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Much of the public interest in pharmaceutical Research & Development concerns the relationship between drug prices, the cost of drugs of the companies, and the pace and direction of innovation. Average prices of new drug products have been rising much faster than the rate of inflation and annual R&D spending has grown faster still. Nevertheless introductions of innovative new drugs have slowed. At the same time, drug companies have been able to charge high retail prices for new drugs that are only incrementally different from older drugs whose prices have fallen. With consumers paying more for new drugs in the United States than almost anywhere else in the world and with the perception that the drug industry has become less innovative many observers have wondered whether some kind of policy intervention is warranted in controlling pharmaceutical research and development.
To make drugs serve their purpose various chemical and instrumental methods are developed at regular intervals which are involved in the estimation of drugs. These pharmaceuticals may develop impurities at various stages of their development, transportation and storage which makes the pharmaceutical risky to be administered thus they must be detected and quantified. For this analytical instrumentation and methods play an important role. The study and research highlights the role of the analytical instrumentation and the analytical methods in assessing the quality of the drugs. It analyses a variety of analytical techniques such as titrimetric, chromatographic, spectroscopic, electrophoretic, and electrochemical and their corresponding methods that have been applied in the analysis of pharmaceuticals.
From the Academic and Industry Perspective pharmaceutical formulations in pharmaceutics are the process in which different chemical substances, including the active drugs are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form. Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally administered drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to make the distinction that a tablet contains a variety of other potentially inert substances apart from the drug itself, and studies have to be carried out to ensure that the encapsulated drug is compatible with these other substances in a way that does not cause harm, whether direct or indirect.
Pharmaceutical Nanotechnology deals with the study that provides insights into the synthesis, characterisation and pharmaceutical or diagnostic application of materials at the nanoscale. The nanoscale is defined as a size range of below 1m. Scientific findings related to micro and macro systems with functionality residing within the features defined at the nanoscale. The study includes detailing the synthesis, exhaustive characterization, biological evaluation; clinical testing and or toxicological assessment of nanomaterials are of particular interest to the journals readership. Articles should be self contained, centered on a well founded hypothesis and should aim to showcase the pharmaceutical / diagnostic implications of the nanotechnology approach.
Pharmaceutical IPR and Regulatory Affairs impact economic growth and competitiveness. A developed drug needs to be protected either by getting it patented or under trade secret. The problem with trade secret is that it the drug can be reverse-engineered and hence your invention can be stolen; whereas patent provides a much more water tight protection. IPR is very important for economic growth of a company. Awarding sole rights to the inventor gives him the privilege of reaping the profits without any division. The marketing rights over the product are solely the inventors and he can sell it or license it. The company can earn a lot and reinvest it. Investing in research and development is very important for a company as it has to stay in the forefront. IPR gives you the right encouragement to do it. There is a need for developing new drugs and vaccines as there are new diseases being discovered daily or there is resistance development by the pathogen.
Pharmacodynamics is the study of the biochemical and physiologic effects of drugs, especially pharmaceutical drugs. The effects include those manifested within animals including humans, microorganisms, or combinations of organisms for example, infection. Pharmacodynamics is the study of how a drug affects an organism, whereas pharmacokinetics is the study of how the organism affects the drug. Both influence dosing, benefit, and adverse effects. Pharmacodynamics is sometimes abbreviated as PD and pharmacokinetics as PK, especially in combined reference when speaking of PK/PD models. Pharmacodynamics places particular emphasis on dose–response relationships, that is, the relationships between drug concentration and effect.
Pharmacokinetics, abbreviated as PK, is a branch of pharmacology dedicated to determining the fate of substances administered to a living organism. The substances of interest include any chemical xenobiotic such as pharmaceutical drugs, pesticides, food additives, cosmetics, etc. It attempts to analyze chemical metabolism and to discover the fate of a chemical from the moment that it is administered up to the point at which it is completely eliminated from the body. Pharmacokinetics is the study of how an organism affects a drug, whereas pharmacodynamics (PD) is the study of how the drug affects the organism. Both together influence dosing, benefit, and adverse effects, as seen in PK/PD models.
Pharmacogenomics is the study of the role of the genome in drug response. It reflects the combining of pharmacology and genomics. Pharmacogenomics analyzes how the genetic makeup of an individual affects his response to drugs. It deals with the influence of acquired and inherited genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with pharmacokinetics drug absorption, distribution, metabolism, and elimination and pharmacodynamics effects mediated through a drug's biological targets. The term pharmacogenomics is often used interchangeably with pharmacogenetics. Pharmacogenetics focuses on single drug-gene interactions while pharmacogenomics encompasses a more genome-wide association approach, incorporating genomics and epigenetics while dealing with the effects of multiple genes on drug response.
