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Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design. There are many chemicals with pharmacological properties, but need special measures to help them achieve therapeutically relevant amounts at their sites of action. Pharmaceutics deals with the formulation of a pure drug substance into a dosage form
The pharmaceutical sciences combine a broad range of scientific disciplines that are critical to the discovery and development of new drugs and therapies. Pharmaceutical sciences can be broadly classified into the following main categories, with many specialized fields within each category.
Biopharmaceuticals are medical drugs produced using biotechnology. They are proteins (including antibodies) nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native biological source. The large majority of biopharmaceutical products are pharmaceuticals that are derived from life forms. Small molecule drugs are not typically regarded as biopharmaceutical in nature by the industry. However members of the press and the business and financial community often extend the definition to include pharmaceuticals not created through biotechnology.
Radiopharmaceutical is a drug that can be used either for diagnostic or therapeutic purposes. It is composed of a radioisotope bond to an organic molecule. The organic molecule conveys the radioisotope to specific organs, tissues or cells. The radioisotope is selected for its properties. Radioisotopes emitting penetrating gamma rays are used for diagnostic (imaging) where the radiation has to escape the body before being detected by a specific device. Typically, the radiation emitted by isotope used for imaging vanishes completely after 1 day through radioactive decay and normal body excretion.
Pharmaceuticals technology focuses on transforming small molecules, proteins, and genes into therapeutic products. These include new drug therapies, drug design, molecular modeling, high throughput screen, production and stability considerations, and delivery systems of protein and gene therapeutics.
- Biotechnological Aspects Of Product Development: concepts and techniques.
- Development of recovery processes for recombinant proteins and peptides
- Resealed erythrocytes as drug carriers
- Supramolecular drug delivery
- Engineered commensal bacteria as a novel drug delivery system
- Delivery of peptide and protein drugs
Tract 05: Innovation in Drug Discovery Technology
Technology has been a major driver of advances in drug discovery. Automation, nanofluidics, imaging, software and assay technologies have played a major role in getting better data, faster. Is drug discovery at such an advanced state that further improvements are no longer needed or cost-effective? There are different opinions on this and much of the evidence is anecdotal, but technology innovation is critical to the improvement of the drug discovery process and worth discussing. Over the course of a year I attend 4 or 5 drug discovery conferences in the US and Europe. This gives me a good opportunity to visit exhibits, attend presentations and read posters
Computational chemistry is one of the technique it uses physics-based algorithms and the computers to simulate chemical events and calculate the chemical properties of the atoms and molecules. In the drug design and discovery, the diverse computational chemistry approaches are used to calculate and predict the events, such as the drug binding to its target and the chemical properties for the designing potential of new drugs.
Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.
Nanotechnology is the study, design, creation, synthesis, manipulation, and application of materials, devices, and systems at the nanometer scale. Nano medicine is the branch of medicine that utilizes the science of nanotechnology in the preclusion and cure of various diseases using the nanoscale materials, such as biocompatible nanoparticles and nanorobots for various applications including, diagnosis, delivery, sensory, or actuation purposes in a living organism. Drugs with very low solubility possess various biopharmaceutical delivery issues including limited bio accessibility after intake through mouth, less diffusion capacity into the outer membrane; require more quantity for intravenous intake and unwanted after-effects preceding traditional formulated vaccination process. However all these limitations could be overcome by the application of nanotechnology approaches in the drug delivery mechanisms.
Biomarkers of disease play an important role in medicine and have begun to assume a greater role in drug discovery and development. The challenge for biomarkers is to allow earlier, more robust drug safety and efficacy measurements. Their role in drug development will continue to grow for the foreseeable future. For biomarkers to assume their rightful role, greater understanding of the mechanism of disease progression and therapeutic intervention is needed. In addition, greater understanding of the requirements for biomarker selection and validation, biomarker assay method validation and application, and clinical endpoint validation and application is needed. Biomarkers need to be taken into account while the therapeutic target is still being identified and the concept is being formulated. Biomarkers need to be incorporated into a continuous cycle that takes what is learned from the discovery and development of one series of biomarkers and translates it into the next series of biomarkers.
Pharmacogenomics 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 and pharmacodynamics. Pharmacogenomics aims to develop rational means to optimize drug therapy, with respect to the patients' genotype, to ensure maximum efficiency with minimal adverse effects. Through the utilization of pharmacogenomics, it is hoped that pharmaceutical drug treatments can deviate from what is dubbed as the "one-dose-fits-all" approach. Pharmacogenomics also attempts to eliminate the trial-and-error method of prescribing, allowing physicians to take into consideration their patient's genes, the functionality of these genes, and how this may affect the efficacy of the patient's current or future treatments.
Pharmaceutical research and development spending while they are expected to grow at a compounded annual growth rate (CAGR) of 2.8% through 2022, experts and stakeholders are seeing a downward trend in its return on investment (ROI). Pharmaceutical companies are under increasing pressure to either improve the success rates of their research and development or reduce their cost of failure, which a breakthrough typically would cover. The pharma research and development process yields an average success rate of 4.9% from first toxicity dose to market approval. However, experts are questioning whether drug approvals had already reached its peak in 2015 and will continue to decline following the lower number FDA-approved drugs in 2016. With a bleak outlook on improving success rates for pharma research and development , more and more pharmaceutical companies are reducing their costs of failures through collaboration.
Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose and treat illness. Clinical research describes many different elements of scientific investigation. Simply put, it involves human participants and helps translate basic research (done in labs) into new treatments and information to benefit patients. Clinical trials as well as research in epidemiology, physiology and pathophysiology, health services, education, outcomes and mental health can all fall under the Clinical research umbrella.
Clinical trial is a type of Clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective. Clinical trial are part of a long, careful process which may take many years to complete. First, doctors study a new treatment in the lab.
In the context of medical devices, a clinical trial or a clinical investigation can be defined as any systematic investigation or study on one or more human subjects undertaken to assess the safety or performance Different types of Clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research. Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.
Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.
Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition. Screening Research aims to find the best ways to detect certain disorders or health conditions.
Microbiology research is far less regular than understudy endeavors in the other significant regions of science. This is incompletely because of the simplicity, in view of size, with which the "large scale" territories have frameworks to work with; therefore extends are effectively conceptualized and performed utilizing natural abilities including the noticeable world. For the most part one timetables an assortment of customary classroom lab practices in the "full scale" disciplines which require no significant bits of gear nor extensive amounts of various materials; at that point understudies regularly utilize these labs to create thoughts for inquire about activities suited to their loving .
The science of clinical trials in oncology evolved to include phase I dose‐finding trials, phase II studies to establish efficacy in a single tumor type, phase III trials comparing standards of care with potential advances in care, and phase IV studies to extend safety and activity data in a post‐marketing scenario. As a consequence, we can expect higher cure rates in locally confined cancers and in some metastatic cancers. Investigators have substantially extended median overall survival statistics for trial subjects and patients treated off of trials who have had advanced stages of malignant diseases. An example of this extension of median overall survival in the setting of advanced, incurable disease comes from patients treated on clinical trials for advanced colorectal cancer.
Gene therapy is a novel therapeutic branch of modern medicine. Its emergence is a direct consequence of the revolution heralded by the introduction of recombinant DNA methodology in the 1970s. Gene therapy is still highly experimental, but has the potential to become an important treatment regimen. In principle, it allows the transfer of genetic information into patient tissues and organs. Consequently, diseased genes can be eliminated or their normal functions rescued. Furthermore, the procedure allows the addition of new functions to cells, such as the production of immune system mediator proteins that help to combat cancer and other diseases.