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Health-Based-Exposure Limits (HBELs = PDEs) should beestablished for all medicinal products. The toxicological orpharmacological data, on which the HBEL calculation relies, requires periodicalre-assessment throughout a product’s lifecycle.

 

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原文地址:Town hall Meeting作者:Yvon
     Town hall Meeting,按照字面理解也可以大致猜测出这个词组的意思,就是企业高层和员工的一次面见。
     Hans van der Noordaa,Chairman of ING Insurance Asia/Pacific and Investment Management。
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与治疗等效性相关的几个概念

  1.药学等效性(Pharmaceutical Equivalents)

  如果两个药品具有相同的活性成分、剂型、给药途径相同,且具有相同规格或者浓度则认为两者药学等效。药学等效性药品被配制为具有相同剂型且包含相同剂量的活性成分,以满足相同、药典或其他适用标准(规格、质量、纯度及特性),但是它们在诸如形状、刻痕一致性、作用机制、包装、赋形剂(包括颜色、口味、防腐剂)、失效日期、特定限制、标识等特点上存在差异。

  2.药物替代品(Pharmaceutical Alternatives)

  如果药品含有相同的治疗基,但却包含不同的盐、酯、双治疗基,或不同的剂型或规格(如250mg的盐酸四环素胶囊VS.250mg的复合磷盐酸四环素胶囊;200mg的硫酸奎尼丁片剂VS.200mg的硫酸奎尼丁胶囊),则此类药品被视为药物替代品。缓释药品与

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Operator remains protected and external environment remains clean while removing contaminants stopped inside the old filter (HEPA) wrapped and secured inside the bag and ready for disposal after the process…

Allows working staff to change filter without getting in direct contact with contaminants (e.g. toxic powders, radioactive dust, viable organism, cancirogens…). Used filters are easily removed from the isolator structure wrapped inside a barrier material (containment bag) and external atmosphere remains uncontamined. Bag-in/bag-out filter replacing method can be available for filters with different shape and size.
Different filters are available on the market according to the required air flow: can be cylindrical, squared or rectangular, available in different sizes.

Example of cartridge replacemen

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​Translational research – often used interchangeably with translational medicine or translational science – is a highly interdisciplinary field, the primary goal of which is to coalesce assets of various natures within the individual pillars in order to improve the global healthcare system significantly. The goal of translational medicine is to combine disciplines, resources, expertise, and techniques within these pillars to promote enhancements in prevention, diagnosis, and therapies.[1] The term translational refers to the 'translation' of basic scientific findings in a laboratory setting into potential treatments for disease.

Translational research is defined by the European Society for Translational Medicine (EUSTM) as an interdisciplinary branch of the biomedical field supported by three main pillars: bench-side, bedside and community.[1]

It is defined for school based education by the Education Futures Collaboration (www.meshguide

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​drug class:药物分类 n. 

A drug class or medication class is a group of medications that may work in the same way, have a similar chemical structure, or are used to treat the same health condition.

Examples of Drug Classes

Antibiotics are a class of medications used to treat infections caused by bacteria. Some frequently prescribed antibiotics are amoxicillin and Zithromax (azithromycin). Antibiotics can be derived from naturally occurring compounds that inhibit bacterial growth.

Antibiotics can also be created synthetically. There are many different types of antibiotics including the following:

  • Beta-lactams, such as penicillins, cephalosporins, and carbapenems, which inhibit cell wall synthesis;
  • Drugs that interfere with protein synthesis, such as macrolides, tetracyclines, linezolid, and lincosamides;
  • Drugs that interfere with folate synthesis, such
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Therapeutic classes are a way of classifying medical drugs according to their functions. Each therapeutic class is a group of similar medications classified together because they are intended to treat the same medical conditions. These classifications are used by doctors and pharmacists when selecting appropriate treatments for patients. Commonly used classes include analgesics, which relieve pain; antibiotics, which kill bacterial infections; and anticonvulsants, which prevent seizures.

There are many different therapeutic classes. They commonly have names that describe their intended effects, such as antipsychotics, tranquilizers, and decongestants. A therapeutic class can also be named for its chemical method of action, as is the case for classes such as dopamine receptor antagonists, which inhibit the effects of the neurotransmitter dopamine by preventing it from bonding with cells, and beta-adrenergic antagonists, more popularly known as bet

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Therapeutic classes are a way of classifying medical drugs according to their functions. Each therapeutic class is a group of similar medications classified together because they are intended to treat the same medical conditions. These classifications are used by doctors and pharmacists when selecting appropriate treatments for patients. Commonly used classes include analgesics, which relieve pain; antibiotics, which kill bacterial infections; and anticonvulsants, which prevent seizures.

There are many different therapeutic classes. They commonly have names that describe their intended effects, such as antipsychotics, tranquilizers, and decongestants. A therapeutic class can also be named for its chemical method of action, as is the case for classes such as dopamine receptor antagonists, which inhibit the effects of the neurotransmitter dopamine by preventing it from bonding with cells, and beta-adrenergic antagonists, more popularly known as bet

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Barry A. Friedman, PhD LLC

THE FDA AND TurboEIR – HOW IT’S MANAGED AND MISMANAGED FORM FDA 483s

June 2, 2014 By Barry FriedmanLeave a Comment

TurboEIR is a FDA software program designed to standardize Form FDA 483s and Establishment Inspection Reports (EIR).  It was completely “rolled out” in October 2002. For each “Objectionable Condition” (FDA 483 Observation), TurboEIR requests the inspection team to choose a “canned” citation and then describe the details of the situation.  In addition, each “canned” citation cont

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