Pharmaceutical drug delivery technologies enhance drug absorption, efficacy, and patient experience. Bioavailability of medications within the system can be achieved by increasing the dissolution rate with specialized drug delivery enhancement products. Enhancing the drug delivery technology of your final pharmaceutical formulation can increase its commercial success. A host of new delivery platforms is in development some of which have recently reached the market. The primary goal of these developments is to create systems that optimize a drug's therapeutic value. Additionally, it is estimated that up to 50 percent of new drugs cannot be taken orally, so the impetus to create innovative delivery platforms is strong and growing.
Drug Metabolism and Disposition is concerned with the fields of pharmacology and toxicology. It studies in vitro and in vivo studies of the metabolism, transport, and disposition of drugs and environmental chemicals, including the expression of drug-metabolizing enzymes and their regulation. Drug metabolism is the metabolic breakdown of drugs by living organisms, usually through specialized enzymatic systems. More generally, xenobiotic metabolism is the set of metabolic pathways that modify the chemical structure of xenobiotics, which are compounds foreign to an organism's normal biochemistry, such as any drug or poison. These pathways are a form of biotransformation present in all major groups of organisms, and are considered to be of ancient origin.
Toxicity refers to how poisonous or harmful a substance can be. In the context of pharmacology, drug toxicity occurs when a person has accumulated too much of a drug in his bloodstream leading to adverse effects on the body. Drug toxicity may occur when the dose given is too high or the liver or kidneys are unable to remove the drug from the bloodstream allowing it to accumulate in the body; and as a result of over-ingestion of a medication having too much of a drug in a person's system at once. However, with certain medications, drug toxicity can also occur as an adverse drug reaction (ADR). In this case the normally given therapeutic dose of the drug can cause unintentional, harmful and unwanted side effects.
Vaccines are the preparations given to patients to evoke immune responses leading to the production of antibodies humoral or cell-mediated responses that will combat infectious agents or noninfectious conditions such as malignancies. Alarming safety profile of live vaccines, weak immunogenicity of sub-unit vaccines and immunization, failure due to poor patient compliance to booster doses which should potentiate prime doses are few strong reasons, which necessitated the development of new generation of prophylactic and therapeutic vaccines to promote effective immunization. Attempts are being made to deliver vaccines through carriers as they control the spatial and temporal presentation of antigens to immune system thus leading to their sustained release and targeting.
Increased demand for biopharmaceutical companies to identify new drugs and to uncover novel therapeutic targets has meant a greater interest in exploring the therapeutic potential of less abundant cellular proteins. Analytical scientists have their work cut out for them. Multitudes of new, non-platform formats are landing in their labs, requiring them to develop robust methods to characterize these molecules from which to identify the desired properties and target product profiles. Biotherapeutics aims to arm scientists with the tools and knowledge to speed innovation by showcasing novel technologies, proven techniques or risk-based approaches that can help characterize the new modalities, analyze the structure-function and determine CQAs of the molecules. Its ability to scrutinize physical and chemical protein stability as well as the pharmacokinetic properties of a protein makes it a practical, flexible tool for use during biopharmaceutical development.
While the peptide and protein therapeutic market has developed significantly in the past decades, delivery has limited their use. Although oral delivery is preferred, most are currently delivered intravenously or subcutaneously due to degradation and limited absorption in the gastrointestinal tract. Therefore absorption enhancers, enzyme inhibitors, carrier systems and stability enhancers are being studied to facilitate oral peptide delivery. Additionally, transdermal peptide delivery avoids the issues of the gastrointestinal tract, but also faces absorption limitations. Due to proteases, opsonization and agglutination, free peptides are not systemically stable without modifications. It further studies oral and transdermal peptide drug delivery focusing on barriers and solutions to absorption and stability issues. Methods to increase systemic stability and site-specific delivery are also studied.
The research covers the major aspects relating to the use of novel delivery systems in enhancing both transdermal and intradermal drug delivery systems. It further studies the history of the field and the various methods employed to produce delivery systems from different materials such as device design, construction and evaluation, so as to provide a sound background to the use of novel systems in enhanced delivery applications. Furthermore, it presents in-depth analyses of recent developments in this exponentially growing field with a focus on microneedle arrays, needle-free injections, nanoparticulate systems and peptide-carrier-type systems. It also covers conventional physical enhancement strategies such as tape-stripping, sonophoresis, iontophoresis, electroporation and thermal/suction/laser ablation. Comprehensive and critical reviews of transdermal and intradermal delivery research using such systems focus on the outcomes of in vivoanimal and human studies.
