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PubMed1996

Prevention of varicella: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention.

These recommendations represent the first statement by the Advisory Committee on Immunization Practices (ACIP) on the use of live, attenuated varicella virus vaccine--VARIVAX--manufactured by Merck and Company, Inc. and licensed in March 1995 for use in healthy persons > or = 12 months of age. In addition to presenting information regarding vaccine, this statement updates previous recommendations concerning the use of varicella zoster immune globulin (VZIG) as prophylaxis against varicella (MMWR 1984; 33:84-90, 95-100).

Acyclovir↗
PubMedDate not supplied

[Proscar (finasteride, MSD) in the treatment of patients with prostatic hyperplasia].

The drug proskar (finasteride) belongs to 5 alpha-reductase blockers breaking the steps of prostatic adenoma pathogenesis. Proskar (Merck and Co. Inc., USA) was given to 38 patients with prostatic adenoma stage I and II (residual urine < 50 ml) admitted to urological clinic of the Moscow Medical Academy in 1993-1995. Daily dose was 5 mg. In patients with associated inflammation it was treated prior to proskar administration. To reject carcinoma, patients with elevated levels of prostatic specific antigen (< 4 ng/ml) were subjected to polyfocal biopsy of the gland. In any case, these patients received antiandrogens flutamide or androkur. Subjective response was achieved in 33 of 38 patients (86.8%). Better urination was reported in 29 patients (76.3%). Abdominal and transrectal ultrasonic scanning registered a decrease in the size of the prostate in 25 (65.8%) patients. Proskar was well tolerated, sexual disturbances occurred only in 2 patients. Proskar is effective in therapy of prostatic adenoma stage I. However, its intake must be long and regular, otherwise recurrent clinical symptoms and further growth of prostatic adenoma are possible.

5-alpha Reductase Inhibitors↗
PubMed1997

Safety and immunogenicity of a conjugated Haemophilus influenzae type B polysaccharide-Neisseria meningitidis outer membrane protein vaccine.

This study was performed to determine the immunogenicity and safety of a conjugate Haemophilus influenzae type b (Hib) vaccine (PedvaxHIB:Merck Sharp & Dohme Inc, West Point, PA, USA) in Taiwanese children. There were two groups in this study. Group A included 56 infants at 2 months of age, who received an initial dose of Hib conjugate vaccine at age 2 months and 4 months. Another booster dose was given between 12 and 15 months of age. Group B included 58 children, aged 11 to 14 months, who were vaccinated at the time of enrollment and 2 months after the first vaccination. The results showed that this Hib conjugate vaccine was highly immunogenic with 100% and 86% of vaccinees in group A developing anti-Hib polyribosylribitol phosphate (PRP) antibody titers above 0.15 microgram/mL and 1 microgram/mL, respectively, after two vaccinations. A slightly better response rate was observed in group B, with 100% and 97% of vaccinees developing antibody titers above 0.15 microgram/mL and 1 microgram/ml, respectively, after two vaccinations. A significant booster effect was seen in group A; the proportion of subjects with antibody titers above 1 microgram/mL increased from 38% to 95%, and the geometric mean titer increased from 0.68 microgram/mL to 11.92 micrograms/mL. Adverse reactions were uncommon. Mild reactions consisted of low-grade fever and local discomfort. We conclude that the Hib conjugate vaccine is highly immunogenic and safe when given to Taiwanese children as young as 2 months of age.

Antibodies, Bacterial↗
PubMedDate not supplied

[Combined use of 5 alpha-reductase inhibitors and alpha-l adrenergic receptor blockers in patients with benign prostatic hyperplasia].

88 patients with benign prostatic hyperplasia (BPH) were given the inhibitor of 5 alpha-reductase proscar (finasteride, Merck and Co. Inc., USA) for 12-14 months and uroselective blocker of alpha-adrenoreceptors alfuzosin (dalfas, Synthelabo Group, France) for 4-5 months. The patients were examined before the combined treatment and on the treatment month 1, 3, 6 and 12. The proscar plus alfuzosin combination produced a response after 2-3-week treatment due to alpha-blocker Further, the effect was enhanced by the action of inhibitor of 5 alpha-reductase. Combination of alfuzosin with proscar meets three principal requirements demanded of BPH chemotherapy: improves urination, inhibits the growth of adenomatous tissue, diminishes the size of the enlarged prostate.

Adrenergic alpha-Antagonists↗
PubMed2004

Celecoxib but not rofecoxib inhibits the growth of transformed cells in vitro.

