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Future Development Plan - sun pharma advanced research company
Future Development Plan - sun pharma advanced research company

... cancers. Somatostatin has a short half life and needs 3-4 injections daily SPARC has developed Octreotide depot 1M Inj. capable of maintaining therapeutic plasma levels for one month following a single injection. ...
Another Mix-up between Choral Hydrate and
Another Mix-up between Choral Hydrate and

... The chronology of the events in this case is of interest because it illustrates deficiencies in the medication system across the continuum of care, beginning with a “picking error” at the drug distribution warehouse, which was not detected when the medication was received at the community pharmacy. T ...
Inspire Complaint
Inspire Complaint

Glycopyrronium (as bromide) - Therapeutic Goods Administration
Glycopyrronium (as bromide) - Therapeutic Goods Administration

... Information was approved at the time this AusPAR was published. latter study, the improvement vs. placebo for the open-label tiotropium 18 microgram oncedaily arm was 0.083 L (p < 0.001). In both studies SEEBRI BREEZHALER demonstrated a rapid onset of bronchodilator effect. In the 6-month study the ...
BioRay Kids Line Guide
BioRay Kids Line Guide

... other toxins in their home, school, and lawn, on playgrounds, and public parks. These substances enter their small bodies through the skin, lungs, mouth, and eyes. ...
Presentation for Investors
Presentation for Investors

... the innovation solution for bad breath • ‘Like’ novel platform technology focus on removing the causes of Halitosis and other conditions of the mouth /tongue • 'Like' comes in a form of combined lollipop/breath mint/tongue scraper with microcapsules of Zinc • Zinc is known as an active ingredient th ...
Revised: December 2014 AN: 01089/2014 SUMMARY OF
Revised: December 2014 AN: 01089/2014 SUMMARY OF

Dabigatran
Dabigatran

... • Each drug has its own effect in lab tests. • The metabolic mechanisms of each drug differ; see drug interactions. • Each drug has to be managed individually. ...
review - International Research Journal of Pharmacy
review - International Research Journal of Pharmacy

... removal of the probe mechanically breaks it. The force required to pull the probe away from the adhesive at fixed rate is recorded as tack and it is expressed in grams.17 In vitro drug release studies The paddle over disc method (USP apparatus V) can be employed for assessment of the release of the ...
Field Guide to Herbal Dietary Supplements
Field Guide to Herbal Dietary Supplements

MANAGEMENT SCIENCE
MANAGEMENT SCIENCE

... their beliefs about products. Thus, in our model, substitution between products may occur when a new online review is published. Figure 1 shows a simplistic example of how a review may influence consumer’s beliefs about a given product feature, in this case image quality. The consumer has an initial ...
Product Monograph Template - Standard
Product Monograph Template - Standard

... Geriatrics (> 65 years of age): Of the total number of subjects in clinical studies of ULORIC®, 16% were 65 and over, while 4% were 75 and over. Comparing subjects in different age groups, no clinically significant differences in safety or efficacy were observed but greater sensitivity of some older ...
racemic drugs
racemic drugs

Richard E. Besser, MD Acting Director Centers for Disease Control and Prevention
Richard E. Besser, MD Acting Director Centers for Disease Control and Prevention

... change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and trea ...
the concepts of efficacy and safety
the concepts of efficacy and safety

... completely efficacious. In the beginning of this chapter, a safe technology was described intuitively as one that “causes no undue harm. ” Despite the apparent simplicity of that informal definition, it reflects a critical property of the concept of safety: that safety represents a value judgment of ...
Common Drug Interactions Leading to Adverse Drug
Common Drug Interactions Leading to Adverse Drug

Comprehensive Translational Assessment of Human Induced
Comprehensive Translational Assessment of Human Induced

... multichannel effects, where the deleterious effect of hERG potassium channel block may be balanced out by the drug effect on inward currents, as is the case for several marketed drugs (e.g., verapamil also blocks L-type calcium current, ranolazine blocks late sodium current) (Johannesen et al. 2014) ...
Formulation Tactics for the Delivery of Poorly Soluble Drugs
Formulation Tactics for the Delivery of Poorly Soluble Drugs

General Principles of Psychopharmacology
General Principles of Psychopharmacology

Adverse Drug Reactions to Antibiotics and Major Antibiotic Drug
Adverse Drug Reactions to Antibiotics and Major Antibiotic Drug

PRODUCT MONOGRAPH ARGATROBAN (argatroban for injection
PRODUCT MONOGRAPH ARGATROBAN (argatroban for injection

an extension of biopharmaceutics classification system
an extension of biopharmaceutics classification system

... The term biowaiver is applied to a regulatory drug approval process when the dossier (application) is approved based on evidence of equivalence other than through in vivo equivalence testing. Biowaiver means to obtain waive off for carrying out expensive and time-consuming BA and BE studies. BCS pro ...
formulation development and evaluation of sustained release
formulation development and evaluation of sustained release

... In recent years, the number of commercially available antiepileptic drugs (AEDs) has increased steadily. Although this may complicate management choices, it also offers welcome new options to individualize treatment more effectively. Because each of the available AEDs differs from others in many cli ...
Pharmacologic Treatment Options for Obesity: What Is Old Is New Again
Pharmacologic Treatment Options for Obesity: What Is Old Is New Again

... finally released on the market in 2012 after more than a decade without new drugs, and a third drug combination, naltrexone/bupropion, is undertaking a premarketing trial to assure cardiovascular safety. There is even a new formulation available for the old compound, phentermine, which was released ...
0316065.01 - Society of Nuclear Medicine
0316065.01 - Society of Nuclear Medicine

... Method for Radiopharmaceuticals CMS is struggling to determine payment for one new radiopharmaceutical drug. We acknowledge that payment for radiopharmaceuticals presents unique challenges since they have all the features of drugs, plus additional clinical and technological attributes which can make ...
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Biosimilar

A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is a copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original ""innovator"" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product.Drug related authorities such as European Medicines Agency (EMA), Food and Drug Administration (FDA), and Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies that demonstrate that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; animal studies (including the assessment of toxicity); and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.In case of a monoclonal antibody-containing medicinal product, such as Remsima, extensive physicochemical and biological characterization for it and its reference product Remicade was conducted in order to demonstrate their highly similar properties. Consequently, EMA have granted a marketing authorisation for only a few numbers of biosimilars since 2006 including a monoclonal antibody which is recently approved. Meanwhile, on March 6, 2015, the FDA approved the United States's first biosimilar product, the biosimilar filgrastim Zarxio.
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