10^th Annual Congress on Drug Formulation & Analytical Techniques December 10-11, 2018 Dubai, UAE

Pharmaceutical formulation in pharmaceutics is the process in which various chemical substances including the vigorous drug are joined to produce a final medicinal product. Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually contains combining the drug into a tablet or a capsule. Formulations confirm that the drug is compatible with these other substances. In the pharmaceutical drug formulations, the different physical, chemical, and mechanical properties of a drug are considered so as to know what other ingredients should be used in the preparation. The various factors like polymorphism, particle size, pH, and solubility are all considered while formulating the drug, also considering the appearance of the tablet.

Clinical trials are the experiments done in clinical research. Clinical research ecosystem involves a complex network of sites, pharmaceutical companies and academic research institutions. Each clinical trial has a plan of action or a protocol for conducting trial. Clinical trials generate data on safety and efficacy. Different types of clinical research include Treatment, Prevention, Diagnostic, Screening, Quality of life, Genetic studies, Epidemiological studies, Phases of clinical trials (when clinical research is used to evaluate medications and devices)

Conducting a Bioavailability study enables assessment of the impact of route of administration on BA and defines the absolute bioavailability of the drug released from the drug product. BA for a given formulation provides an assessment of the relative fraction of the orally administered dose that is absorbed into the systemic circulation. If the reference standard is an IV dose, it is referred as Absolute Bioavailability. If the reference standard is any other dosage form than IV, it is referred as Relative Bioavailability. Micro and Micro nutrients play a vital role in bioavailability

Bioavailability is a subcategory of pharmacological absorption. Bioavailability is generally assessed by finding the area under the plasma concentration–time curve. The factors affecting bioavailability are Pharmaceutics factors, physicochemical properties of drug, Dosage form characteristics & Pharmaceutical Ingredients, Patient related factors like age, Routes of administration (Parenteral, Rectal, Oral, and Topical)  etc. Topics under this track includes Nutrient Bioavailability, Absolute Bioavailability, Relative Bioavailability, Mineral Bioavailability- Micro and Macro, Vitamins Bioavailability, BA of Contaminants in Soils & Sediments, Drug Absorption and Distribution, Disposition studies, Drug Formulation and Dosage Forms, Product design- Considerations, Bio accessibility Factor

A contract research organization (CRO) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs also support foundations, research institutions, and universities, in addition to governmental organizations. Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval, without the drug sponsor having to maintain a staff for these services.

The development of biologics  calls for overcoming lot many challenges. With initial steps of concepts of biologics, their considerations, essentials for early clinical developments it is very much needed that proper scientific and strategic approaches are taken for the successful development of follow-on-biologics. Moreover, the need for overcoming the challenges continues in the late clinical steps, drug safety factors and labeling requirements. Also, it is much required now to develop a drug product in accordance to quality by design (QbD). This Drug related conference will look at the multiple facets of current challenges in bio similar development and focuses on multiple aspects of bio similar product development to successfully deliver safe, potential and efficacious biologic products to the market

Pharmaceutical freeze Technology is the removal of ice or other frozen solvents from a material through the process of sublimation and the removal of bound water molecules through the process of desorption. Lyophilization and freeze drying are terms that are used interchangeably depending on the industry and location where the drying is taking place. Controlled freeze drying keeps the product temperature low enough during the process to avoid changes in the dried product appearance and characteristics. It is an first-rate method for preserving a wide diversity of heat-sensitive materials such as proteins, microbes, pharmaceuticals, tissues & Plasma

The aim of bioavailability study is to find out the dosage form influence on the biological performance of the drug, sensitivity to detect differences in the rate and extent of absorption. Bioavailability and bioequivalence study design involves Single dose or multi dose standard 2x 2 crossovers, Parallel groups, for more than two formulations. Study design meant for estimating essential pharmacokinetic parameters differs significantly from a bioequivalence study meant for comparing the test formulation. The results of a pilot study can be used as the sole basis to document BA or BE provided the study’s design and execution are suitable and enough subjects have completed the study

Bioequivalence studies are done for Early and late clinical trial formulations, Formulations used in clinical trial and stability studies, if different Clinical trial formulations and to-be-marketed drug product when it comes to cost and productivity metrics, it’s often said that what gets measured gets done. Bioequivalence is determined based on the bioavailability of the innovator medicine versus the generic medicine. A typical outline for a bioequivalence study includes organization of the test and reference items on two events to volunteer subjects, with every organization isolated by a washout period. This Study involves parameters on (Cmax) and (AUC), Statistical evaluation.

Assessment of the bioequivalence of generic versions of certain reference drugs is complicated by the presence of endogenous levels of said compounds which cannot be distinguished from externally derived compound levels following drug administration. If unaccounted for, the presence of endogenous compound biases towards equivalence in bioequivalence studies of these drugs. Bioequivalence assessments may be complicated further as disposition of the exogenous analogue can be subject to various endogenous processes resulting in nonlinear pharmacokinetics. To overcome these inherent biases a number of different strategies have been employed.

