• 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
Nervous System
Nervous System

... Distribution • Refers to factors influencing a drug’s ability to get to its site of action after absorption ...
Syllabus for GPAT - 2013 PHARMACEUTICS
Syllabus for GPAT - 2013 PHARMACEUTICS

... applications.Development of hybridoma for monoclonal antibodies. Study of drugs produced by biotechnology such as Activase, Humulin, Humatrope, HB etc. Antibiotics: Historical development of antibiotics. Antimicrobial spectrum and methods used for their standardization. Screening of soil for organis ...
View
View

... applications.Development of hybridoma for monoclonal antibodies. Study of drugs produced by biotechnology such as Activase, Humulin, Humatrope, HB etc. Antibiotics: Historical development of antibiotics. Antimicrobial spectrum and methods used for their standardization. Screening of soil for organis ...
Basic-Pharm-161-Presentation-pharmacokinetics1
Basic-Pharm-161-Presentation-pharmacokinetics1

...  Drugs carry risk of causing birth defects o Teratogen= any substance that causes abnormal development of the fetus leading to a severely deformed ...
Bergström_Regulatory Biopharmaceutics 2017
Bergström_Regulatory Biopharmaceutics 2017

... • Example: Increase or reduction in colouring system. IA – Conditions, e.g.: • No change in disintegration/dissolution profile • Minor adjustment of formulation to maintain total weight should be made by ingredient which currently makes up a major part of the formulation ...
animal models of human diseases and their significance for clinical
animal models of human diseases and their significance for clinical

Public release of clinical information in drug submissions and
Public release of clinical information in drug submissions and

... and the basis for decisions on whether or not to exercise this authority. The Food and Drugs Act also permits the Governor in Council to make regulations that specify the business information obtained under the Act that is not CBI or the circumstances in which it ceases to be CBI. It also permits a ...
PDF
PDF

... Beverage Association, 2011). According to the U.S. Department of Labor, Bureau of Labor Statistics (2011), the consumer price index (CPI) for all urban consumers for non-alcoholic beverages is on the rise. Furthermore, there is a wide variation in non-alcoholic beverage prices in the United States b ...
What data can a 14C clinical study deliver?
What data can a 14C clinical study deliver?

... International client base (approx. 55% US, 40% EU, 5% RoW) ...
Preparing a Business Case for a New Medicine
Preparing a Business Case for a New Medicine

... e. For medicines that have an unusually wide usage (and a significant cost pressure) may need to take a more corporate approach. Seek advice of MRG committee members for guidance e.g. fidaxomicin antibiotic for C.Difficile f. Where a medicine is low cost, a “must do” e.g. as per NICE and trust wide ...
pharmaceutical factors
pharmaceutical factors

... Consumption and efficiency of drugs production can be described from quantitative and high-quality sides. So, a quantitative side appears by annual pharmacy and factory production of medicines. With respect to high-quality estimation, it has both positive and negative sides. Estimating positive side ...
ClinAccess: A Client/Server Approach to Clinical Trials Data Management and Regulatory Approval
ClinAccess: A Client/Server Approach to Clinical Trials Data Management and Regulatory Approval

... validation, and audit trails. One or more users are identified to CUNAcCESS as Database Administrators (DBA). To protect the integrity of the data, only the DBA's have access to a subsystem of CLiNAcCESS which is used to: create study libraries, define new studies to the system, manage existing stud ...
Principles of Drugs
Principles of Drugs

... from the liver into the circulation. • A drug given via the oral route may be extensively metabolized by the liver before reaching the systemic circulation (high firstpass effect). • The same drug—given IV—bypasses the liver, preventing the first-pass effect from taking place, and more drug reaches ...
6.0 BRIEF RESUME OF THE INTENDED WORK: 6.1
6.0 BRIEF RESUME OF THE INTENDED WORK: 6.1

