scholarly journals Biotherapeutics and its applications in Microbiology

2021 ◽  
Vol 22 (SE) ◽  
pp. 63-78
Author(s):  
Navjot Kaur ◽  
Vishu Chaudhary
Keyword(s):  
Clinical Pharmacology ◽  
Monoclonal Antibodies ◽  
Pharmaceutical Industry ◽  
Major Part ◽  
Pharmaceutical Market ◽  
Assembly Process ◽  
New Drug ◽  
Pharmacology And Toxicology ◽  
Organic Source ◽  
The Way

Biotherapeutics is a rapidly growing segment of the entire pharmaceutical industry that constitutes approximately one-quarter of ongoing new drug endorsements. Monoclonal antibodies are a major part of these endorsements every year (mAbs). MAbs' non-clinical pharmacology and toxicology research compare with substance components during progression, since these biotherapeutics are extracted from an organic source, and to inspire a pharmacological reaction, the creature models must also have similar epitopes (focuses) as individuals. Biotherapeutic items (BTPs) are the quickest developing drugs in the pharmaceutical market. Despite their clinical achievement, the immunogenicity of BTPs keeps on being a significant concern. The subcutaneous (SC) course is to cultivate a passion for the organisation of biotherapeutics. Both monoclonal antibodies and various biotherapeutics are discussed. Medicine has been disrupted by biotherapeutic drugs (BPs), altering the way we treat a few processes. Comparative BPs (SBPs) are discussed here, also called biosimilars, including the assembly process and administrative viewpoints used. Monoclonal antibodies can apply synergistic antitumour impacts in blend with other immunomodulatory approaches, for example, chemotherapy, radiotherapy, directed treatment specialists, immunisations, or different immunomodulators. Probiotics have gotten profoundly perceived as enhancements for people and specifically for creatures given their gainful result on wellbeing improvement and prosperity support.

scholarly journals Biotherapeutics: Challenges and Opportunities for Predictive Toxicology of Monoclonal Antibodies

2018 ◽  
Vol 19 (11) ◽  
pp. 3685 ◽  
Author(s):  
Dale Johnson
Keyword(s):  
Clinical Pharmacology ◽  
Monoclonal Antibodies ◽  
Drug Reactions ◽  
Predictive Toxicology ◽  
Mechanisms Of Toxicity ◽  
Biological Source ◽  
Pharmacological Response ◽  
Challenges And Opportunities ◽  
New Methodologies ◽  
Pharmacology And Toxicology

Biotherapeutics are a rapidly growing portion of the total pharmaceutical market accounting for almost one-half of recent new drug approvals. A major portion of these approvals each year are monoclonal antibodies (mAbs). During development, non-clinical pharmacology and toxicology testing of mAbs differs from that done with chemical entities since these biotherapeutics are derived from a biological source and therefore the animal models must share the same epitopes (targets) as humans to elicit a pharmacological response. Mechanisms of toxicity of mAbs are both pharmacological and non-pharmacological in nature; however, standard in silico predictive toxicological methods used in research and development of chemical entities currently do not apply to these biotherapeutics. Challenges and potential opportunities exist for new methodologies to provide a more predictive program to assess and monitor potential adverse drug reactions of mAbs for specific patients before and during clinical trials and after market approval.

Determining the structure of pharmaceutical industry in Iran

2019 ◽  
Vol 13 (1) ◽  
pp. 101-115
Author(s):  
Sara Emamgholipour ◽  
Lotfali Agheli
Keyword(s):  
Pharmaceutical Industry ◽  
Economies Of Scale ◽  
Monopolistic Competition ◽  
Pharmaceutical Market ◽  
Data Availability ◽  
Market Demand ◽  
Firm Level ◽  
Content Type ◽  
Measure Concentration ◽  
Pharmaceutical Industries

Purpose As the pharmaceutical industry is one of the key sectors of the health-care system, the identification of its structure is of particular importance. This paper aims to determine the structure of the pharmaceutical industry in Iran to provide appropriate solutions for pricing and regulation by policymakers. Iran is a growing pharmaceutical market with over $4bn in sales, so the supply side needs to be examined to meet the domestic consumption. Design/methodology/approach This research is a descriptive and retrospective analytical study which examines the Iranian pharmaceutical industry through library studies and using pharmaceutical data of the country’s Food and Drug Administration during 1992-2016. Due to data availability in firm level, the concentration ratio of N leading firms and the Herfindahl–Hirschman index are used to measure the concentration of the pharmaceutical market in 2014 and 2016. Findings The results show that pharmaceutical manufacturing, importing companies and distributing companies play roles in monopolistic competition market, loose oligopoly market and oligopoly market, respectively. For all companies, the magnitudes of Herfindahl–Hirschman indices indicate non-competitive settings. As a result, these companies set their own prices, and market demand affects their sales. In addition, demand for medicines is shaped in the form of supply-induced demand. Research limitations/implications This research was accomplished with no computational limitation. However, it was confined to only one country, one industry and the mentioned period of study. Practical implications The pharmaceutical manufacturers have no influence on medicine prices, and government pricing regulations lessen the market power of such market agents. However, the easy entry to and exit from market stimulate producers to participate in manufacturing activities. The pharmaceutical importers may expand their imports in response to entry new actors; however, the new entrants weaken the coordination on pricing decisions. Social implications As pharmaceutical distributers act in an oligopoly market, they can collude, reduce competition and lower the welfare of pharmaceutical consumers. In such conditions, high investment requirements and economies of scale may discourage the entry of new firms. Originality/value Although there are various studies on market structure in non-pharmaceutical industries, this study is a new effort to measure concentration in the Iranian pharmaceutical market and to determine its structure.

