• 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
Can we predict good drugs ?
Can we predict good drugs ?

Application of Bioassay in the Safety and/or Quality Control of
Application of Bioassay in the Safety and/or Quality Control of

Chinese Traditional Medicines Face Crucial Challenges in the New
Chinese Traditional Medicines Face Crucial Challenges in the New

... according to the traditional medical theories, most of which are used in the form of formulations, such as traditional Chinese drugs, Mongolian medicines, Tibetan medicines, and Uighur medicines. Modern plant medicines (natural medicines) are defined as the drugs used under the guidance of the moder ...
Good Manufacturing Practice, WHO Prequalification Scheme and
Good Manufacturing Practice, WHO Prequalification Scheme and

... – NMRAs: group assessments have passed on skills and built trust among regulatory staff from same region. This is the experience in the East African Community (EAC). – Manufacturers: Experience in submitting PQ dossiers improves appreciation of regulatory requirements, the quality of dossiers receiv ...
ASSESSMENT OF PHARMACEUTICAL QUALITY CONTROL AND EQUIVALENCE OF VARIOUS
ASSESSMENT OF PHARMACEUTICAL QUALITY CONTROL AND EQUIVALENCE OF VARIOUS

... rapidly dissolving” because the active pharmaceutical ingredient release at time point 15 min was more than 85% so no statistical treatment is required hence are considered to be in- vitro equivalent without in -vivo evaluation. The percent relative standard deviation (% RSD) for all time points ful ...
FREE Sample Here
FREE Sample Here

... Which precaution is most important for the nurse to teach? a. “Drugs in this category reduce the effectiveness of oral contraceptives and you will need to switch to another form of birth control to prevent pregnancy.” b. “One side effect of drugs in this category is nausea, which will make morning s ...
acebutolol-drug-doc - Prime Academic Writers
acebutolol-drug-doc - Prime Academic Writers

... have the prescription of acebutolol drugs. The patient with any pulmonary disease should take less dose of acebutolol and with close monitoring. Acebutolol drug tends to block the receptors on the breathing passages; this narrowing of the airway thus making asthma worse. To the patient with diabetes ...
| Barriers to new drug development in respiratory disease Peter J. Barnes
| Barriers to new drug development in respiratory disease Peter J. Barnes

... Repurposing old drugs An attractive approach to accelerate drug discovery is to find new uses for existing drugs by screening them against novel targets [12, 13]. This means that if the drug is already on the market it avoids the problems of side-effects, which are often an issue for new chemical en ...
DEPARTMENT  OF  HEALTH  AND  HUMAN ...
DEPARTMENT OF HEALTH AND HUMAN ...

... reasonably be expected to be safe. If this requirement is not met, the dietary supplement is considered to be adulterated under 21 U.S.C. 342(f) (1) (B) because there is inadequate information to provide reasonable assurance that the new dietary ingredient does not present a significant or unreasona ...
Bromday_CDER_letter_Nov_30
Bromday_CDER_letter_Nov_30

... resubmit the supplement, addressing the deficiencies identified by the agency; (2) withdraw the supplement; (3) seek formal dispute resolution through one or more appeals above the division level; or (4) request an opportunity for a hearing. 3 On May 12, 2011, ISTA went directly to the fourth of the ...
PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) MODELING: AN INVESTIGATIONAL TOOL FOR DRUG DEVELOPMENT Review Article
PHARMACOKINETIC/PHARMACODYNAMIC (PK/PD) MODELING: AN INVESTIGATIONAL TOOL FOR DRUG DEVELOPMENT Review Article

... Fig. 1: Schematic representation of effect-concentration data pairs sampled in chronological order (indicated by arrows) a) Sigmoid curve in steady state condition. b and c are non-steady state conditions hysteric loops. b) Counter clockwise loops in the drug effect (E) vs plasma drug concentration. ...
-full page
-full page

... •  Allows use, growing, and possession up to certain limits •  May require dispensaries ...
MFA - asdera
MFA - asdera

... Most bioinformatics tools in genetics are based on the statistical methods that were feasible in the 20th century, where memory was scarce. Hence, most GWAS are analyzed one SNP at a time and, thus, can detect only recent (de novo) mutations (‘letters’), but not the common cis-epistatic risk factors ...
Off-Label Use of Pharmaceuticals: A Detection Controlled Estimation
Off-Label Use of Pharmaceuticals: A Detection Controlled Estimation

... rate of, generic entry.10 Now, a generic applicant may receive an Abbreviated New Drug Application (ANDA), permitting entry, by demonstrating that its product is bioequivalent to the branded product. The cost of an ANDA is a small fraction of that of an NDA. Generic entry has expanded so rapidly, th ...
Guideline on clinical development of fixed combination medicinal
Guideline on clinical development of fixed combination medicinal

... active substances of the fixed combination medicinal product are required to demonstrate that the fixed combination medicinal product has greater efficacy in comparison with the respective individual active substances. Superiority or ‘add on efficacy’ can only be claimed to active substances to whic ...
1 Diosynth Biotechnology – Riding the Biomanufacturing Wave
1 Diosynth Biotechnology – Riding the Biomanufacturing Wave

... pipeline. As of 2002, nearly 10% of existing drugs originated from biotechnology research, and close to 20% of R&D efforts in the drug industry were by biotech firms.19 The number of approvals to commence manufacturing of biopharmaceutical products by the US Food and Drug Administration (FDA) was 11 ...
Review Pharmacodynamic and pharmacokinetic interactions
Review Pharmacodynamic and pharmacokinetic interactions

praluent
praluent

... with CHD or CHD risk equivalent • In the post-hoc analysis, there was ...
CONVULSIVE TAILS
CONVULSIVE TAILS

... toxicity  Can only be given by IV route  Cannot be repeated  It not as effective as phenobarbitone DeToledo & Ramsay; Drug Saf 2000 Trieman et al; NEJM 1998 ...
Veterinary Antidotes and Availability: An Update Susan J. Bright
Veterinary Antidotes and Availability: An Update Susan J. Bright

An Overview of Herbal Ecstacy and Other Stimulants
An Overview of Herbal Ecstacy and Other Stimulants

FORMULATION AND EVALUATION OF GUAR GUM BASED COLON TARGETED TABLETS... SECNIDAZOLE AND ITS β-CYCLODEXTRIN COMPLEX TO TREAT AMOEBIASIS
FORMULATION AND EVALUATION OF GUAR GUM BASED COLON TARGETED TABLETS... SECNIDAZOLE AND ITS β-CYCLODEXTRIN COMPLEX TO TREAT AMOEBIASIS

... The present investigation was planned to formulate colon targeted tablets of Secnidazole using guar gum as matrix carrier. Also it was planned to improve the solubility of Secnidazole by forming inclusion complex with β-cyclodextrin. Different formulations were prepared by changing the concentration ...
GAO WOMEN’S HEALTH Women Sufficiently Represented in New
GAO WOMEN’S HEALTH Women Sufficiently Represented in New

... suffering such an arrhythmia after taking these drugs than do men, probably because (1) the interval between heart muscle contractions is naturally longer for women than for men and (2) male sex hormones moderate the heart muscle’s sensitivity to these drugs. We recently reported that four of the te ...
A B C D X
A B C D X

... • Animal studies show no evidence of harm; however no human studies have been conducted. • Animal studies show adverse events; however human studies have not shown an increased risk of fetal abnormalities. ...
Zofran - Physicians
Zofran - Physicians

... Prevention of nausea and vomiting associated with radiation treatment †FDA Approved Indication(s) ...
< 1 ... 68 69 70 71 72 73 74 75 76 ... 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