A Focus on Clinical Trials
... As evidenced by discussion of the endpoint/instrument in at least one of the following: • a TMA within the therapeutic area (not required to be the sponsor’s TMA) • consensus guidelines • an authoritative medical text • multiple peer-reviewed trials including at least one competitor’s trial. ...
... As evidenced by discussion of the endpoint/instrument in at least one of the following: • a TMA within the therapeutic area (not required to be the sponsor’s TMA) • consensus guidelines • an authoritative medical text • multiple peer-reviewed trials including at least one competitor’s trial. ...
Word version of Full Report
... There is a need for frequent laboratory monitoring of dose–effect12 via a blood test referred to as the International Normalised Ratio (INR). Maintaining an INR in the target range of 2.0 to 3.0 has been shown to reduce the risk of stroke by about two-thirds in patients with AF.9 Point-of-care testi ...
... There is a need for frequent laboratory monitoring of dose–effect12 via a blood test referred to as the International Normalised Ratio (INR). Maintaining an INR in the target range of 2.0 to 3.0 has been shown to reduce the risk of stroke by about two-thirds in patients with AF.9 Point-of-care testi ...
HIGHLIGHTS OF PRESCRIBING INFORMATION
... In five randomized, double-blind clinical trials of 1,319 subjects, 397 used DUAC Gel, 396 used benzoyl peroxide, 349 used clindamycin, and 177 used vehicle. Subjects were instructed to wash the face, wait 10 to 20 minutes, and then apply medication to the entire face, once daily in the evening befo ...
... In five randomized, double-blind clinical trials of 1,319 subjects, 397 used DUAC Gel, 396 used benzoyl peroxide, 349 used clindamycin, and 177 used vehicle. Subjects were instructed to wash the face, wait 10 to 20 minutes, and then apply medication to the entire face, once daily in the evening befo ...
Chapter 07: Anticholinergic (Parasympatholytic) Bronchodilators
... ammonium derivative of atropine that, similar to ipratropium, does not distribute well across lipid membranes in the body. It is usually administered parenterally as an antimuscarinic agent during reversal of neuromuscular blockade, as an alternative to atropine, with fewer ocular or central nervous ...
... ammonium derivative of atropine that, similar to ipratropium, does not distribute well across lipid membranes in the body. It is usually administered parenterally as an antimuscarinic agent during reversal of neuromuscular blockade, as an alternative to atropine, with fewer ocular or central nervous ...
Serotonin 2A Receptors Differentially Contribute to Abuse
... maintained by the unit dose of cocaine that engendered the highest response rates (0.03 mg/kg/infusion). Each round of reinstatement testing consisted of extinguishing the behavior, a reinstatement test day, and subsequently re-establishing stable cocaine self-administration. Behavior was extinguish ...
... maintained by the unit dose of cocaine that engendered the highest response rates (0.03 mg/kg/infusion). Each round of reinstatement testing consisted of extinguishing the behavior, a reinstatement test day, and subsequently re-establishing stable cocaine self-administration. Behavior was extinguish ...
1 Name: Thyroglobulin (Proloid) Class: Thyroid Hormone Mech.: T3
... Utility: Treat hypocalcemia. Reduces/prevents bone loss in older women (800 mg/d). Special Features: 27% calcium. Probably obsolete due to greater irritation (enteral or parenteral admin.) than other calcium preparations. ...
... Utility: Treat hypocalcemia. Reduces/prevents bone loss in older women (800 mg/d). Special Features: 27% calcium. Probably obsolete due to greater irritation (enteral or parenteral admin.) than other calcium preparations. ...
PDF - Journal of Applied Pharmaceutical Science
... receptors blockade was suggested for the extract effect since these receptors are responsible for bronchial and tracheal smooth muscle contraction and this is evident from the functional affinities of a variety of selective antagonists in airway tissues from diverse species, including humans (van Ni ...
... receptors blockade was suggested for the extract effect since these receptors are responsible for bronchial and tracheal smooth muscle contraction and this is evident from the functional affinities of a variety of selective antagonists in airway tissues from diverse species, including humans (van Ni ...
Phenolphthalein Report on Carcinogens, Thirteenth Edition CAS No. 77-09-8
... population has been exposed to phenolphthalein through its common use as an over-the-counter drug, particularly as a laxative. The typical oral dose of phenolphthalein as an over-the-counter laxative was 30 to 200 mg for adults and children aged 12 years or older; the recommended dose was not to ex ...
... population has been exposed to phenolphthalein through its common use as an over-the-counter drug, particularly as a laxative. The typical oral dose of phenolphthalein as an over-the-counter laxative was 30 to 200 mg for adults and children aged 12 years or older; the recommended dose was not to ex ...
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of
... Fig. 1. Study design and data collection schedule. Asterisks = patient-reported AEs, vital signs, clinical laboratory evaluations, and pharmacokinetics; black arrows = FPG; white arrows = HbA1c, body weight, and antibodies to exenatide (excluding at screening); black triangles = electrocardiograms ( ...
