• Study Resource
  • Explore Categories
    • Arts & Humanities
    • Business
    • Engineering & Technology
    • Foreign Language
    • History
    • Math
    • Science
    • Social Science

    Top subcategories

    • Advanced Math
    • Algebra
    • Basic Math
    • Calculus
    • Geometry
    • Linear Algebra
    • Pre-Algebra
    • Pre-Calculus
    • Statistics And Probability
    • Trigonometry
    • other →

    Top subcategories

    • Astronomy
    • Astrophysics
    • Biology
    • Chemistry
    • Earth Science
    • Environmental Science
    • Health Science
    • Physics
    • other →

    Top subcategories

    • Anthropology
    • Law
    • Political Science
    • Psychology
    • Sociology
    • other →

    Top subcategories

    • Accounting
    • Economics
    • Finance
    • Management
    • other →

    Top subcategories

    • Aerospace Engineering
    • Bioengineering
    • Chemical Engineering
    • Civil Engineering
    • Computer Science
    • Electrical Engineering
    • Industrial Engineering
    • Mechanical Engineering
    • Web Design
    • other →

    Top subcategories

    • Architecture
    • Communications
    • English
    • Gender Studies
    • Music
    • Performing Arts
    • Philosophy
    • Religious Studies
    • Writing
    • other →

    Top subcategories

    • Ancient History
    • European History
    • US History
    • World History
    • other →

    Top subcategories

    • Croatian
    • Czech
    • Finnish
    • Greek
    • Hindi
    • Japanese
    • Korean
    • Persian
    • Swedish
    • Turkish
    • other →
 
Profile Documents Logout
Upload
Industrial Pharmacy II - Home|Faculty Members Websites|The
Industrial Pharmacy II - Home|Faculty Members Websites|The

... micelles swollen with solubilized oil and drug. The high surface area facilitates the rapid diffusion of drug from the dispersed oil phase into the aqueous intestinal fluids, until an equilibrium distribution is established. Then as drug is removed from the intestinal fluids via enterocyte absorptio ...
Herbal / Drug Interactions PHARM 512: Clinical Applications of Drug
Herbal / Drug Interactions PHARM 512: Clinical Applications of Drug

... – Product selection: want standardized extract containing about 0.3% hypericin or 1-2% hyperforin – Dose: about 300mg TID for treatment – Questions remaining include • How best to use this herbal given that there are drug interaction problems ...
the use of cardiovascular drugs in niš region of
the use of cardiovascular drugs in niš region of

... could be explained by widening of the indications for their use in hypertension, diabetic nephropathy, heart failure, etc. In the last decade ACE inhibitors became almost the most important drugs in cardiology, taking into consideration their cardioprotective and renoprotective effects (7). Many cli ...
dose - Recherche Clinique Paris Centre
dose - Recherche Clinique Paris Centre

... ● The aim of this study is to assess the effect of a repeated administration of the IP on the pharmacokinetic profile of a single dose of midazolam, in healthy male and female subjects ● Classification of CYP3A inhibitors • a single oral dose of midazolam allows discrimination between strong (≥ 5fol ...
- KoreaMed Synapse
- KoreaMed Synapse

... effects with such off-label uses. However, in most countries rational application of off-label uses have not been prohibited, since it may be the only available and perhaps the best possible treatment option. In contrast, in an effort to minimize such use and per se ‘protect’ children from possible ...
The Medicare amendment adopted late last year contains a
The Medicare amendment adopted late last year contains a

... Unfortunately, for most of these medications at the time they are launched, we know little about their effectiveness beyond comparison to a placebo. This is because, for the most part, the ability of a medicine to provide “efficacy” is still derived from randomized clinical trials and, under the cur ...
Hatch-Waxman Turns 30 - Yale Law School Legal Scholarship
Hatch-Waxman Turns 30 - Yale Law School Legal Scholarship

... the regulation of prescription drugs that hindered the ability of generic manufacturers to market low-cost copies of brand-name drugs. Prior to 1984, the most significant federal legislation affecting the pharmaceutical market was the 1962 Kefauver-Harris Amendments to the Food, Drug, and Cosmetic A ...
Guideline on Repeated Dose Toxicity Corr - EMA
Guideline on Repeated Dose Toxicity Corr - EMA

... Furthermore, the stability of the substance in the tested dose formulation should be known. The substance used in the repeated dose toxicity studies should present at least a similar pattern or levels ...
$doc.title

... deregulated  IL-­‐36  signalling  may  have  a  func6on  in  disease  pathology,  such  as   psoriasis.  Specifically,  direct  therapeu6c  u6lity  as  inhibitors  of  neutrophil  granule   protreases  (Cathepsin  G,  Elastase  and  proteinase   ...
Pharmacologyonline 1: 613-624 (2011) Thanigavelan et al.
Pharmacologyonline 1: 613-624 (2011) Thanigavelan et al.

