• 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
A Peak at PK – An Introduction to Pharmacokinetics
A Peak at PK – An Introduction to Pharmacokinetics

FLUVIRIN [Influenza Vaccine (Surface Antigen, Inactivated) Ph. Eur
FLUVIRIN [Influenza Vaccine (Surface Antigen, Inactivated) Ph. Eur

... The product is prescription only and intended for adults and children. This was a stand-alone, national application for Fluvirin, containing Influenza Virus (Surface Antigen, Inactivated), submitted under Article 8.3 (i) of Directive 2001/83/EC. The application is for a fundamental change to an exis ...
54 What does “off-label use” mean?
54 What does “off-label use” mean?

... The FDA-approved use or uses for a medication are narrowly defined in the professional product label. These include the disease being treated, the dose, the duration of treatment, and the age group of patients for which the medication is intended. The professional product label, or package insert, i ...
rajiv gandhi university of health sciences
rajiv gandhi university of health sciences

... The inherent drawback of conventional liposome can be overcome by using a novel approach of surface modification by using sterically stabilized liposomes or “Stealth Liposome”. The most promising result of liposome modification were achieved for avoiding RES detection and prolonging retention in cir ...


... actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved. Forward-looking information is based on the opinions and estimates of management as at the date the information is given, and is based on information available to management at such time. ...
Can and should beta-lactams be given by continuous infusion
Can and should beta-lactams be given by continuous infusion

... » Need to account for protein binding due to intersubject variation ...
PDF
PDF

... (b) electrophysiological responses on cellular, tissue, and organ levels given appropriate data, and thus increasing confidence in risk assessment (and probability of success) of novel drug therapies. In the current review, we do not aim to compare the models of human cardiac physiology either from ...
CHPA Voluntary Codes and Guidelines
CHPA Voluntary Codes and Guidelines

... Manufacturers should select appropriate means to make the flag conspicuous consistent with their trade dress. Flag the Label for New Products Introduced Under Existing Brand Names Manufacturers of nonprescription medicines should flag the labels of all new products introduced under an existing brand ...
Sustained Release Formulations
Sustained Release Formulations

... float on top of gastric juice and delay their transfer out of stomach e.g. PABA  GI retention for drugs with poor absorption can be increased by enhancers.  Bioadhesive materials is made which has high affinity to the mucin coat.  A drug that is slowly absorbed is poor candidate for SRDF eg.,Gent ...
Outcomes-Based Drug Coverage in British Columbia
Outcomes-Based Drug Coverage in British Columbia

... increased use of newer, higher-price drugs, decisionmakers saw evidence-based coverage as an appropriate way to control the public drug plan’s costs while maintaining access to medicines of proven benefit.6 n Health Canada’s role. Prior to 1993 PharmaCare had accepted for coverage virtually any drug ...
Inhalation systems
Inhalation systems

Unmet Needs in Drug Delivery Technologies
Unmet Needs in Drug Delivery Technologies

... the body. These biological barriers, while serving an important purpose of regulating body’s metabolic functions, limit the drug dose that ultimately reaches the target site. Accordingly, many drugs fail to reach their full therapeutic potential. Our research aims at developing a fundamental underst ...
SuperTarget goes quantitative: update on drug–target interactions
SuperTarget goes quantitative: update on drug–target interactions

... and increases accessibility to other chemotherapeutic drugs (28). Therefore, it may be desirable to find specific inhibitors of VEGFR-2, which do not affect the other receptor subtype VEGFR-1. A general idea about the specificity of an inhibitor is provided by its IC50 value. This refers to the compoun ...
Adverse Drug Reactions: Common and Lesser Known
Adverse Drug Reactions: Common and Lesser Known

WHO Drug Information - World Health Organization
WHO Drug Information - World Health Organization

... heparin by chemical reaction leading to depolymerization and various changes in structure. Natural heparin is a sulfated polysaccharide (polyuronic acid), which is a mixture of components differing in chain length. LMW heparins also form mixtures of individual components that may differ in chain len ...
User`s ​​​Guide - BC Cancer Agency
User`s ​​​Guide - BC Cancer Agency

... • Health Canada approved indications and common unlabelled indications are included if applicable; however monographs may also be created for drugs which are not marketed in Canada. Note: drugs available through the Health Canada Special Access Program (and approved at BCCA through the Compassionate ...
Document
Document

... Prescriptions-Reading and understanding of prescription; Latin terms commonly used (Detailed study is not necessary), Modern methods of prescribing, adoption of metric system. Calculations involved in dispensing. (ii) Incompatibilities in Prescriptions-Study of various types of incompatibilities-phy ...
USA Product Label
USA Product Label

... Panacur® Granules 22.2% did not cause toxicity when administered to weaned pups at doses equal to 5 times the recommended daily dose and for 2 times the duration of treatment. ADVERSE REACTIONS Another benzimidazole has been reported to cause hepatoxicity clinically in canines. However, this effect ...
Natural products as starting points for future anti
Natural products as starting points for future anti

pharmaceuticals: restrictions in use and availability
pharmaceuticals: restrictions in use and availability

... effective date on which the regulation came into force; a summary of regulatory measures taken by governments; brief explanatory comments where necessary; and legal and bibliographical references. While the information cannot be regarded as exhaustive, either in terms of products or regulatory measu ...
Combinations student notes 10_lesson_combinationsStudent
Combinations student notes 10_lesson_combinationsStudent

... be the case for sedation. Caffeine stimulates wakefulness, while tranquilizers stimulate sleepiness. The drugs oppose each other with regard to inducing sleep/alertness. In fact, any drug pair that has opposite effects will exhibit antagonism. The main features of antagonism are that one or both dru ...
book chapter
book chapter

... medicine. Furthermore, a safe, efficacious, and patentable product could be produced. The scientists in Sinoveda understand the complexity of this task. We have spent more than 10 years to come up with PPT to tackle this problem. Our strategy is to start with herbs that have sporadic positive clinic ...
A new trend in drugs-of-abuse
A new trend in drugs-of-abuse

... 2C-series in a quite and friendly environment. They are in principal better informed and prepared, but could be misled by incorrect information as observed in this investigation and elsewhere 3, 16. Unfortunately, these users may try higher doses as well as more risky ways of administration such as ...
Drug Diversion Chaitali Chheda, PharmD candidate 2008 January 10, 2008
Drug Diversion Chaitali Chheda, PharmD candidate 2008 January 10, 2008

... pharmacy to inform them that her refill has not been entered. The pharmacist tells the patient to return to the pharmacy for a new label, and calls the ER doctor to see if the patient should receive refills. The doctor informs the pharmacist to call the police. ...
Drug removal rate
Drug removal rate

... ADMET – absorption, distribution, metabolism, elimination, toxicity ...
< 1 ... 85 86 87 88 89 90 91 92 93 ... 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