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THE ESSENTIALS OF CHRONOPHARMACOTHERAPEUTICS  Review Article VIKRAM S. CHHABRA
THE ESSENTIALS OF CHRONOPHARMACOTHERAPEUTICS Review Article VIKRAM S. CHHABRA

... Recent advances in chronopharmacology and requirement of an appropriate technology to deliver the drug at specific time and site led to the development of novel type of drug delivery systems as chronotropic or Pulsatile drug delivery systems. Chronopharmacokinetics deals with the study of the tempor ...
Generic legislation of new psychoactive drugs
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... basic skeleton, which dramatically increases the number of possible chemical analogues to 100 or more. Moreover, most chemical compounds have a three-dimensional structure that can deform, which implicates additional variations of the parent compound. Analogues with a deviant three-dimensional struc ...
extemporaneous dosage form for oral liquids
extemporaneous dosage form for oral liquids

... pediatric use are compounded in various situations, including pharmacies in hospitals, nursing homes, and the community. Some have official monographs in the USP and may be published in the peer-reviewed literature. Before any USP monograph can be developed, however, valid stability studies must be ...
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Generic legislation of new psychoactive drugs
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... basic skeleton, which dramatically increases the number of possible chemical analogues to 100 or more. Moreover, most chemical compounds have a three-dimensional structure that can deform, which implicates additional variations of the parent compound. Analogues with a deviant three-dimensional struc ...
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... target and the subsequent usage of the PET radionuclide. This allows the production of PET radionuclides in gaseous, solid, and solution phases. Radionuclide generators offer an alternative method for point-of-use access to some PET radionuclides. A radionuclide generator contains an immobilized par ...
Simultaneous Separation of Different Types of Amphetamine and
Simultaneous Separation of Different Types of Amphetamine and

... abuse, 1-benzylpiperazine (BZP) and 1-(3-trifluoromethylphenyl)piperazine (TFMPP), will remain on the emergency schedule list until further ruling can be made regarding their hazards to public safety. Over the last few years these two compounds, and related analogs, have emerged as “legal” substitute ...
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Contamination of Herbal Medicines
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... toxic natural compounds were present in 14 preparations used for the treatment of skin conditions or indigestion . – Strikingly high amounts of heavy metals were identified in 39 samples. The levels of arsenic ranged from 522 to 161, 600 ppm in remedies used for treating leukemia, and the content of ...
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Drug Metabolism and Individualized Medicine
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... variation. There were three major ethnic groups: the Negroid, Mongoloid and Caucasoid. Ethnicity can be further narrowed to geography, anthropology, language, and race [45]. These studies of populations and incidence were first carried out mainly by chance or just because investigators were curious ...
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... Drug Excretion • Largely the domain of the kidney – Minor pathways: bile, lung, and feces • Common issue for drug dosing in the ICU – 7%-25% ICU population develop significant acute kidney injury and many more have pre-existing chronic kidney disease – Age-related changes in organ function includin ...
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION

... agents, LSF is being developed to prevent or reduce the incidence of serious and fatal infections, mucositis and treatment-related mortality. More than 578 people have participated in over 15 clinical trials of LSF as of September 30, 1997. The Company has completed two Phase II trials for LSF which ...
Angelo G. Sargenti: Madman or Messiah?
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... AAE aware of a significant number of patients who have suffered injuries as a result of treatment with filling materials and sealers containing paraformaldehyde.” Oddly, the AAE looks to litigation instead of the scientific literature to stay informed. In reality, litigation involving gutta percha-b ...
www.ijpbs.com Rishikesh S Deshmukh*et al Int J Pharm Bio Sci
www.ijpbs.com Rishikesh S Deshmukh*et al Int J Pharm Bio Sci

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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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