PURPOSE: Nonsteroidal anti-inflammatory drugs reduce the risk of colorectal cancer. The cyclooxygenase (COX) pathway of arachidonic acid metabolism is an important target for nonsteroidal anti-inflammatory drugs. Increased expression of COX-2 was recently shown to be an important step in the multistep process of colorectal cancer carcinogenesis. The new COX-2-specific inhibitors offer the benefit of cancer protection without the gastrointestinal toxicity reported for the old drugs. The purpose of this study was to compare the growth effects of two specific COX-2 inhibitors, celecoxib (Pfizer, Inc., New York, NY), and rofecoxib (Merck, White House Station, NJ) in normal and transformed enterocytes. EXPERIMENTAL DESIGN: Cultures of normal rat intestinal epithelial cell line, IEC-18, vector control cells, c-K-ras, c-K-ras-bak, and antisense-bak derivatives were treated with different dosages of celecoxib (0-60 micro M) and rofecoxib (0-20 micro M). Cell cycle analysis and apoptosis were assessed by fluorescence-activated cell sorting analysis. Protein expression was assessed by Western blot analysis and caspases 3 and 8 activities by ELISA. RESULTS: Celecoxib inhibited cell growth and induced apoptosis in a time- and dose-dependent manner. IEC18 parental cells were two to four times more resistant to celecoxib than ras, ras-bak, and antisense bak transformed cells that overexpress the COX-2 protein. The induction of apoptosis by celecoxib involved the caspase pathways. Rofecoxib, up to its maximal concentration of 20 micro M, did not inhibit cell growth or induce apoptosis. CONCLUSIONS: Celecoxib may prove to be a very efficient component in the prevention and treatment of gastrointestinal tumors because it inhibits the growth of cancerous cells without affecting the growth of normal cells.

Animals↗
PubMed2004

Technology evaluation: EMD-273063, EMD Lexigen.

EMD-273063 is an antibody/cytokine fusion protein comprised of a humanized version of the murine anti-GD2 antibody 14.18 coupled to two molecules of IL-2. It is being developed by EMD Lexigen Research Center Corp (a subsidiary of Merck KGaA) and its sister company, EMD Pharmaceuticals Inc, for the potential treatment of neuroblastoma and melanoma, for which it is in preclinical and phase I clinical trials, respectively.

Animals↗
PubMed2001

Kinetic Resolution of Amines by a Nonenzymatic Acylation Catalyst We thank Michael M.-C. Lo, Dr. J. Craig Ruble, and Beata Tao for helpful discussions and preliminary studies, and we also thank Dr. George P. Luke (ARIAD Pharmaceuticals, Inc.) for providing the primary amine illustrated in entry 8 of Table 1. Support has been provided by Bristol-Myers Squibb, Merck, the National Institutes of Health (National Institute of General Medical Sciences, R01-GM57034), Novartis, Pfizer, and Pharmacia.

Explore the source record for details and available documents.

Journal Article↗
PubMed2001

Kinetic Resolution of Amines by a Nonenzymatic Acylation Catalyst We thank Michael M.-C. Lo, Dr. J. Craig Ruble, and Beata Tao for helpful discussions and preliminary studies, and we also thank Dr. George P. Luke (ARIAD Pharmaceuticals, Inc.) for providing the primary amine illustrated in entry 8 of Table 1. Support has been provided by Bristol-Myers Squibb, Merck, the National Institutes of Health (National Institute of General Medical Sciences, R01-GM57034), Novartis, Pfizer, and Pharmacia.

Explore the source record for details and available documents.

Journal Article↗
PubMed2006

Mechanical characterisation of three percutaneous vertebroplasty biomaterials.

Percutanous vertebroplasty (PVP) is gaining popularity for the treatment of vertebral compression fractures. The need of obtaining low viscosity materials for injection through small bore needles and the necessity of visualising the fluid flow during injection have led users to the formulation of a number of ad-hoc recipes aimed at adapting PMMA cements for this use. Industry, on its part, has addressed these requirements by developing specific products for this application. This study aimed at providing a direct comparison of a wide range of mechanical properties between three commercially available biomaterials developed for PVP: two PMMA based materials, Osteopal V (Merck Biomaterial GMBH, Dermstedt, D) and Verterbroplastic (DePuy Acromed, Inc, MA, USA), and a Bis-GMA composite, Cortoss (Orthovita, PA, USA). Cortoss consistently exhibited higher values for compressive strength, bending modulus and shear strength to both Osteopal V and Vertebroplastic. The creep behaviour of Cortoss was also different from that of the two PMMA cements.PVP can take advantage from the development of new injectable biomaterials in response to the problems associated with the use of PMMA in a highly vascularised area such as the vertebral body. In addition careful modulation of the mechanical properties of the material has the potential to further improve the outcome of PVP, possibly reducing the risk of adjacent level fractures associated with the procedure.

Biocompatible Materials↗
PubMed1999

Validation of assays for use with combination vaccines.

