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Topic Review
Synthetic Cathinones and Synthetic Cannabinoids
Novel psychoactive substances (NPS) are compounds of natural and synthetic origin, similar to traditional drugs of abuse. NPS are involved in a contemporary trend whose origin lies in a thinner balance between legitimate therapeutic drug research and legislative control. The contemporary NPS trend resulted from the replacement of MDMA by synthetic cathinones in ‘ecstasy’ during the 2000s. The most common NPS are synthetic cannabinoids and synthetic cathinones. Interestingly, during the last 50 years, these two classes of NPS have been the object of scientific research for a set of health conditions. 
  • 338
  • 06 May 2022
Topic Review
Transient Receptor Potential Ankyrin 1
The transient receptor potential ankyrin 1 (TRPA1), a member of the TRP superfamily of channels, is primarily localized in a subpopulation of primary sensory neurons of the trigeminal, vagal, and dorsal root ganglia, where its activation mediates neurogenic inflammatory responses. TRPA1 expression in resident tissue cells, inflammatory, and immune cells, through the indirect modulation of a large series of intracellular pathways, orchestrates a range of cellular processes, such as cytokine production, cell differentiation, and cytotoxicity. 
  • 647
  • 05 May 2022
Topic Review
UV Filters
The use of sunscreens is a recommended practice to protect skin from solar-induced damage. Around 30 UV filters can be used in sunscreen products in the European Union. However, low photostability and putative toxicity for humans and environment have been reported for some UV filters. Therefore, it is important to develop new UV filters with improved safety profile and photostability. Over the last two decades, nearly 200 new compounds have revealed promising photoprotection properties. The explored compounds were obtained through different approaches, including exploration of natural sources, synthetic pathways, and nanotechnology. Almost 50 natural products and around 140 synthetic derivatives have been studied aiming the discovery of novel, effective, and safer future photoprotective agents. 
  • 1.5K
  • 05 May 2022
Topic Review
Therapies of the Immune-Mediated Kidney Diseases
Therapy of immune-mediated kidney diseases has evolved during recent decades from the non-specific use of corticosteroids and antiproliferative agents (like cyclophosphamide or azathioprine), towards the use of more specific drugs with measurable pharmacokinetics, like calcineurin inhibitors (cyclosporine A and tacrolimus) and mycophenolate mofetil, to the treatment with biologic drugs targeting detailed specific receptors, like rituximab, eculizumab or abatacept. Moreover, the data coming from a molecular science revealed that several drugs, which have been previously used exclusively to modify the upregulated adaptive immune system, may also exert a local effect on the kidney microstructure and ameliorate the functional instability of podocytes, reducing the leak of protein into the urinary space. The innate immune system also became a target of new therapies, as its specific role in different kidney diseases has been de novo defined. Current therapy of several immune kidney diseases may now be personalized, based on the detailed diagnostic procedures, including molecular tests. However, in most cases there is still a space for standard therapies based on variable protocols including usage of steroids with the steroid-sparing agents. They are used as a first-line treatment, while modern biologic agents are selected as further steps in cases of lack of the efficacy or toxicity of the basic therapies. In several clinical settings, the biologic drugs are effective as the add-on therapy. 
  • 268
  • 05 May 2022
Topic Review
Paracetamol
Paracetamol (acetaminophen) is one of the most commonly prescribed drugs worldwide. Synthetized over 150 years ago, paracetamol is highly efficient as analgesic and antipyretic and is on the list of the World Health Organization’s essential medicines. Paracetamol is also a hypothermic agent.
  • 702
  • 28 Apr 2022
Topic Review
The Development Perspective and Recommendations of Biosimilars
Making biosimilars accessible means reducing their cost of development, which is currently at around USD 100–200 million, keeping small and medium-size companies out of play and leaving most current biosimilars in the hands of big pharma. How this cost breaks down is an interesting subject.
  • 461
  • 27 Apr 2022
Topic Review
Clinical Efficacy and Safety, Interchangeability of Biosimilars
Clinical safety and efficacy studies add substantial cost and time to the approval of biosimilars. However, this argument will have little weight if these studies were able to add additional value over and above the rest of the testing. Interchangeability is a legally defined path in the US biosimilar guidance.
  • 365
  • 27 Apr 2022
Topic Review
Pharmacology of Biosimilars
Testing in animals is an old routine used for new drugs to avoid serious toxicity to humans. However, biological drugs may not always show a pharmacologic response in animal species; thus, the toxicity is an extension of the pharmacological response for biological drugs. Clinical pharmacology comparisons comprise the most relevant testing to support the biosimilarity of a biosimilar candidate. When a novel drug is developed, PK/PD testing is carried out on many volunteers to understand the diversity of disposition in terms of gender, age, and genetic distribution.
  • 569
  • 27 Apr 2022
Topic Review
Analytical Assessment of Biosimilars
The analytical assessment includes testing physicochemical and functional attributes to establish a claim of biosimilarity. How closely a biosimilar candidate should match the reference product will remain questionable since a reference product is approved based on whatever quality attributes it presents; a biosimilar candidate, on the other hand, must match these quality attributes, even if the reference product’s attributes are not the most desirable.
  • 1.5K
  • 27 Apr 2022
Topic Review
Regulatory Pathway of Biosimilar
While most biosimilars have rigidly followed the WAC pricing of 3–30% below the reference product in the US, we can anticipate significant price drops in the future. Since the US market represents 40% of the world market, price drops in the US are pivotal in presenting the overall benefits of biosimilars. In the EU, the pricing of biosimilars is a regional issue, presenting a range of 30 to 70% of market share and price drops of up to 85%, with Norway, Denmark, and Italy leading the reductions. The success of biosimilars in Europe was due to them achieving widespread acceptance by payers, providers, and patients as an integral part of medicine through an extensive program involving preparing stakeholders, investing in evidence generation (e.g., the NorSwitch trial), and introducing incentive models to share payer savings with hospitals. A key component of this success was forced switching, which is not possible on legal grounds in some countries and due to commercial interest in others.
  • 1.1K
  • 27 Apr 2022
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