... (Materia medica). 2. Suthi seithal (Purification and detoxification): This process removes impurities or deleterious properties of the raw drugs. If this is not done, these drugs may induce morbid symptoms/diseases. Mostly, these are purified by repeated ashing by Pudam or plunging in certain fluids ...
sensitive, selective and rapid high performance liquid
sensitive, selective and rapid high performance liquid

... reaction. A patient who receives a preparation in which an incompatibility has occurred could experience toxicity or an incomplete therapeutic effect.1 There are three types of incompatibilities 1. Physical incompatibility. 2. Chemical incompatibility. 3. Therapeutic incompatibility.2 Intravenous th ...
Next Generation Therapeutics for Disorders of Complement
Next Generation Therapeutics for Disorders of Complement

... This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the safety, efficacy and regulatory and clinical progress of our product candidates, including RA101495. All such fo ...
Timing and Characteristics of Cumulative Evidence Available on
Timing and Characteristics of Cumulative Evidence Available on

... or nonrandomized, (2) explored whether they evaluated the FDA-approved indications, and (3) documented the available treatment comparisons. We also meta-analyzed the difference in start times between randomized studies that (1) did or did not evaluate approved indications and (2) were or were not de ...
Distribution of Drug
Distribution of Drug

... specifically in one or more tissues that may or may not be the site of action. Ex: Iodine (in the thyroid gland), chloroquine (in the liver even at conc 1000 times those present in plasma), tetracycline (irreversibly bound to bone & developing teeth) & highly lipid soluble compounds (distribute into ...
.-4 L
.-4 L

... lovastatin rather than a food product, red yeast rice, containing a range of naturally beneficial constituents. The agency states that “Pharmanex purposely designed a manufacturing process intended to consistently maximize and standardize levels of Iovastatin in Cholestin. ” September 30 Letter at 4 ...
Chronobiology: Pulsatile Drug Delivery System
Chronobiology: Pulsatile Drug Delivery System

... suited for those where zero order release is not required. Keywords: Chronobiology, Circadian rhythm,Clock genes, Pulsatile drug delivery system ...
Ping Zhao CV
Ping Zhao CV

10 × `20 Progress—Development of New Drugs Active Against Gram
10 × `20 Progress—Development of New Drugs Active Against Gram

Pharmcokinetics in Critical Care
Pharmcokinetics in Critical Care

... – Tazocin 2.25 g IV q8h (plus top-up prn) – vancomycin 1 g IV (if level < 15 pre-dialysis) ...
Revised: August 2015 AN: 00612/2015 SUMMARY OF PRODUCT
Revised: August 2015 AN: 00612/2015 SUMMARY OF PRODUCT

Over-the-Counter Drugs
Over-the-Counter Drugs

Version 7, 08/2005
Version 7, 08/2005

... Do not exceed the recommended dose. Repeat injections should be made at different sites. The safety of the product has not been established in pigs or calves when administered by the intravenous route and use of this route of administration is not recommended in these animal groups. Official and loc ...
MP16z - Appendix 2 - NMP approval to practice form.dot
MP16z - Appendix 2 - NMP approval to practice form.dot

... Controlled Drug in Schedules 2, 3, or 4 is valid for 28 days from the date stated thereon. Prescriptions ordering ‘repeats’ on the same form are not permitted for Controlled Drugs in S2 or 3. Guidance (June 2006) issued by the Department of Health in England on prescribing and dispensing of Controll ...
Ephedra - Living Heart Foundation
Ephedra - Living Heart Foundation

Preclinical Toxicology of Anticancer Agents
Preclinical Toxicology of Anticancer Agents

... to a uniform schedule of daily treatment for 5 consecutive days. This analysis demonstrated that mouse, rat, dog, monkey, and man have essentially the same MTD when compared on a basis of mg/sq m of body surface area. The study suggested that Phase 1 clinical trials could be safely initiated at a do ...
< 1 ... 58 59 60 61 62 63 64 65 66 ... 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.
  • studyres.com © 2025
  • DMCA
  • Privacy
  • Terms
  • Report