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Development of Discriminative Dissolution Media for Marketed
Development of Discriminative Dissolution Media for Marketed

... Based on this, in vitro dissolution may be vital in assessing in vivo performance. Dissolution testing serves as a tool to distinguish between acceptable and unacceptable products. It is also used to assess the lot-to-lot quality of a drug product and can guide the development of new formulations. I ...
Could Science-Based Regulation Make Tobacco Products Less
Could Science-Based Regulation Make Tobacco Products Less

... (e.g., cigarettes per day) and duration (e.g., years) of tobacco use. Addiction is the biological force that drives most tobacco users to patterns of persistent daily exposure to high levels of deadly tobacco toxins. The cornerstone of the FDA's evaluation of whether or not nicotine in tobacco met c ...
Crosslinked hydrogels—a promising class of insoluble solid
Crosslinked hydrogels—a promising class of insoluble solid

... good swelling solvent) to produce a homogenous binary one-phase system. In this case, the carrier plays an essential role in preserving the entrapped drug molecules in the amorphous state despite the fact that the exact mechanisms of crystallization inhibition in solid molecular dispersions are stil ...
MELOXICAM Veterinary—Systemic
MELOXICAM Veterinary—Systemic

AN: 01083/2014 Revised: December 2014 SUMMARY OF
AN: 01083/2014 Revised: December 2014 SUMMARY OF

... Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible fluoroquinolones should only be used based on susceptibility testing. Use of the product including use de ...
The Řie-Tozer Model of Drug D
The Řie-Tozer Model of Drug D

... Drugs that distribute extensively into peripheral organs and tissues can exhibit two- or multiexponential pharmacokinetic behavior. Following intravenous bolus administration, significant amounts of these drugs reach peripheral compartment during the initial distribution phase, and slow return to th ...
Introduction - Wiley-VCH
Introduction - Wiley-VCH

... steroids, antibiotics, and many other compounds from nature are unichiral. Another important aspect of many chiral molecules from nature is their homochirality. This means that related chiral molecules in the same chemical class usually have the same sense of chirality. For example, with rare except ...
WHO Drug Dictionary User Guide - User Group Portal
WHO Drug Dictionary User Guide - User Group Portal

... The world is getting more and more integrated – people travel more than ever and medicinal products are being sold over the internet without any geographical restrictions. This is important to keep in mind when collecting information about concomitant medication – drugs taken by the subjects may com ...
A Mechanistic Approach to Understanding the Factors Affecting
A Mechanistic Approach to Understanding the Factors Affecting

... across all species. This question is currently being explored by the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine. By understanding the relationship between a drug’s absorption, solubility, and dissolution characteristics, it is possible to define situations when in vitro di ...
Meta-analysis of Oral Triptan Therapy for Migraine: Number Needed
Meta-analysis of Oral Triptan Therapy for Migraine: Number Needed

... in the acute treatment of moderate to severe migraine has been the introduction of the 5-HT1B/1D agonists, a migraine-specific class of drugs known as triptans. The first triptan, sumatriptan, became available in the United States in 1993 as an injectable formulation. Later, it became available as a ...
Situation Report National Drug Intelligence Center Synthetic Cathinones (Bath Salts):
Situation Report National Drug Intelligence Center Synthetic Cathinones (Bath Salts):

... Synthetic cathinones, typically marketed as “bath salts” and “plant food,” are sold legally under various names (Ivory Wave, Blizzard, etc.) in most areas of the United States. The products are generally sold in retail establishments such as adult stores, independently owned convenience stores, gas ...
3 0 M a r c h 1 6 ,
3 0 M a r c h 1 6 ,

... is a delicate function factor, of the half-life of pseudoephedrine. Thus, the data clearly demonstrate that a flexible dosing schedule of every four (4) to six (6) hours is permissible and more reflective of the achievable blood levels than a fixed dosage of every six (6) hours. In addition, recent ...
Chirality and its Importance in Pharmaceutical Field- An
Chirality and its Importance in Pharmaceutical Field- An

Bioidentical Hormone Therapy
Bioidentical Hormone Therapy

... enopause, the permanent cessation of menstruation that results from loss of ovarian function, can occur naturally, surgically, or as the result of medical intervention.1 The change in hormonal milieu associated with perimenopause and menopause can lead to a wide variety of symptoms that may negative ...
Predicting Drug Metabolism - Cambridge Repository
Predicting Drug Metabolism - Cambridge Repository

CLSI 2014 AST Update - Log into your Online Media Solutions portal
CLSI 2014 AST Update - Log into your Online Media Solutions portal

... Comments, opinions, and evaluations expressed in this program do not constitute endorsement by APHL/CLSI. The APHL/CLSI does not authorize any program faculty to express personal opinion or evaluation as the position of APHL/CLSI. The use of trade names and commercial sources is for identification o ...
SYLLABUS FOR B. PHARM. - All India Council For Technical
SYLLABUS FOR B. PHARM. - All India Council For Technical

... The students should be introduced to the main analytical tools through demonstrations. They should have a clear understanding of a typical analytical balance, the requirements of a good balance, weights, care and use of balance, methods of ...
443 - The AIDS InfoNet
443 - The AIDS InfoNet

THIOCOLCHICOSIDE AS MUSCLE RELAXANT
THIOCOLCHICOSIDE AS MUSCLE RELAXANT

... relaxant Thiocolchicoside (Muscoril, Myoril, Neoflax) is a muscle relaxant with anti-inflammatory and analgesic effects. It acts as a competitive GABAA receptor antagonist and also inhibits glycine receptors with similar potency and nicotinic acetylcholine receptors to a much lesser extent. It has p ...
Novel Fluorescent Probes Detect Different Types Of CYP450
Novel Fluorescent Probes Detect Different Types Of CYP450

... interactions. Testing compounds early in drug discovery for these unwanted interactions will permit elimination of unsuitable compounds and chemical series from further drug development. With the everexpanding pool of candidate drugs and increasing number of hits emerging from primary screening this ...
POWERPOINT SPECIALS
POWERPOINT SPECIALS

... Preferred Brand with Discount Manufacturer discounts are increasing due to Express Scripts formulary control and number of ...
PDF full-Text - Journal of Investigational Allergology and Clinical
PDF full-Text - Journal of Investigational Allergology and Clinical

Using SAS® for Modeling and Simulation in Drug Development – A Review and Assessment of Some Available Tools
Using SAS® for Modeling and Simulation in Drug Development – A Review and Assessment of Some Available Tools

... Modeling and simulation within the context of clinical trials has become an important tool used in addressing a variety of considerations and is now a widely used component for improving the efficiency of drug development. It is recognized as a powerful tool that can be used to make drug development ...
establishing similarity between multisource betahistine
establishing similarity between multisource betahistine

A Comprehensive Strategy for Host Cell Protein Analysis in
A Comprehensive Strategy for Host Cell Protein Analysis in

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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.
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