A general methodology is presented for the validation of assays used for testing combination vaccines. The presentation is detailed and technical as our intention is to address challenges that we have encountered in the design and statistical analysis of assay validation studies. There are several noteworthy features which render the approach particularly useful in practice. It employs a statistical experimental design approach to the investigation of assay ruggedness with respect to manufacturing variability; it makes use of the assay variability results to determine the level of test-run replication necessary to achieve precision compatible with the product specifications; and, it provides a generic approach to assay validation. With combination vaccines, as with other pharmaceuticals, the analytical methods for release and stability must be validated early in the development programme Several things, though, distinguish this task with combination vaccines: (1) assays are typically pre-existing and often have been validated for use with an established sample matrix, e.g. a monovalent formulation; (2) sample matrices are complex and therefore more subject to manufacturing variability and more likely to cause assay interferences; and (3) the analytical workload is considerable due to the number of antigens. The methodology presented here was developed jointly by Merck Research Laboratories (West Point, PA) and Pasteur Mérieux Connaught, Inc. (Swiftwater, PA). Many of the issues discussed here have application outside of combination vaccines and are common features of all assay validations.

Biological Assay↗
PubMedDate not supplied

Comparison of gastric emptying times in healthy cats simultaneously evaluated with radiopaque markers and nuclear scintigraphy.

Gastric emptying in 18 healthy cats was assessed simultaneously using scintigraphy and barium-impregnated polyethylene spheres (BIPS). Canned Prescription Diet Feline c/d (Hill's Pet Nutrition, Inc., Topeka, KS) labeled with 99mTc-disofenin (Hepatolite, DuPont Merck Pharmaceutical Co., Billerica, Mass.) was fed on four separate days. Scintigraphic images were obtained at time 0 and then every 30 minutes to 6 hours. On the fourth scan day, 30 small (1.5 mm) and 10 large (5 mm) BIPS (Chemstock Animal Health Ltd., Christchurch, New Zealand) were mixed with the labeled meal, and in addition to scintigraphy, radiographs were made at 60-minute intervals for 6 hours. Gastric emptying was 11 to 15% slower on the day of simultaneous radiography as compared with the 3 days when only scintigraphy was performed (p < or = .05). Percentage retention of 1.5 mm BIPS in the stomach was significantly greater than the percentage retained gastric activity at hours 1, 2, 3, 4, 5, and 6 (p < or = .05). BIPS were clustered in the pyloric region of the stomach by 3 hours in all cats. In 10/18 animals, all BIPS were retained in pyloric region of the stomach at 6 hours, despite observable decreased size of the gastric silhouette and < or =15% retained gastric activity. In conclusion, gastric emptying of 1.5-mm BIPS does not parallel gastric emptying of 99mTc-disofenin labeled canned Prescription Diet Feline c/d. Stress associated with radiography may delay gastric emptying. Diet type should be considered when evaluating clinical radiographic studies where BIPS have been used.

Animals↗
PubMed2006

Effect of microclimate on bacterial count and airborne emission from dairy barns on the environment.

The main microclimate parameters, i.e. bacterial count and airborne emission to the immediate environment, were analyzed in a dairy barn. Air temperature, relative humidity and air flow velocity were measured on an attested Testo 400 device (Testo Inc., Germany). Air samples were collected by use of a Merck MAS-100 device (Merck KgaA, Darmstadt, Germany) onto a commercially available nutrient Columbia agar (Biolife, Milan, Italy) and incubated for 24 h in an incubator at 37 degrees C work temperature. Measurements were carried out once a week in the morning, at noon, and in the evening during October and November 2002. In the barn, measurements were performed in the animal housing area along the feedlot, and outside the barn at a distance of 5 m, 25 m and 50 m eastward and westward from the barn. The measured dairy barn temperature ranged from 11.2 degrees C to 13.1 degrees C, relative humidity from 71.3-78.6 %, and air flow velocity from 0.09-0.11 m/s. The mean value of total bacterial count in the barn air ranged from 2.82 x 10 (4) cfu/m(3) at noon to 7.76 x 10(4) cfu/m(3) in the evening. Bacterial count decreased at particular measuring sites outside the barn, with Wilcoxon matched pair test showing statistical significance (p < 0.05) at a distance of 5 m eastward and 5 m westward of the barn.

Agricultural Workers' Diseases↗
PubMed1991

Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older. Recommendations of the immunization practices advisory committee (ACIP).

These recommendations include information on use of two vaccines recently licensed for use with infants: Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate) (HbOC), manufactured by Praxis Biologics, Inc., and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PRP-OMP), manufactured by Merck Sharp and Dohme, newly licensed for use with infants. This statement also updates recommendations for use of these and other Haemophilus b conjugate vaccines with older children and adults.