Immune control of murine coccidiosis: CD4+and CD8+T lymphocytes contribute differentially in resistance to primary and secondary infections

Parasitology ◽  
1992 ◽  
Vol 105 (3) ◽  
pp. 349-354 ◽  
Author(s):  
M. E. Rose ◽  
P. Hesketh ◽  
D. Wakelin
Keyword(s):  
Monoclonal Antibodies ◽  
T Lymphocytes ◽  
Major Part ◽  
Immune Control ◽  
Similar Treatment ◽  
Cd8 T Lymphocytes ◽  
Secondary Infections ◽  
Effect Of Treatment ◽  
Homologous Challenge ◽  
Increased Susceptibility

SUMMARYThe effect of treatment with monoclonal antibodies (Mabs) which deplete CD4+or CD8+T lymphocytes, on infections withEimeriaspp. was examined in NIH mice. Treatment with anti-CD4 Mab increased susceptibility to primary infections withE. vermiformisorE. pragensisand reduced the subsequent resistance of the mice to homologous challenge. Similar treatment of immune mice did not affect their resistance to re-infection but this was reduced in mice depleted of CD8+T lymphocytes. In mice immunized withE. vermiformisthe effect of CD8+-depletion was very slight, apparent only as the presence of small numbers of oocysts in the faeces of some mice; in mice immunized withE. pragensisthere was a small, though significant, increase in oocyst production, compared with controls and anti-CD4-treated groups. These results confirm the importance of mechanisms involving the function of CD4+T lymphocytes in the control of primary infections withEimeriaspp. and indicate that CD8+cells play some part in the expression of resistance to reinfection. They also show that a major part of this resistance was not affected by either of the treatments given.

HERODOTUS BECOMES INTERESTED IN HISTORY

2014 ◽  
Vol 61 (1) ◽  
pp. 1-6
Author(s):  
David Harvey
Keyword(s):  
Major Part ◽  
The Real ◽  
Final Draft ◽  
First Time ◽  
The Temple ◽  
Greek World ◽  
The Way

At 3.60 Herodotus tells us that he has dwelt at length on the Samians because ‘they are responsible for three of the greatest buildings in the Greek world’: the tunnel of Eupalinos, the great temple, and the breakwater that protects their harbour. As successive commentators have pointed out, that is not the real reason for the length of his account. We hear about the tunnel for the first time in this chapter (60.1–3); Maiandrios escapes down a secret channel at 146.2, which may or may not be Eupalinos' tunnel; we hear about the temple of Artemis, not of Hera, at Samos in 48; dedications in the temple of Hera are mentioned in passing at 1.70.3, 3.123.1, 4.88.1, and 4.152.4, but the temple itself cannot be said to play a major part in Herodotus' narrative; naval expeditions sail from Samos (e.g. 44.2, 59.4) but there is no emphasis on the harbour or its breakwater. What Herodotus should have said is ‘I have dwelt at length on Samos, because I am interested in the island's history; and, by the way, they are responsible for three…’; but it is not our job to tell him what he ‘should’ have said. As David Asheri remarks, ‘We can explain it [the length of the Samian logos] most simply by supposing that the logos already existed before the final draft of the book’.

Chronic Cannabis Users: A New Special Population to Consider for Drug Development

2021 ◽  
Vol 16 ◽  
Author(s):  
Gina Pastino ◽  
Diana Shuster
Keyword(s):  
Clinical Pharmacology ◽  
Drug Development ◽  
Cannabis User ◽  
Special Population ◽  
Safety And Efficacy ◽  
New Drug ◽  
Metabolic Interactions ◽  
Widespread Availability ◽  
Baseline Characteristics ◽  
Efficacy Profile

The use and acceptance of cannabis, either medically or recreationally, has substantially outpaced the collection of data necessary to evaluate its use in any population. However, the mere widespread availability does not imply the absence of risk or confirmation of efficacy and should not be treated as such. There is enough data to suggest that not only does the potential for pharmacokinetic and metabolic interactions exist, but also that baseline characteristics for a given population could be different in chronic cannabis users. Either or both of these may impact the safety and efficacy profile for any new drug in development. As such, we encourage drug developers to consider that the cannabis user may very well be a special population that warrants its own clinical pharmacology evaluation.

Overview of recently approved 505(b)(2) new drug applications (2010-2012): Role of clinical pharmacology

2014 ◽  
Vol 54 (12) ◽  
pp. 1330-1336 ◽  
Author(s):  
Sheetal Agarwal ◽  
Wei Qiu ◽  
Chandrahas Sahajwalla
Keyword(s):  
Clinical Pharmacology ◽  
New Drug
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