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Development of Bioequivalent Extended Release Tablets of
Development of Bioequivalent Extended Release Tablets of

Oral Extended Release Drug Delivery System: A Promising Approach
Oral Extended Release Drug Delivery System: A Promising Approach

... Therapeutic range of the drug must be high. A drug for ER drug delivery system because more lipid soluble drug ERDDS should have therapeutic range wide enough such will not partition out of the lipid membrane once it gets in that variations in the release do not result in concentration the membrane. ...
Drugs and nutrition Drug disposition in obesity and protein–energy
Drugs and nutrition Drug disposition in obesity and protein–energy

... Malnutrition and body weight PCM and obesity occur as a result of nutrient and metabolic needs being inadequately met over time; reflecting chronic deficits or imbalances in macronutrients, but both including micronutrient deficits as well(12,13). PCM results in growth failure in children and uninte ...
Idera Pharmaceuticals Expands Pipeline by Initiating Clinical
Idera Pharmaceuticals Expands Pipeline by Initiating Clinical

... In two presentations at the OTS meeting, Idera scientists summarized the results of several preclinical studies of IMO-9200. Collectively, the data showed that IMO-9200 dose-dependently inhibited the induction of multiple inflammatory cytokines, including IL-12, IP-10, IFN-α, IL-6, IL-1β and MCP-1, ...
14 Medicines management Janet Krska and Brian Godman Sample chapter copyright Pharmaceutical Press
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... practitioner and patient decisions about appropriate healthcare for specific clinical circumstances’.15 Guidelines may not indicate which specific drug or product to use in any given circumstance, often recommending a therapeutic class. Smaller local groups such as DTCs may develop their own guideli ...
UoB-CLN-QCD-002-DSUR-template-v-1-0-for-circulation-doc
UoB-CLN-QCD-002-DSUR-template-v-1-0-for-circulation-doc

... Only capture the IMP(s) within the trial (as stated in the CTA application, including placebos), i.e. do not include any non-IMPs used in the trial ...
Drug
Drug

... The drug can have local effects - Epinephrine for asthma. The drug can have systemic effects - general anesthetics Large surface area, limited thickness of pulmonary membrane and high blood flow allow for almost instant absorption by diffusion Avoid first pass effect Disadvantages: Administration is ...
This PDF is a selection from a published volume
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... patients. RP for pharmaceuticals is not simply analogous to a defined contribution approach to subsidizing insurance coverage. Although a major purpose of RI' is to stimulate competition, theory suggests that the achievement of this goal is im]ikely, and this is confirmed by the empirical evidence. ...
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4.2 Posology and method of administration

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CHB_Prescribe_012_ EPR clinical checking and supply requests

Pravin R - Pivot Pharmaceuticals
Pravin R - Pivot Pharmaceuticals

... Build and enhance the pipeline value of the company through development of early-stage preclinical assets of the company across GI, diabetes and cancer areas Integrated all the scientific and operational activities of the company across multiple sites in the United States and in India Led the Joint ...
contaminantion in herbal drug and preparations
contaminantion in herbal drug and preparations

... integrate phytotherapy into their doctrines even though they are based on different cultural models. Pharmacist and physicians should be more aware about safety of herbal preparation as use of these preparations is increasing by patients day by day. Chemical compounds of herbal drugs could also be h ...
Antibiotic Use in Animal Production
Antibiotic Use in Animal Production

Fair Balance (FB)
Fair Balance (FB)

... • Instructions which are covered by standards of practice for all drugs – e.g. instruct patients to keep out of reach of children – e.g. only physicians who are knowledgeable with the product or class should prescribe ...
Quantitative Prediction of Transporter- and Enzyme
Quantitative Prediction of Transporter- and Enzyme

... many clinically important anionic drugs, including 3-hydroxy3-methylglutaryl coenzyme A reductase inhibitors (statins) (Shitara and Sugiyama, 2006; Kalliokoski and Niemi, 2009; All authors are full-time employees of Pfizer. The authors have no conflicts of interest that are directly relevant to this ...
IRTRA® Combination Tablets LD/HD
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... Irbesartan is a long-acting ARB originally created by Sanofi (Headquarters: France) with a long half-life in blood and a 24-hour-lasting blood pressure-lowering effect, having high anti-hypertensive effect in mild to severe hypertension. Based on the large-scale clinical trials, IDNT and IRMA2, whic ...
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... but examined the spleen, lungs, liver and kidney organ systems. A more recent series of animal studies in which I participated did not find any adverse effects over 16 days of treatment with pokeweed mitogen, neither behavioral nor on gross necropsy (Lazarus et a/., Me~abo/km, in press). This group ...
APPLICATIONS OF METABOLOMICS
APPLICATIONS OF METABOLOMICS

... genotype-envirotype relationships. Metabolomics is increasingly being used in a variety of health applications including pharmacology, pre-clinical drug trials, toxicology, transplant monitoring, newborn screening and clinical chemistry. However, a key limitation to metabolomics is the fact that the ...
Bevacizumab vs Ranibizumab Treatment for Age
Bevacizumab vs Ranibizumab Treatment for Age

PDF - Santen Inc.
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Emcure Pharmaceuticals Limited 3/3/16
Emcure Pharmaceuticals Limited 3/3/16

... the falsification of some of your reported EM data may have affected the quality of your products. We acknowledge your (b)(4) after the inspection, your management changes, and your engagement with consultants. However, your investigation was not extended to all systems and areas that may have been ...
Major R&D Pipeline
Major R&D Pipeline

... ・Regarding the anticancer agent MORAb-003, after considering further development strategy for the indication of platinum-sensitive ovarian cancer, a new Phase II study was initiated in Japan, Europe and the United States. ・Regarding the development of the higher dose (23 mg) formulation for anti-Alz ...
AP-ZP - Edison Investment Research
AP-ZP - Edison Investment Research

... The development risks of Intec are largely centred on whether the AP technology can provide a definitive benefit over other controlled release (CR) formulations. The company has MRI evidence that APs are effectively retained in the stomach, but the question remains how this translates into a benefit ...
QUANTITATIVE ANALYSIS OF DOSE
QUANTITATIVE ANALYSIS OF DOSE

Product Information: Belimumab
Product Information: Belimumab

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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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