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International Journal of Phytopharmacology
International Journal of Phytopharmacology

... been developed into a wide range of formulations from conventional dosage forms for immediate release of the drug to controlled release dosage forms for the constant rate of drug release. Oral rouse is the most convenient and commonly used method of drug delivery. More than 50% of drug delivery syst ...
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Chapter 1 - Introduction to Psychopharmacology MULTIPLE

... b. Henrician Articles c. Nuremberg Principles d. European Convention on Human Rights Act ...
Guidelines Revised for Management of Type 2 Diabetes Mellitus
Guidelines Revised for Management of Type 2 Diabetes Mellitus

... therefore recommend greater caution in using the thiazolidinediones, especially in patients at risk of, or with, CHF [congestive heart failure]." Approximately 1 year ago, the American Diabetes Association and the European Association for the Study of Diabetes commissioned development of an evidence ...
Annual Report 2011 of the Danish Medicines Agency´s laboratory
Annual Report 2011 of the Danish Medicines Agency´s laboratory

... Since 2008 the Danish Medicines Agency has worked with the framework of a general risk management model, based on experience from the three pilot projects. The implementation of a general risk management model will improve the prioritization and coordination in the control activities at the Danish M ...
Protein and Peptides Drug delivery, PEGylations and Biotech based products, Immunomodulated molecules
Protein and Peptides Drug delivery, PEGylations and Biotech based products, Immunomodulated molecules

...  ‘Polymer therapeutics’ is an umbrella term used to describe Macromolecular drugs, Polymer-drug and Polymer-protein conjugates, Polymeric micelles containing covalently bound drug, and Polyplexes DNA delivery.  All the subclasses use specific water soluble polymers, either as the bioactive itself ...
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CATB 1Q16 earnings 12may2016

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MS_Word ~ 357 KB - CIAP

CurcumaSorb Mind - Pure Encapsulations
CurcumaSorb Mind - Pure Encapsulations

Clinical Pharmacokinetic Studies of Pharmaceuticals
Clinical Pharmacokinetic Studies of Pharmaceuticals

... and conduct of subsequent clinical trials. They are also necessary for appropriate analysis and evaluation of the efficacy and safety data obtained in clinical trials for new drug development and in post-marketing clinical trials. The results of non-clinical pharmacological and toxicological studies ...
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Chapter 10 Pharmacology

... was once an extract of willow bark. Insulin was the first drug to be produced from genetically altered bacteria (recombinant) ...
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III. challenges in drug delivery

... Whereas traditional biology often focused on only one particular component of a system, systems biology aims to study how they all work together [3]. It is this dynamic understanding that is necessary to design effective drug delivery strategies. The immediate appeal of such an approach from a drug ...
FDA and the Challenge of Alternative Medicine: Realistic
FDA and the Challenge of Alternative Medicine: Realistic

... truth’. In the meantime, supplements must be sold without disclosing what is already known about their effects... Millions of [Americans] are willing to spend their own resources on protecting their heath through diet, exercise and supplements. They are not charging their herbs and vitamins to insur ...
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Mechanism of Action

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Suggestion from clinicians

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Current Management of Basal Cell Carcinoma, Part 3

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... v Oncology setting: combination of a biologic with SOC small molecule therapy is well known v RA: combination of etanercept, infliximab, adalimumab with MTX etc. v During clinical development phase: precise measurement of both molecules and an understanding of assays used to measure them is neces ...
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Glossary of Clinical Trial Terms

... approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Potential treatments, however, must first be studied in laboratory models or animals to determine its safety before they can be tried in peop ...
In Vitro-In Vivo Correlation (IVIVC) and Determining
In Vitro-In Vivo Correlation (IVIVC) and Determining

Print - Philosophical Transactions of the Royal Society B
Print - Philosophical Transactions of the Royal Society B

... benefits deepens and demands for natural products increase, previously serendipitous discoveries evolve into active searches for new medicines. Many drugs presently prescribed by physicians are either directly isolated from plants or are artificially modified versions of natural products. Scientists ...
Drug Metabolism and Reaction
Drug Metabolism and Reaction

...  Rats: often very rapid metabolizers; CYP2C is the major family in the liver with significant gender differences  Cynomolgus monkeys: reported to have low CYP1A2 activity ...
Ethnic and cultural factors in psychopharmacology
Ethnic and cultural factors in psychopharmacology

< 1 ... 66 67 68 69 70 71 72 73 74 ... 193 >

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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