... regulatory bodies Food And Drug Administration (FDA), European Medicines Agency (EMEA). Such therapeutic substances may be broadly classified into pharmaceuticals and bio-pharmaceuticals. The pharmaceuticals may be produced by chemical synthesis while biopharmaceutical products may be produced by ex ...
Fact Sheet
Fact Sheet

... Eating and drinking unpasteurized milk and dairy products can lead to health concerns due to contamination with various bacteria. Pasteurization improves food safety and lengthens product shelf life. ...
June - Acetylon Pharmaceuticals
June - Acetylon Pharmaceuticals

... accumulation of excess protein and in addition may disrupt critical proliferative signals in malignant cells.  Disruption  of  these  molecular  processes  in  cancer  cells  triggers  programmed  cell  death,  called  "apoptosis,"  with  little  or  no  effect  on  normal  cells.  Currently  availa ...
Product Name: Ibuprofen Oral Suspension 100mg/5mL
Product Name: Ibuprofen Oral Suspension 100mg/5mL

... 1ug/mL did not demonstrate ibuprofen in the milk of lactating mothers. Because of the limited nature of these studies, however, and the possible adverse effects of prostaglandin inhibiting drugs on newborns, this drug is not recommended for use in nursing mothers. The safety and effectiveness in ped ...
B.Pharm Revised 2003-04 Final Year With Elective Subject
B.Pharm Revised 2003-04 Final Year With Elective Subject

... Study of prodrugs in solving problems related to stability, bioavailability and elegance of formulations. Design development and process validation methods for pharmaceutical operations involved in the production of pharmaceutical products with special reference to tablets, suspensions. Prospective ...
A CROSS-SECTIONAL, OBSERVATIONAL, PROSPECTIVE STUDY FOR EVALUATION OF
A CROSS-SECTIONAL, OBSERVATIONAL, PROSPECTIVE STUDY FOR EVALUATION OF

... Background and Objective: Rational use of drugs is well recognized as an important part of health policy. Pregnancy is a special physiological condition, where rational drug treatment presents a special concern because the physiology of pregnancy affects the pharmacokinetics of medications used and ...
160-65-27 Eloctate Antihemophilic Factor Recombinant BDD FC
160-65-27 Eloctate Antihemophilic Factor Recombinant BDD FC

... Produced by recombinant DNA technology in a human embryonic kidney cell line. The cell culture medium does not contain any proteins derived from animal or human sources. Fc Fusion delays lysosomal degradation which allows for longer plasma half-life. The purification process utilizes a series of chr ...
Coding Systems - HeliosComp.com
Coding Systems - HeliosComp.com

Crescendo Biologics Appoints Edward J. Stewart as Chief Business
Crescendo Biologics Appoints Edward J. Stewart as Chief Business

... Crescendo is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Touchstone Innovations (formerly known as Imperial Innovations), Takeda and Astellas. For more information, please visit the website: www.crescendobiologics.com. About Humabody® Therapeutics Hum ...
VI.2 Elements for a Public Summary VI.2.1 Overview of disease
VI.2 Elements for a Public Summary VI.2.1 Overview of disease

... and the reference drug sequentially separated by a reasonable period known as washout period. They receive either test drug first followed by the reference drug or the reference drug first followed by the test drug in a random order. Blood concentrations of the drug are RMP Olmesartan medoxomil Jubi ...
Illicit Internet availability of drugs subject to recall and patient safety
Illicit Internet availability of drugs subject to recall and patient safety

... the post-marketing phase is not necessarily uncommon [2]. This includes the recall of ‘‘blockbuster’’ drugs that have been prescribed to million of patients worldwide, subsequently being removed from the market due to serious safety concerns [3]. Yet, effectively coordinating the permanent removal o ...
Drug Deletions - Texas Department of State Health Services
Drug Deletions - Texas Department of State Health Services

... docusate sodium with casanthranol ipecac ...
< 1 ... 99 100 101 102 103 104 105 106 107 ... 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