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QUALITY BY DESIGN IN INHALATION PRODUCT DEVELOPMENT
QUALITY BY DESIGN IN INHALATION PRODUCT DEVELOPMENT

... essential to start by understanding the input materials, formulation, container closure systems, and process variables, and how these affect the critical quality attributes and therefore the finished product’s performance within the design space. The operating space is used to define the range for t ...
(continued): Many commercially available liquid preparations are
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... • No specific antidote for any of the new OACs – New agents in development may solve this problem • Activated charcoal will reduce drug absorption if administered within a few hours of ingestion • Rivaroxaban & apixaban effect may be reversed by giving prothrombin complex concentrate (PCC) (limited ...
The Treatment of Hyperkalemia - Georgia Society of Health
The Treatment of Hyperkalemia - Georgia Society of Health

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safety data sheet - Nephron Pharmaceuticals Corporation

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... Furthermore, a group of patients was successfully treated with a lower dose (300 mg) of linezolid. The proportion of adverse events was >80% but was less elevated in the group of individuals exposed to 300 mg once a day [32, 33]. In the current issue of the European Respiratory Journal, an important ...
DEVELOPMENT OF SUSTAINED RELEASE MATRIX TABLET OF TRAMADOL HYDROCHLORIDE  Research Article
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... objectives of ensuring safety and improving efficacy of drugs as well as patient compliance, which can be achieved by better control of plasma drug levels and less frequent dosing1. Physical blending of drug with polymer matrix, followed by direct compression, compression molding, injection molding, ...
A. INTRODUCTION 1. History of Use of Traditional Herbal Medicines
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Adverse drug reactions: definitions, diagnosis, and management

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Research Chemicals - KFx Drug Consultancy Initiative

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... Expertise in drug formulation, development, scale-up & manufacture • More than 30 products launched in 100+ countries • 15 products in clinical development • Extensive product development, scale-up and manufacturing capabilities in US and EU ...
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Elan Drug Technology

... Expertise in drug formulation, development, scale-up & manufacture • More than 30 products launched in 100+ countries • 15 products in clinical development • Extensive product development, scale-up and manufacturing capabilities in US and EU ...
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Pharmacology
Pharmacology

... pediatrics) and many other disciplines. Pharmacology is characterized by wide range of contents and profound theories, making it an indispensable course for medical and pharmaceutical research as well as clinical and production practice. The goal of pharmacology includes: 1) to clarify the action of ...
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... In addition, Metabolize has devoted a significant amount of time and resources to ensure that its products are safe and effective. First, Metabolize is one of two companies which invested in animal studies to evaluate the health effects of its products. These 1994 studies evaluated an herbal compoun ...
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... • The closer the pKa value to the pH of the body fluids (generally 7.4), the greater is the change in ionization degree. ...
Clinical Trial Guidelines - Pharmacy and Poisons Board
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achieving success in the sustained regeneration form of corporate
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... subject to similar development constraints. Issues such as time-to-market and cost of development are impacted by the drug testing and marketing regulations which are administered, in the United States for example, by the Food and Drugs Administration (FDA) (Tonkens, 2005). By focusing on the pharma ...
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... therapeutics. Prontosll (2, 4 - diaminoazobenzene - 4'-sulphanamide) introduced by Domagk in 1932 was the first chemotherapeutic agent active against bacteria. In spite of its therapeutic effects had no in vitro antibacterial activity. ...
ATOMOXETINE for ADHD
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CHIRALITY (AS PREFORMULATION ASPECTS) 
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... As the understanding of plants as drug sources became more sophisticated, researchers sought to isolate and intensify active components while avoiding harmful ones. The active components of plants vary in character and effect: • Alkaloids, the most active component in plants, react with acids to for ...
the role of promotion on marketing in turkish drug industry
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... Drug promotion is sensed as an important subject all arround the world. In our country, drugs are being marketed and promoted in a way forever years. But as in all sectors, some problems occur about promotion in drug sector. The main problem is the positive or negative effects on sector about the su ...
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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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