the industrial west over the last several decades, the phenomenon of 'delayed childbearing' has come under research scrutiny by demographers, medical specialists and social scientists. In this study, we specifically explore the perceived advantages and disadvantages of postponed conception as well as participants' retrospective opinions on the 'optimal age' for parenting.
Methods: To this end, we examined a cohort purposely chosen to epitomize delayed childbearing, i.
Objective: To describe older parents' attitudes and opinions about the costs and insurance coverage for IVF.
Design: Qualitative interview study.
Setting: Two Northern California IVF practices.
In response to concerns from feminists, demographers, bioethicists, journalists, and health care professionals, the Indian government passed legislation in 1994 and 2003 prohibiting the use of sex selection technology and sex-selective abortion. In contrast, South Asian families immigrating to the United States find themselves in an environment where reproductive choice is protected by law and technologies enabling sex selection are readily available. Yet there has been little research exploring immigrant Indian women's narratives about the pressure they face to have sons, the process of deciding to utilize sex selection technologies, and the physical and emotional health implications of both son preference and sex selection.
View Article and Find Full Text PDFObjective: To examine resource use (costs) by women presenting for infertility evaluation and treatment over 18 months, regardless of treatment pursued.
Design: Prospective cohort study in which women were followed for 18 months.
Setting: Eight infertility practices.
Objective: The purpose of this study was to assess the effect of DT56a (Femarelle), a selective estrogen receptor modulator, on platelet function in normal and thrombophilic women being treated for severe menopausal symptoms.
Methods: The Platelet Function Analyzer-100 (PFA-100) was used to asses platelet reactivity at baseline and after 8 weeks of treatment with Femarelle (644 mg/d in divided doses) in 25 symptomatic postmenopausal women with normal clotting times and seven symptomatic women with shortened clotting times (<61 s). The PFA-100 measure of closure time is considered equal to clotting time in assessing clotting function and platelet adhesion, aggregation, and blood coagulation factors.
Objective: To determine the relationship between number of fertility treatment cycles and pregnancy rates.
Design: Prospective cohort study.
Setting: Eight community and academic infertility practices.
We studied a prospective cohort of 434 couples in Northern California and found that 13% did not pursue any form of infertility treatment after their initial consultation. Although age, education, and financial concerns remain important for patients in choosing whether to pursue infertility treatment, depressive symptoms may also be a barrier to achieving reproductive goals.
View Article and Find Full Text PDFObjective: To describe frozen embryo holders' expectations and perceptions of IVF clinic information, support, and storage fees and their relevance to embryo disposition decision making.
Design: Qualitative interview study.
Setting: Three northern California IVF practices.
Objective: To determine the prevalence of complementary and alternative medicine (CAM) use among couples seeking fertility care and to identify the predictors of CAM use in this population.
Design: Prospective cohort study.
Setting: Eight community and academic infertility practices.
In a qualitative interview study of 77 families with stored frozen embryos, we found that while embryo disposition decision making was influenced by individual life circumstances, embryo quantity/quality, personal values, embryo conceptualization, and clinic information, it was a stepwise process that could be represented as three sequential questions: (1) Will the embryos be used for additional attempts at conception? If not, (2) Will the embryos remain in storage? And if not, (3) Will the embryos be donated to other people or to science, or will they be destroyed? While almost two-thirds (63%) of participants kept their embryos in storage after 5 years, either passively through disagreement or indecision or actively to maintain embryo potential, avert feelings of loss, or as psychological or genetic "insurance," IVF clinic support and detailed information about options motivated families to make disposition decisions.
View Article and Find Full Text PDFObjective: To compare the perspectives of primary care physicians (PCPs) and physician sex-selection technology providers (SSTPs) about the ethics of sex selection.
Design: Qualitative interview study.
Setting(s): Academic, private, and HMO-based infertility and general medical practices.
Objective: We sought to determine the effects of oral versus transdermal estrogen therapy on platelet function in postmenopausal women.
Methods: Blood obtained from 84 postmenopausal women was tested for closure times using the Platelet Function Analyzer-100 before and after administration of oral or transdermal estrogen for 8 weeks.
Results: Women with normal closure times at baseline (n = 71) demonstrated no significant change after receiving estrogen therapy with oral (n = 29) or transdermal (n = 42) estrogen.
Objective: To provide insight into the experience of low-income immigrant Latino couples seeking infertility treatment.
Design: Qualitative interview study.
Setting: Infertility clinic at a university-affiliated urban public teaching hospital.
Midlife, once a focus of particular interest to gerontologists because of its implications for later life, has recently received little attention. But as new reproductive technologies have expanded in the United States, motherhood is occurring at older ages. While older motherhood is not a new social practice, what is unique is that an increasing number of women are becoming pregnant through technological means, often for the first time, at the end of their reproductive cycle.
View Article and Find Full Text PDFObjective: To describe parents' disclosure decision-making process.
Design: In-depth ethnographic interviews.
Setting: Participants were recruited from 11 medical infertility practices and 1 sperm bank in Northern California.