Nanotechnology is the study of extremely small structures, having size of 0.1 to 100 nm. Nano medicine is a relatively new field of science and technology. Brief explanation of various types of pharmaceutical nano systems is given. Classification of nano materials based on their dimensions is given. An application of Nanotechnology in various fields such as health and medicine, electronics, energy and environment, is discussed in detail. Applications of nano particles in drug delivery, protein and peptide delivery, cancer are explained. Applications of various nano systems in cancer therapy such as carbon nano tube, dendrimers, nano crystal, nano wire, nano shells etc. are given. The advancement in nano technology helps in the treatment of neuro degenerative disorders such as Parkinson’s disease and Alzheimer’s disease. Applications of nano technology in tuberculosis treatment, the clinical application of nanotechnology in operative dentistry, in ophthalmology, in surgery, visualization, tissue engineering, antibiotic resistance, immune response are discussed in this article. Nano pharmaceuticals can be used to detect diseases at much earlier stages.

Analytical method development is the process of choosing an accurate assay procedure to determine the composition of a formulation. It is the process of proving that an analytical method is acceptable for use in laboratory to measure the concentration of subsequent samples Analytical methods should be recycled within GMP and GLP environments and must be developed using the protocols and acceptance conditions set out in the ICH guidelines. Analytical method development and validation stand the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It supports in formation of product-specific acceptance criteria and stability of results. Validation should establish that the analytical procedure is suitable for its intended purpose. Design of experiment is a powerful tool for the method characterization and validation. 

Chromatography and mass qualitative analysis is employed for analysis of organic compounds. Electro spray ionization (ESI) could be a method employed in mass spectroscopic analysis. As relate to chromatography and mass spectrometry. HPLC is further flexible informative and trusted by the industry people. Recent advances in sample preparation techniques to beat difficulties encountered throughout measuring of little molecules from bio fluids mistreatment LC-MS. For Measuring, observation and protective your important Investments analytical chemistry instruments are used. Global Bio analysis seminars are conducted and those specifically applied for chromatography assays, ligand binding assays to know more advances.

Analytical chemistry is that the study of the separation, identification, quality control and quality assurance of the chemical parts of natural and artificial materials .The maintenance of a desired level of quality in an exceptionally package or product, particularly by resources that of attention to every one stage of the method of delivery or production. Bio analytical Chemistry could be a sub-division of Analytical Chemistry that refuges the measuring of medicine, Ion sensors, Proteins and DNA Sequences in unnatural samples or concentrations. Accurate quantification of the drug samples is extremely very important for several scientific endeavors which cannot delay the result. Therefore the Bio analytical Techniques are in the main focused to bring the correct results of the drug sample to supply an ideal result.

Our research instruments are designed to assist you in finding highly valuable and rare biological variants among vast cell populations. By increasing speed and reducing cost, our Pico droplet technology can help you save resources whilst boosting your chances of success. Our industrial instruments, our research instruments are semi-automated rather than fully automated. While this means they require slightly more user input to configure, it also means that they are more flexible and can be easily adapted to fit the needs of your unique research project.

Pharmaceutical science is a major field. It involves different areas of science, which are used to bring out pharmaceutical drug compounds. Computational chemistry involved with the design of new chemical compounds as drugs. Pharmaceutical chemistry and Organic chemistry are involved in the preparation of pharmaceutical drugs. Analytical chemistry involves the quality control and analysis of the pharmaceuticals. Pharmaceutics address the problems in making drug formulations like capsules, tablets, injections etc. The area of pharmacology deals with the study of the efficacy and toxicities of newly designed pharmaceutical compounds.

Industrial Pharmacy also  plays a crucial role in any drug discovery. To any novel drug discovery the industrial approach is very important to get massive commercial application. Few things which have to be considered by industries to provide a safe and cost affective medicine to the patients like Supply chain, Waste management, Product management, Post- marketing surveillance, Good manufacturing practices and Marketing.

The U.S. pharmaceutical market is the world’s most important national market. Together with Canada and Mexico, it represents the largest continental Pharma market worldwide. The United States alone holds some 40 percent of the global pharmaceutical market. In 2014, this share was valued around 365 million U.S. dollars. Many of the global top companies are located in the United States. In 2014, six out of the top eleven companies were U.S.-based.

In bioscience and drugs, to a small grade molecule may be a coffee mass (<900 Daltons [1]) compound which is incapable to facilitate regulate a process, with a size on the order of 10−9 m. Most drug analysis square measure identical little molecules. For analysis of small organic molecules the subsequent devices ought to be recycled are as follows HPLC method, chromatography, Ultraviolet-visible (UV-VIS) spectrophotometry, Infrared (IR) spectrometry and mass spectrometry.

Regulatory affairs (RA), is also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods)

 Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas: Ensuring that their companies comply with all of the regulations and laws pertaining to their business, Working with federal, state and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency(pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission(banking), Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.