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Hidden Dangers: Herbal and Dietary Supplement Induced
Hidden Dangers: Herbal and Dietary Supplement Induced

... purple foxglove, vincristine from Madagascar periwinkle and many others. It is estimated that 25 to 40% of modern prescription drugs contain at least one compound now or once derived from or patterned after those found in plants. Nearly 70% of antimicrobials and 50% of anticancer drugs developed in ...
Vaccines: `Safest of Medicines` or the `Biggest Lie`
Vaccines: `Safest of Medicines` or the `Biggest Lie`

... package insert to comply with the FDA's labeling regulations as set forth in 21 C.F.R. §§ 201.56(d) and 201.57, when the package insert complies thereto or, for “older format” package inserts, appropriately addressed, as required in 1979 by the regulations set forth in then 21 C.F.R. §§ 201.56(e) an ...
Document
Document

... dosing, and 3 overdoses because of selection of the wrong product. There were 3 reports of oral Methotrexate prescribing incidents reported to the risk management department over this period. All were related to the drug being prescribed on a daily schedule. In the twelve months 1st July 2002 until ...
Pharmacological drugs inducing ototoxicity, vestibular symptoms
Pharmacological drugs inducing ototoxicity, vestibular symptoms

... The panorama of the pharmacological origin iatrogenic noxae able to induce either harmful ototoxic effects or just a symptomatology like tinnitus or balance disturbances, without any harmful consequence, has widened in the last few years. The reason for this is the progress of scientific knowledge, ...
Patient Registries and Participating in Clinical Trials
Patient Registries and Participating in Clinical Trials

... Trial Must Make It Accessible To All Ataxia Patients. • Design trials that can use the fewest patients over the shortest period of time (this usually means testing better drugs and using biomarkers). • What is the rationale for excluding certain patients? Can those excluded be used in other ways? Pa ...
Pharmaceutical Development Case Study: “ACE Tablets”
Pharmaceutical Development Case Study: “ACE Tablets”

... March 13, 2008  ...
PrKETOTIFEN OPHTHALMIC SOLUTION
PrKETOTIFEN OPHTHALMIC SOLUTION

Annexures of Minutes of 14th Meeting
Annexures of Minutes of 14th Meeting

... production of drugs under hygienic conditions and should be free from cobwebs and insects/rodents. It should have adequate provision of light and ventilation. The floor and the walls should not be damp or moist. The premises used for manufacturing, processing, packaging and labeling will be in confo ...
Checking Drug Sensitivity of Cell Lines Used in Signatures
Checking Drug Sensitivity of Cell Lines Used in Signatures

Comparison of Inhaled Corticosteroids: An Update
Comparison of Inhaled Corticosteroids: An Update

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RISK PROFILE of acetanilide

... A concentration of 5 % for the sport massage balm yields a lower MoS than acceptable – by reducing the concentration in product down to 2.5 % we achieve the required MoS of 10. At a concentration of 2.5 %, and assuming that the sport massage balm is used on eighth of the legs and arms and half the a ...
annual review 2011
annual review 2011

... performance through marketing efforts for its drugs, including the sector’s leading drug for hyperlipidemia (Epadel). One main focus for the future will be on treatment and medical care for cardiovascular diseases, including hyperlipidemia. As a result, we expect to achieve steady growth. ...
Ilotycin - Perrigo
Ilotycin - Perrigo

... CONTRAINDICATION: This drug is contraindicated in patients with a history of hypersensitivity to erythromycin. PRECAUTIONS: General: The use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such a case, antibiotic administration should be ...
Compounded Topical Anesthetics in Orthodontics
Compounded Topical Anesthetics in Orthodontics

... Regardless of brand name, mucosal compound topical anesthetics are relatively similar. Each contains a combination of high-dose anesthetics, including both ester-type (tetracaine) and amide-type (lidocaine and prilocaine), to provide profound numbness, as well as other inactive ingredients for struc ...
Chemical, pharmacokinetic and pharmacodynamic properties of
Chemical, pharmacokinetic and pharmacodynamic properties of

here - Patent Docs
here - Patent Docs

... amphetamine base salts, such as the four amphetamine-salt combination of Adderall®, wherein the dosage form contains an both immediate-release and a delayed enteric release dose that is: (1) allegedly sufficient to maintain an effective level of amphetamine base salts in the patient over the course ...
chapter 1 - The Innovative Pharmaceutical Association South Africa
chapter 1 - The Innovative Pharmaceutical Association South Africa

... the active ingredients in a chemical plant and is closely similar to - indeed can be considered part of - the fine chemical industry which also covers chemicals for such products as dyes and pesticides. ...
Review of cough and cold medicines in children
Review of cough and cold medicines in children

... MIMS Volume 45 No 3 (June/July 2008) and MIMS on-line list over 130 products in the category expectorants, antitussives, mucolytics and decongestants. Doses for children aged less than 12 years are supplied on the labels of more than 70 of these medicines, which are mostly scheduled as S2 (pharmacy ...
In Vitro Metabolism of Haloperidol and Sila-Haloperidol
In Vitro Metabolism of Haloperidol and Sila-Haloperidol

... Liquid Chromatography/Mass Spectrometry Method. The samples were analyzed by liquid chromatography (LC) [Waters ACQUITY ultraperformance LC (UPLC), Milford, MA] on a Waters ACQUITY UPLC bridged ethyl hybrid (C18 2.1 ⫻ 50 mm, 1.7 ␮m) column at a flow rate of 750 ␮l/min (the column temperature was set ...
Curcuminoid drug interactions
Curcuminoid drug interactions

... valuable in the prevention and treatment of many different degenerative diseases. As curcuminoids are often taken as supplements by some population groups, it may be asked whether this can lead to changes in the pharmacokinetics or pharmacodynamics of other drugs taken at the same time. It is partic ...
Liquid Chromatography/Tandem Mass Spectrometry Detection of
Liquid Chromatography/Tandem Mass Spectrometry Detection of

... molecular ion with an m/z of 515.2. The reconstructed ion chromatogram of the summed ions corresponding to specific fragments of the synthetic adduct revealed the presence of two NAPQI-CPF adducts in the reaction mixture (peaks 1 and 2 in Fig. 3A). Their product ion spectra were comparable with that ...
Pot Marigold - Natural Know How
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Chapter Pharmaceutical Compounding – Nonsterile

... • therapeutic appropriateness and route of administration, including local and systemic biological disposition • legal limitations, if any 2. A Master Formulation Record should be created before compounding a preparation for the first time. This record shall be followed each time that preparation is ...
Herbal Remedies: The Design of a New Course in Pharmacy
Herbal Remedies: The Design of a New Course in Pharmacy

... At Northeast Louisiana University (NLU) School of Pharmacy, we have been involved in designing an elective course on herbs to fill the existing gap in our curriculum regarding the Use of herbs as alternative therapies. Like many other pharmacy curricula in the U.S., our curriculum covers natural pro ...
VA Medicaid PDL List (effective 07/01/2011)
VA Medicaid PDL List (effective 07/01/2011)

... o Patient’s condition is clinically unstable; changing to a medication not requiring service approval might cause deterioration of the patient’s condition. Document clinically compelling information 2. The requested medication may be approved if both of the following are true: 1. If there has been a ...
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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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