Novel Drug Delivery System (NDDS) refers to the approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects. NDDS is a system for delivery of drug other than conventional drug delivery system. NDDS is a combination of advance technique and new dosage forms which are far better than conventional dosage forms. Advantages of Novel Drug Delivery System are optimum dose at the right time and right location, efficient use of expensive drugs, excipients and reduction in production cost, beneficial to patients, better therapy, improved comfort and standard of living. Basic modes of novel drug delivery systems are targeted drug delivery system, controlled drug delivery system and modulated drug delivery system factors affecting the design of controlled release products.
Most conventional drug delivery systems are not acceptable for pediatric patients as they differ in their developmental status and dosing requirements from other subsets of the population. Technology platforms are required to aid the development of age-appropriate medicines to maximize patient acceptability while maintaining safety, efficacy, accessibility and affordability. Pediatric patients require different oral drug delivery systems than other subsets of the population due to their continuing development hence dosing and administration requirements. Conventional formulations are not designed for this patient group. Thus, manipulation and compounding has become common practice. Age-appropriate oral drug delivery systems specifically developed to meet the needs of the pediatric population are therefore desired. In terms of adherence and concordance geriatric patients would also benefit from patient-centric formulation design tailored to overcome the impaired physiological, visual, motoric functions and swallowing capabilities.
Implantable drug-delivery systems are being developed to release drugs to the bloodstream continuously as well as free patients from being hospitalized to receive intravenous infusions or frequent injections. One technique is implantation of a pellet in the subcutaneous tissue so the pellet may be released by erosion. Drugs are also diffused through silicone rubber capsules but only polyacrylamide is able to release large molecules. Contraceptive rings containing progesterone and placed in the uterus or vagina and implanted silicone-rubber capsules use these principles. Disadvantages to the subcutaneous delivery of drugs include release of the drug in subcutaneous tissue rather than in the bloodstream directly; entry into the circulatory system is controlled by surrounding blood supplies which vary with fat; diffusion may be difficult due to dense layers of fibrous tissue; and drug amounts cannot be readily regulated.
Four possible regulatory situations for delivery system and drug have been identified and generalizations regarding the non-clinical studies needed for the initiation of clinical trials and New Drug Application (NDA) have been described. Problems associated with the identification of appropriate controls have been included and the importance of basing the choice upon a scientifically rational evaluation of the pharmacodynamic and pharmacokinetic study results emphasized along with the significance of conducting the non-clinical evaluation using the final formulation.The lure of optimizing the effect of the drug on the body pharmacodynamics and the body on the drug pharmacokinetics has produced an alternative group of products designed to achieve specialized delivery and or disposition of drugs.
Major Challenges in Drug Delivery have the potential to address many chronic diseases and various unmet medical needs. The number of biologic drugs in development has seen the exponential growth with more than 2,700 remedies in development as of mid-2017 triple the 900 in development in 2013. The largest growth is occurring in the therapeutic areas of cancer and cancer related conditions, rare diseases and neurologic disorders. In addition, increasing emphasis has been placed on developing biologics to treat autoimmune disorders. All signs indicate that the trend for increased development, approval, and use of biologics will continue into the foreseeable future. The success of these biologic drugs reflects their ability to treat certain cancers and the other diseases they target better than existing drugs and with fewer side effects. This, combined with an aging population that will be more susceptible to such diseases, is driving the growth of the global biological drugs market according to Transparency Market Research.
Clinical and Medical Case Reports aims to provide a platform for publishing unusual, unique, and rare clinical cases and images to enhance the clinical understanding of disease and to convey important clinical information. These case reports consider the studies of original case reports, case studies, case series, clinical images, clinical videos, and letters from all the areas of clinical medicine to create a valuable collection of cases in all clinical disciplines. This is a case of a 37-year-old, right-hand dominant, Malay man who fell approximately 6 meters from a rambutan tree and his left arm hit the tree trunk on his way down. He was an active smoker with a 20 pack of cigars per year smoking history. On clinical examination Doppler signals over his radial and ulnar arteries were poor. He proceeded with emergency computed tomography angiogram of his left upper limb which showed non-opacification of contrast at the distal left brachial artery just before the bifurcation of the left brachial artery at his left elbow joint.