Maternal-Fetal Drug Development: An Industry Perspective.

Medicines and vaccines prescribed to pregnant women often have not had pregnant women or lactating women included in clinical trials and products are often not approved by regulatory agencies for use in pregnant women. As a result, practitioners may need to prescribe medicines and give vaccines to this special population with limited drug efficacy and safety information available. Multiple regulatory guidance documents regarding the development of medications for pregnant and lactating women have been developed to encourage drug development and the investigation of medicines and vaccines used in this population.

Methylphenidate extended-release oral suspension for the treatment of attention-deficit/hyperactivity disorder: a practical guide for pharmacists.

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental condition that affects children, adolescents, and adults worldwide. The purpose of this review was to inform pharmacists of the numerous options to treat ADHD, with a focus on one of the more recently approved formulations, methylphenidate extended-release oral suspension (MEROS). Symptoms of ADHD can negatively impact an individual's health and quality of life and impair function in multiple settings.

Enhancing clinical trial development for pediatric kidney diseases.

The conduct of clinical trials in small pediatric subspecialties such as pediatric nephrology is hampered by both clinical demands on the pediatric nephrologist and the small number of appropriate patients available for such studies. The American Society of Pediatric Nephrology Therapeutics Development Committee (TDC) was established to (1) identify the various stakeholders with interests and/or expertise related to clinical trials in children with kidney disease and (2) develop more effective partnerships among all parties regarding strategies for successful clinical trial development and execution. This article discusses the rationale, structure, and function of the TDC, the status of progress toward its goals, and the insights gained to date that may be useful for other subspecialties that face similar challenges.

Comparison of pharmacokinetic variability of fesoterodine vs. tolterodine extended release in cytochrome P450 2D6 extensive and poor metabolizers.

What Is Already Known About This Subject: Tolterodine and 5-hydroxymethyl tolterodine (5-HMT) are equipotent active moieties of tolterodine; 5-HMT is the singular active moiety of fesoterodine. The formation of 5-HMT from tolterodine occurs via CYP2D6, and some subjects are poor metabolizers CYP2D6. On the other hand, the formation of 5-HMT from fesoterodine occurs via ubiquitous esterases.

Outcomes of a multidisciplinary partnership to improve cardiac wellness: an opportunity for pharmacists.

Objective: To describe the results of an initiative to create awareness of coronary heart disease and provide education regarding cardiovascular (CV) risk and cholesterol (lipid) management in a community-based senior population. A multidisciplinary partnership composed of governmental agencies, a member of the pharmaceutical industry, a college of pharmacy, and several community-based health care practitioners collaborated in the program.

Design: Prospective CV risk assessment, educational interventions, and follow-up.