... Fig. 1. Study design and data collection schedule. Asterisks = patient-reported AEs, vital signs, clinical laboratory evaluations, and pharmacokinetics; black arrows = FPG; white arrows = HbA1c, body weight, and antibodies to exenatide (excluding at screening); black triangles = electrocardiograms ( ...
NEUROLEPTIC MALIGNANT SYNDROME – CURRENT
... condition and difficult to diagnose due to its well-known mimicry. All these features didn't allow the conduct of double-blind or placebo-controlled clinical trials in order to identify the most appropriate treatment. As a result, current practice is based on case-studies and no treatment protocol e ...
... condition and difficult to diagnose due to its well-known mimicry. All these features didn't allow the conduct of double-blind or placebo-controlled clinical trials in order to identify the most appropriate treatment. As a result, current practice is based on case-studies and no treatment protocol e ...
GHB: An Important Pharmacologic and Clinical Update
... In addition, myoclonic jerking was abolished with ethosuximide, decreased with diazepam, and increased with clonazepam.58 Anticonvulsants experimentally decreased the frequency of myoclonic jerking when administered prior to GHB.58 Stupor was decreased with ethosuximide.58 Valproate and ethosuximide ...
... In addition, myoclonic jerking was abolished with ethosuximide, decreased with diazepam, and increased with clonazepam.58 Anticonvulsants experimentally decreased the frequency of myoclonic jerking when administered prior to GHB.58 Stupor was decreased with ethosuximide.58 Valproate and ethosuximide ...
- Journal of Allergy and Clinical Immunology
... cannot be classified because of our lack of mechanistic information. Theoretically, any drug can induce an immune response. However, some drugs are more likely to elicit clinically relevant immune responses than are others. Drugs in this category include antimicrobial drugs, anticonvulsants, chemoth ...
... cannot be classified because of our lack of mechanistic information. Theoretically, any drug can induce an immune response. However, some drugs are more likely to elicit clinically relevant immune responses than are others. Drugs in this category include antimicrobial drugs, anticonvulsants, chemoth ...
ROCKET-AF: Rivaroxaban vs Warfarin in patients with Atrial
... DESIGN: randomized, multi‐centre 45 countries, double‐blinded, double‐dummy controlled trial with concealed allocation; non‐inferiority with pre‐ designed superiority, intention‐to‐treat & per‐protocol analysis. Funded by Johnson & Johnson and Bayer. INTERVENTION: rivaroxaban 20mg* po daily vs dos ...
... DESIGN: randomized, multi‐centre 45 countries, double‐blinded, double‐dummy controlled trial with concealed allocation; non‐inferiority with pre‐ designed superiority, intention‐to‐treat & per‐protocol analysis. Funded by Johnson & Johnson and Bayer. INTERVENTION: rivaroxaban 20mg* po daily vs dos ...
1 This is the pre-review version of the paper published in Journal of
... acidifying effect of the H2C=CH- substituent for all vinyl chain lengths studied to less than 40% of that observed in unconstrained systems. Due to the larger delocalization of charge in phenoxide anion vs. acetaldehyde enolate, inclusion of solvation contributions stabilizes the latter much more th ...
... acidifying effect of the H2C=CH- substituent for all vinyl chain lengths studied to less than 40% of that observed in unconstrained systems. Due to the larger delocalization of charge in phenoxide anion vs. acetaldehyde enolate, inclusion of solvation contributions stabilizes the latter much more th ...
Suitable for consideration of dabigatran?
... – dabigatran 110mg statistically significantly lower than warfarin – numerically but not statistically significantly lower for 150mg ...
... – dabigatran 110mg statistically significantly lower than warfarin – numerically but not statistically significantly lower for 150mg ...
Martindale: The Complete Drug Reference
... form of powder, capsules containing powder or enteric-coated granules (which may be opened before use and the contents sprinkled on soft food), enteric-coated tablets, or granules. If pancreatic enzymes are mixed with liquids or food the resulting mixture should not be allowed to stand for more than ...
... form of powder, capsules containing powder or enteric-coated granules (which may be opened before use and the contents sprinkled on soft food), enteric-coated tablets, or granules. If pancreatic enzymes are mixed with liquids or food the resulting mixture should not be allowed to stand for more than ...
Toward Understanding the Biology of a Complex Phenotype: Rat
... Behavioral testing continued 4 d after the matching session for pups and 2– 4 d after the matching session for adults. Eighteen-day-old rat pups were brought to the laboratory in their home cages with their mothers to minimize stress before and after testing. Adult rats were brought to the laborator ...
... Behavioral testing continued 4 d after the matching session for pups and 2– 4 d after the matching session for adults. Eighteen-day-old rat pups were brought to the laboratory in their home cages with their mothers to minimize stress before and after testing. Adult rats were brought to the laborator ...
Review of Remediation Standards for
... The problem presented by the adoption of an analytical instrument-based standard is that there is an implicit presumption that no measurable exposure is safe, such that exposures must, with increasing analytical precision, approach zero. This is illustrated by the ultra-low values used by the states ...
... The problem presented by the adoption of an analytical instrument-based standard is that there is an implicit presumption that no measurable exposure is safe, such that exposures must, with increasing analytical precision, approach zero. This is illustrated by the ultra-low values used by the states ...
