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Drug Discovery and Development
Drug Discovery and Development

... • The route must be suitable to the “scale up” needed for the production of at least tens of kilograms of final product • This may limit the structural complexity and/or ultimate size (i.e. mw) of the final product • In some cases, it may be useful to design microbial processes which produce highly ...
Paracetamol - Pediatric Oncall
Paracetamol - Pediatric Oncall

... According to WHO paracetamol is the drug of first choice* . Ibuprofen is a useful 2nd line drug. No other NSAID including Nimesulide should be prescribed for children with high grade fever and used with caution has been cleared by US FDA for using as antipyretic. * WHO 1990 ...
Summary of Product Characteristics
Summary of Product Characteristics

... Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats. No studies have been performed in dogs during early pregnancy. Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian. Bitches should not ...
How are drugs developed?
How are drugs developed?

What You Want to Know About Generic Drugs
What You Want to Know About Generic Drugs

... • may be supplied by more than one company • may be sold under active ingredient(s) name(s) ...
Methicillin-resistant Staphylococcus aureus (MRSA) Real
Methicillin-resistant Staphylococcus aureus (MRSA) Real

9-13-04 Factors Affecting Action of Drugs
9-13-04 Factors Affecting Action of Drugs

... – Drug is conjugated to glutathione • Increases the polarity of the drug even more • Phase II is not dependent on phase I although often happens after I ...
All You Wanted to Know About the Drug Fact Label
All You Wanted to Know About the Drug Fact Label

... ◦ How many times per day ◦ How many hours between doses  How long to use ...
Optimizing Drug Registration in China: Category I Route
Optimizing Drug Registration in China: Category I Route

... moiety can be accepted for review; developers who have approved CTAs for the same active moiety, however, are permitted to continue clinical trials and submit NDAs to review. These provisions function independently; a product may be granted an observation period that runs concurrently with its paten ...
TBD - Tel Aviv University
TBD - Tel Aviv University

... Drug Metabolism The chemical modification of drugs with the overall goal of getting rid of the drug Enzymes are typically involved in metabolism Drug ...
Phase I trials: A New era in OnCology drug development
Phase I trials: A New era in OnCology drug development

... model our drug development paradigms on those routinely used in other chronic diseases rather then trying to remodel our ancient oncology paradigms to fit modern oncology drugs.” • Dose-response should be an integral part of drug ...
Understanding Drugs and Medicines
Understanding Drugs and Medicines

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powerpoint

... comparison to their benefits are more desirable in the treatment of disease. ...
MOA Promotional Speaker Slide Kit
MOA Promotional Speaker Slide Kit

... • Requires Deliberation from team of experts: • Animal tox, Pharmacokinetics, PK/PD modeling, Clinical research, Preclinical pharmacology, (Biomarkers) ...
Food Safety News – 2014 Review Animal Antibiotics
Food Safety News – 2014 Review Animal Antibiotics

Vaccine Manufacture
Vaccine Manufacture

... The harvested allantoic fluid that contains the live virus are tested for virus infectivity, titer, specificity and sterility These fluids are then stored wet frozen at extremely low temperatures to maintain stability of the monovalent seed virus (MSV) The allantoic fluid is then harvested and purif ...
Powerpoint of Dr. Savage`s presentation at
Powerpoint of Dr. Savage`s presentation at

... we're finding this, one of the girls appeared to be really out of it, acting very, very strange." In the weeks before the incident, Roarick said at least one local store owner called the police to report that the store had been selling a lot of Benadryl. Roarick said he's advised store owners not to ...
Foundation Knowledge and Skills
Foundation Knowledge and Skills

...  Concentration of drug in blood  measured to help guide appropriate therapy  determines whether a change in therapy is needed  Examples of medications whose levels are measured  phenytoin, carbamazepine, valproic acid, phenobarbital  digoxin  gentamicin, tobramycin, vancomycin ...
Can-Fite BioPharma Ltd. (Form: 6-K, Received: 01/06
Can-Fite BioPharma Ltd. (Form: 6-K, Received: 01/06

... This presentation contains forward - looking statements, about Can - Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects . In addition, from time to time, Can Fite or ...
Sept 2006 - State Employee Information Center
Sept 2006 - State Employee Information Center

... midwest cities in the past few months. ...
June 3, 2007 - American University Washington College of Law
June 3, 2007 - American University Washington College of Law

...  Three year period of data exclusivity for drugs that are not NCEs, but required clinical testing for approval.  Non-concurrent periods of exclusivity if approval in one nation is based on approval in another ...
(butalbital-acetaminophen), butalbital-aspirin-caffeine
(butalbital-acetaminophen), butalbital-aspirin-caffeine

INDTRODUCTION - Chemical Engineering
INDTRODUCTION - Chemical Engineering

... amount of drug reaching bloodstream is equal to the area under the Cp vs t curve, AUC ...
click here for presentation
click here for presentation

... • Discuss new medications and their impact on  the elderly • Discuss new medications, adverse effects, or  restrictions for the general population ...
. ‘“% ? :  Tsf
. ‘“% ? : Tsf

... This is to inform you that the notification, dated April 2,2004, you submitted pursuant to 21 U.S.C. 350b(a)(2)(section413(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act)) on behalf of your client, Soft Gel Technologies, Inc. (SGTI) was filed by the Food and Drug Administration (FDA) on ...
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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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