Pharmaceutical Product Development

About: Pharmaceutical Product Development is a company organization based out in Wilmington, North Carolina, United States. It is known for research contribution in the topics: Immunotoxin & Fusion protein. The organization has 402 authors who have published 353 publications receiving 16396 citations.

A randomized, multiple-dose parallel study to compare the pharmacokinetic parameters of synthetic conjugated estrogens, A, administered as oral tablet or vaginal cream.

Abstract: Objective:A randomized, parallel-design study was conducted to determine the pharmacokinetic profile of synthetic conjugated estrogens A (SCE-A) vaginal cream (0.625 mg SCE-A/g) when administered at intervals (1 g once daily for 7 d, then twice weekly) over a 27-day period as compared with t

Administering the Sarcoidosis Health Questionnaire to sarcoidosis patients in Serbia.

Abstract: Objective: The aim of this study was to use a Serbian-language version of the disease-specific, self-report Sarcoidosis Health Questionnaire (SHQ), which was designed and originally validated in the United States, to assess health status in sarcoidosis patients in Serbia, as well as validating the instrument for use in the country. Methods: This was a cross-sectional study of 346 patients with biopsy-confirmed sarcoidosis. To evaluate the health status of the patients, we used the SHQ, which was translated into Serbian for the purposes of this study. We compared SHQ scores by patient gender and age, as well as by disease duration and treatment. Lower SHQ scores indicate poorer health status. Results: The SHQ scores demonstrated differences in health status among subgroups of the sarcoidosis patients evaluated. Health status was found to be significantly poorer among female patients and older patients, as well as among those with chronic sarcoidosis or extrapulmonary manifestations of the disease. Monotherapy with methotrexate was found to be associated with better health status than was monotherapy with prednisone or combination therapy with prednisone and methotrexate. Conclusions: The SHQ is a reliable, disease-specific, self-report instrument. Although originally designed for use in the United States, the SHQ could be a useful tool for the assessment of health status in various non-English-speaking populations of sarcoidosis patients.

NatHER: protocol for systematic evaluation of trends in survival among patients with HER2-positive advanced breast cancer

Abstract: Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) is an aggressive form of breast cancer and is historically associated with poor outcomes compared with HER2-negative MBC. Since 1998, four drugs have been globally approved for the targeted treatment of HER2-positive MBC. Additional advances in patient care—such as improved breast cancer screening, HER2 testing, and supportive care—have also occurred. The objective of this systematic review and meta-analysis is to determine whether there has been a cumulative change in survival over time in patients with HER2-positive advanced breast cancer based on results from interventional clinical trials (ICTs) and observational studies and to compare outcomes across these types of studies. A systematic search of Medline, EMBASE, and the Cochrane Central Register of Controlled Trials will be performed. Two investigators will independently assess each abstract for inclusion. English language reports of ICTs and observational studies that include patients with HER2-positive advanced breast cancer from 1987 onwards will be considered. The primary outcome of interest is overall survival; secondary outcomes include progression-free survival and safety. Data on clinical outcomes, as well as on study design, study population, treatment/intervention, methodological quality, and outcomes, will be extracted using a structured codebook developed by the authors for this study. Standard and cumulative random effects meta-analysis will be performed to derive pooled risk estimates, both overall and by study design, controlling for covariates such as aggregate demographic and clinical characteristics of patients, treatment/intervention, and study characteristics. Heterogeneity of studies will be evaluated using the I2 statistic. Differences in risk estimates by quality characteristics will be performed using meta-regression. This study will evaluate current and evolving trends in survival associated with HER2-positive advanced breast cancer over nearly 30 years and will build upon prior, less comprehensive, systematic analyses. This information is important to patients, healthcare providers, and researchers, particularly in the advanced disease setting, in which new therapies have been recently approved. Including observational studies allows us to evaluate real-world effectiveness; useful information will be gained by comparing findings from observational studies with those from ICTs. PROSPERO CRD42014014345

Automation Practices in Large Molecule Bioanalysis: Recommendations from Group L5 of the Global Bioanalytical Consortium

Abstract: In recent years, the use of automated sample handling instrumentation has come to the forefront of bioanalytical analysis in order to ensure greater assay consistency and throughput Since robotic systems are becoming part of everyday analytical procedures, the need for consistent guidance across the pharmaceutical industry has become increasingly important Pre-existing regulations do not go into sufficient detail in regard to how to handle the use of robotic systems for use with analytical methods, especially large molecule bioanalysis As a result, Global Bioanalytical Consortium (GBC) Group L5 has put forth specific recommendations for the validation, qualification, and use of robotic systems as part of large molecule bioanalytical analyses in the present white paper The guidelines presented can be followed to ensure that there is a consistent, transparent methodology that will ensure that robotic systems can be effectively used and documented in a regulated bioanalytical laboratory setting This will allow for consistent use of robotic sample handling instrumentation as part of large molecule bioanalysis across the globe

Comparison of the Levels of Rubber Stopper-Related Organic Leachables in Commercially Available Vialed Liquid and Lyophilized Drug Products.

Abstract: Rubber stoppers that seal the primary packaging systems of parenteral pharmaceutical products have the potential to introduce impurities into the drug during storage. While this interaction has been well characterized for products stored as an aqueous liquid, it is not well understood how the interaction is affected when the product is stored as a lyophilized solid. Accordingly, the goal of this study was to determine how lyophilization affects the propensity for impurity migration (leaching) into the product. The concentration of substances in the stopper and the concentration of these substances that had leached into the product at equilibrium were measured and used to calculate equilibrium constants, which quantifies the degree of partitioning of each compound between each unique stopper and drug matrix, for twelve lyophilized and twelve liquid commercial drug products. Lyophilized products were shown to have a significantly increased propensity to contain substances that migrated from their stopper as compared to liquid products, as supported both by the general qualitative/quantitative leachable profile and the equilibrium constants obtained. The conversion of a liquid drug formulation to a lyophilized solid during storage will increase the number and concentration of impurities leached from the stopper.