German S3-guidelines on the treatment of psoriasis vulgaris (short
... various individual therapies. In addition to the 6,224 publications yielded by the literature search in the first version of the guidelines, we identified 1,443 new studies. Of these, 155 studies fulfilled the criteria for inclusion in the current guidelines and were included in the evaluations of t ...
... various individual therapies. In addition to the 6,224 publications yielded by the literature search in the first version of the guidelines, we identified 1,443 new studies. Of these, 155 studies fulfilled the criteria for inclusion in the current guidelines and were included in the evaluations of t ...
2nd Quarter Conference Call
... Eligen® B12 – Summary All research indicates that Eligen® B12 presents a significant improvement to help approach the problem of B12 supplementation, regardless of level of supplementation that may be required Emisphere is committed to commercializing Eligen® B12 as an opportunity for all defin ...
... Eligen® B12 – Summary All research indicates that Eligen® B12 presents a significant improvement to help approach the problem of B12 supplementation, regardless of level of supplementation that may be required Emisphere is committed to commercializing Eligen® B12 as an opportunity for all defin ...
Drug Treatments for Polycystic Ovary Syndrome
... the U.S. Food and Drug Administration (FDA) for this use. One study found that women taking desogestrel/ ethinyl estradiol (Apri) had lower hirsutism scores on a standardized scale (i.e., the Ferriman-Gallwey hirsutism score).34 Finasteride (Propecia) and flutamide (formerly Eulexin) are effective, ...
... the U.S. Food and Drug Administration (FDA) for this use. One study found that women taking desogestrel/ ethinyl estradiol (Apri) had lower hirsutism scores on a standardized scale (i.e., the Ferriman-Gallwey hirsutism score).34 Finasteride (Propecia) and flutamide (formerly Eulexin) are effective, ...
a I JN
... hypersensitivity or intolerance (23, 24). Clinical trials have demonstrated improved efficacy of febuxostat over allopurinol in patients with impaired renal function (23, 24). In a recent clinical trial, febuxostat 40 or 80 mg/day was more effective than allopurinol 300 mg/day in achieving a serum u ...
... hypersensitivity or intolerance (23, 24). Clinical trials have demonstrated improved efficacy of febuxostat over allopurinol in patients with impaired renal function (23, 24). In a recent clinical trial, febuxostat 40 or 80 mg/day was more effective than allopurinol 300 mg/day in achieving a serum u ...
Special Report: Companion BRAF Mutation Testing to Select Patients with
... the cobas 4800 BRAF V600 Mutation Test and more sensitive sequencing methods, but insufficient information was available to allow recalculation of the Phase III sample data. Comparison with sequencing showed that in addition to very high percent agreement for the V600E mutation, the companion test a ...
... the cobas 4800 BRAF V600 Mutation Test and more sensitive sequencing methods, but insufficient information was available to allow recalculation of the Phase III sample data. Comparison with sequencing showed that in addition to very high percent agreement for the V600E mutation, the companion test a ...
Mark Jansen, M.D.
... Oral Antibiotics Inhibit growth of P. acnes in pilosebaceous unit Tetracycline class have anti-inflammatory properties too Systemic antibiotics tend more rapid clinical improvement than topicals but carry risk of more side effects (candidiasis, GI distress, significant allergic or toxic reaction) ...
... Oral Antibiotics Inhibit growth of P. acnes in pilosebaceous unit Tetracycline class have anti-inflammatory properties too Systemic antibiotics tend more rapid clinical improvement than topicals but carry risk of more side effects (candidiasis, GI distress, significant allergic or toxic reaction) ...
How close are you to your blood pressure and
... besylate) tablets and Lipitor® (atorvastatin calcium) tablets—in a single pill to significantly lower, in conjunction with therapeutic lifestyle changes, both high blood pressure and high cholesterol. SELECTED SAFETY INFORMATION (CONTINUED) If you take CADUET, tell your doctor if you feel any new mu ...
... besylate) tablets and Lipitor® (atorvastatin calcium) tablets—in a single pill to significantly lower, in conjunction with therapeutic lifestyle changes, both high blood pressure and high cholesterol. SELECTED SAFETY INFORMATION (CONTINUED) If you take CADUET, tell your doctor if you feel any new mu ...
Bilastine
Bilastine (trade name Bilaxten) is a second generation antihistamine drug for the treatment of allergic rhinoconjunctivitis and urticaria (hives).It exerts its effect as a selective histamine H1 receptor antagonist, and has a effectiveness similar to cetirizine, fexofenadine and desloratadine. It was developed in Spain by FAES Farma.Bilastine is approved in the European Union for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria, but it is not approved by the U.S. Food and Drug Administration for any use in the United States. Bilastine meets the current European Academy of Allergy and Clinical Immunology (EAACI) and Allergic Rhinitis and its Impact of Asthma (ARIA) criteria for medication used in the treatment of allergic rhinitis.Bilastine has been effective in the treatment of ocular symptoms and diseases of allergies, including rhinoconjuctivitis. Additionally, bilastine has been shown to improve quality of life, and all nasal and ocular symptoms related to allergic rhinitis.