• 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
Bioisosteres
Bioisosteres

Medicinal Chemistry
Medicinal Chemistry

... The number of chemicals that have some kind of action on biological organisms is huge, while only a few thousand molecules are actually used as drugs. This is due to the fact that, to exert its action, an active principle has to be put in the necessary conditions to reach its target. The identificat ...
Companion Diagnostics Points to Consider
Companion Diagnostics Points to Consider

...  With companion diagnostics, the clinical validity is supported by the drug trial.  Training Set should be distinct from validation sample set  Analytical validation precedes clinical validation  Clinical decision points should be finalized prior to use in pivotal trial  The test is typically v ...
2015 Preferred Drug List Exclusions
2015 Preferred Drug List Exclusions

... 2015 Preferred Drug List Exclusions The excluded medications shown below are not covered on the Express Scripts drug list. In most cases, if you fill a prescription for one of these drugs, you will pay the full retail price. Take action to avoid paying full price. If you are currently using one of t ...
AdvaMed Medical Technology Learning Institute
AdvaMed Medical Technology Learning Institute

... describe at which point both sets apply – When two or more constituent parts that are to be included in a CP arrive at, or are manufactured at, same facility – Has been primary concern for industry – Should also be in a codified definition ...
December - National Association of Boards of Pharmacy
December - National Association of Boards of Pharmacy

... www.ismp.org/sc?id=337. The white paper supports mL as the standard unit of liquid measure used on prescription container labels for oral liquid medications. It also calls for dosing devices with numeric graduations, and for units that correspond to the container labeling to be easily and universall ...
Luitpold Animal Health - Luitpold Pharmaceuticals
Luitpold Animal Health - Luitpold Pharmaceuticals

... veterinarian. Each 5 mL contains 500 mg Polysulfated Glycosaminoglycan. Brief Summary Indications: For the intramuscular treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. For the intra-articular treatment of no ...
Comprehensive List Of Guidances
Comprehensive List Of Guidances

... Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies ...
Respiratory Drugs 2 - Suny-perfusion
Respiratory Drugs 2 - Suny-perfusion

... • Some drug companies are concerned that the Federal regulations regarding pseudoephedrine may keep people from buying their products, so they have reformulated their products by removing the pseudoephedrine and substituting phenylephrine for it. ...
Our Mission - Angelo State University
Our Mission - Angelo State University

... 1. Companies are NOT required to prove claims about safety or effectiveness 2. Products are NOT regulated to ensure quality control 3. Active ingredients vary greatly from product to product 4. Products usually do NOT undergo strict clinical trials ...
Slides
Slides

... solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. The presentation of these materials does not establish any form of attorney-client relationship. While every attempt was made to insure that these materials are accurate, errors or omis ...
Pharmacokinetics
Pharmacokinetics

Ethiopia
Ethiopia

... 80% of sites use stock cards but only 53% of sites regularly update and 47% report stock status ...
RL 4 Chiral drugs
RL 4 Chiral drugs

ahmet-inal-erciyes-university-turkey-61260428
ahmet-inal-erciyes-university-turkey-61260428

L8 Pharmacology PPt - Moodle
L8 Pharmacology PPt - Moodle

"Off-Label" Drug Use - Consumer Reports Health
"Off-Label" Drug Use - Consumer Reports Health

Introduction to Basic Therapeutics Module
Introduction to Basic Therapeutics Module

When Is an Interaction Likely to Cause Harm?
When Is an Interaction Likely to Cause Harm?

Therapeutic Drug Monitoring and Pharmacogenetics
Therapeutic Drug Monitoring and Pharmacogenetics

Issue 3
Issue 3

NTBC - International Conference on Rare Diseases and Orphan Drugs
NTBC - International Conference on Rare Diseases and Orphan Drugs

Understanding Abused Drugs Testing Results
Understanding Abused Drugs Testing Results

... Lab Test Results Suggest Majority of Patients Do Not Take Prescription Drugs as Prescribed A large percentage of patients do not take their prescription drugs as prescribed, according to data from Quest Diagnostics prescription drug monitoring service. Of 151,405 urine test results from patients ref ...
Basic Nursing: Foundations of Skills and Concepts Chapter 24
Basic Nursing: Foundations of Skills and Concepts Chapter 24

... absorption, excretion, or use in the body of one or more nutrients.  Certain foods may increase or decrease the absorption of a drug into the body.  Other foods may alter the chemical actions of drugs, preventing their therapeutic effect on the body. ...
Revised 10 September 2008 AN:00250/2008 SUMMARY OF
Revised 10 September 2008 AN:00250/2008 SUMMARY OF

... worms in dogs and cats. Chemically, Piperazine is diethylene diamine. The hexahydrate is physically unstable being very deliquescent, and consequently the drug is used in the form of the more stable salts. The adipate, citrate, hydrochloride, phosphate, sulphate and tartrate salts are white crystall ...
< 1 ... 113 114 115 116 117 118 119 120 121 ... 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