Adult↗
PubMed2001

Evaluation of the effect of seven acrylic bone cements on erythrocytes and plasmatic phase of coagulation.

The haemolytic activity and the effect on the plasmatic phase of coagulation of seven bone cements were evaluated (Sulfix-60 from Sulzer Orthopedic Inc., a bone cement at low viscosity from Zimmer, a bone cement dough-type from Zimmer, Palacos R from Merck, CMW1, CMW2 and CMW3 from DePuy International Ltd.). Haemolytic activity was tested by adding the cement extracts in phosphate buffered saline to a suspension of erythrocytes. After 4 h incubation at 37 degrees C, the haemoglobin concentration was determined on the supernatants by colorimetric method. The effect on the plasmatic phase of coagulation was tested by adding the cement extracts in saline to human plasma. After 30 min incubation at room temperature activated partial thromboplastin time (APTT) was determined. All extracts induced non-significant variations of haemoglobin concentration and APTT. It was concluded that the tested cement extracts do not induce haemolysis and do not activate the intrinsic pathway of coagulation, at least in the tests that were performed.

Acrylates↗
PubMed2002

Platelet glycoprotein IIb/IIIa inhibitor use during percutaneous coronary intervention: IIb or Not IIb, what is the question?

Over the past decade, numerous placebo-controlled randomized clinical trials have documented robust clinical benefits of intravenous platelet glycoprotein (GP) IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention (PCI). This evidence has led to U.S. Food and Drug Administration approval and indication for use of two GP IIb/IIIa inhibitors at the time of PCI, namely, the chimeric monoclonal antibody fragment abciximab (ReoPro, Centocor, Inc. and Eli Lilly & Company) and the cyclic heptapeptide small molecule eptifibatide (Integrilin, COR Therapeutics and Key Pharmaceuticals). Currently, another small molecule GP IIb/IIIa inhibitor, tirofiban (Aggrastat, Merck & Company), which (similar to eptifibatide) is approved for the medical therapy of patients with non-ST segment elevation acute coronary syndromes (ACS), has not received indication for use in the PCI setting. Although the clinical benefits of both abciximab and eptifibatide administered at the time of PCI have been proven in randomized clinical trials, only abciximab has demonstrated a late survival advantage in patients following PCI. Evidence in support of the presence, magnitude and possible mechanisms for abciximab survival advantage is herein reviewed.

Abciximab↗
PubMedDate not supplied

Don't wait for the crisis. Finding the paradigm in the pattern. Interview by Joe Flower.

Joel Barker has been talking about the future for a long time past. His message: Change happens. Change happens as paradigms shift--the way we picture the universe shifts, and life is different. Relationships and values change their meaning. And because they mean something different, we change them. Barker's question is: How do you manage this change? How do you get ahead of it, and not lag behind it? How do you become its partner and not its victim? These are challenging questions, and hundreds of corporations have invited Barker to come ask them. His client list ranges over much of the Fortune 500--from IBM and DuPont to Honeywell, Boeing, and Gulf Oil--and it includes such healthcare clients as Merck, Upjohn, the Mayo clinics, and the Sisters of Charity. Barker has worked with these questions for the past 17 years, first as director of the pioneering Future Studies Department of the Science Museum of Minnesota, then as president of Infinity Limited, Inc. He has put his answers into a video, "Discovering the Future," and two books, the 1985 Discovering the Future: The Business of Paradigms, and the new Future Edge: The Paradigm Principles Guide for the '90s. We spent a recent morning talking with him about what a paradigm is, and what happens when a paradigm shifts.

Hospital Administration↗
PubMed2001

Selection of bioprocess simulation software for industrial applications.

Two commercially available, process-simulation software packages (Aspen Batch Plus v1.2, Aspen Technology, Inc., Cambridge, Massachusetts, and Intelligen SuperPro v3.0, INTELLIGEN, INC., Scotch Plains, Ner Jersey) are evaluated for use in modeling industrial, biotechnology processes. Software is quantitatively evaluated by Kepner-Tregoe Decision Analysis (Kepner and Tregoe, 1981). This evaluation shows that Aspen Batch Plus v1.2 (ABP) and Intelligen SuperPro v3.0 (ISP) can successfully perform specific simulation tasks but do not provide a complete model of all phenomena occurring within a biotechnology process. Software is best suited to provide a format for process management, using material and energy balances to answer scheduling questions, explore equipment change-outs, and calculate cost data. The ability of simulation software to accurately predict unit operation scale-up and optimize bioprocesses is limited. To realistically evaluate the software, a vaccine manufacturing process under development at Merck & Company is simulated. Case studies from the vaccine process are presented as examples of how ABP and ISP can be used to shed light on real-world processing issues.

Biotechnology↗