Bioavailability can be referred to as the rate and extent to which active ingredient or active element of the drug product is absorbed and becomes available at the site of action. The extent and rate of drug absorption are usually measured by the area under the blood or plasma concentration-time curve (AUC) and the maximum concentration (Cmax), respectively. For drug products that are not planned to be absorbed into bloodstream, their bioavailability may be assessed by measurements intended to reflect the rate and extent to which the active moiety of the drug product is absorbed and becomes available at the site of action.
Bioequivalence: When two drug products or two formulations of the same drug provide the same therapeutic effect, they are said to be bioequivalent, or, that they are therapeutically equivalent. It means, their rates and extent of absorptions do not reflect a significant difference at the site of action.
Session 2: Biotherapeutics
It encompasses the synthesis and production of therapeutic materials using biological means, including recombinant DNA technology. These therapeutic materials or active substances are extracted or produced from a biological source. These include monoclonal antibodies, recombinant proteins and hormones, vaccines, cell-based products, cytokines, growth factors, stem-cell therapies, tissue-engineered products, gene-therapy products.
Session 3: Case Reports
Case reports can be defined as the scientific documentation of an individual patient. These reports are prepared to document atypical clinical outcome, treatment regimen, adverse report, or response to treatment. These are the detailed presentation of the symptoms, signs, diagnosis, treatment, and follow up of the patient. It can be assumed as the first line of evidence in healthcare and can lead to top-level research in future. They can be shared for medical, scientific, or educational purposes. Case reports are narratives that provide a framework for unusual outcome of a certain treatment.
Clinical trials or clinical research are prospective experiments or behavioural research studies that involve human participants to determine safety and effectiveness of new treatments or, existing treatments. These can be observational study or interventional approach. In clinical research involving observational study, the investigators observe the subjects and measure their clinical outcomes. While, in interventional study, the investigators compare the treated subject with those receiving no standard treatment or, no treatment. Clinical trials are conducted in four phases, with ease phase having a different number of human participants and specific purpose.
Drug discovery and development process can be collected defined as the process of identifying potential active ingredients from natural products or extracts and optimization of these substances from various methods to bring a new pharmaceutical drug to the market.
Drug formulation is the process of combining various chemical substances to produce a final medicinal product, the final product is called a drug mixture or drug formulation. This process takes various factors into consideration such as solubility, particle size, polymorphism and pH. These all factors influence bioavailability and therapeutic effect of a drug.
Drug manufacturing is the process of production of drug products at large scale involving pharmaceutical companies. The whole drug manufacturing procedure is the specific processes of several unit operations including formulation and pre-formulation development of drug products.
Session 7: Ethics in Pharmaceutical Sciences
In pharmaceutical science, certain ethical principles are composed to ensure the patient’s integrity and safety that must be followed by individual involving in pharmaceutical industry. These may include autonomy, justice, beneficence, and non-maleficence. Pharmacy practice is vulnerable to ethical challenges associated with pharmaceutical care, relationship with patient’s cooperation with the healthcare team that needs special code of conducts These codes of conducts include professional code of ethics for pharmacists and ethics guidelines for pharmaceutical importers, pharmaceutical companies, distributors and policy makers.
Session 8: Impact of Technology in Pharma Sciences
Healthcare information technology is the area of information technology system involving the design, development, creation, use and maintenance of information system approaches to improve public health, medical care, lower cost, increase efficiency, reduce errors and improve patient satisfaction for the healthcare industry. These include uses of data analytics, artificial intelligence, cognitive computing and many others to effectively manage patient health management programs, development of new therapies and drugs, efficient aggregation and analysis of patient information.
Session 9: Medicinal Chemistry
Medicinal Chemistry is the branch of science that link may scientific disciples with a common goal of researching and developing new drugs. It involves the application of knowledge in synthesizing and developing new therapeutics. Medicinal Chemists are concerns with the Isolation of medicinal agents found in plants and collaborate scientists from different disciplines such as Biologists, Pharmacologists, theoretical chemists, Toxicologists, microbiologists and theoretical chemists to synthesize and develop new drugs in environment-friendly and cost-effective way.
Session 10: Nanomedicine
Nanomedicine is the branch of medicine that applies the principles and tools of nanotechnology for prevention and treatment of disease. It may involve the use of nanoscale materials for diagnosis, delivery, sensing or actuation purposes in a living organism. These nanoscale materials include biocompatible nanoparticles, nanorobots, nano-electronic sensors, biological devices and others.
Session 11: Pharmacoeconomics
Pharmacoeconomics centres on the evaluation of Pharmaceuticals, and uses cost-benefit analysis, cost-minimization analysis, cost-effectiveness analysis or cost-utility analysis. It is a sub-disciple of health economics and helps in optimal healthcare resource allocation, in a standardized and scientifically grounded manner.
Session 12: Pharmacoepidemiology
Pharmacoepidemiology is that the study of applied medication and effects in massive numbers of people. It provides an estimate of the beneficial drug effect and an estimate of adverse drug effect in a population. It is said to be a combination of Clinical Pharmacology and Epidemiology. It entirely deals with the calculation on Genetic Variation of drug effect, duration-response relationships, clinical effects of drug-drug interactions, and the effects of medication non-adherence.
Session 13: Pharmacogenomics
Pharmacogenomics is the study of effect of genetic makeup of an organism towards his response to drugs. It combines pharmacology and genomics to develop effective, safe medications and doses that will be tailored to a person’s genetic makeup. It deals with the influence of acquired and inherited genetic variation on drug response in patients by correlating gene expression with pharmacokinetics and pharmacodynamics.
Session 14: Pharmacognosy
Pharmacognosy can be defined as the study of medicines or drug products obtained from natural sources such as plants, animals and microbes. It also includes the analysis of their biological, biochemical, and physical properties. Specifically, this branch encompasses of study of secondary metabolites, such as tannins, terpenoids, glycosides, alkaloids as well as medicines from marine and terrestrial and microbes and animals.
Pharmacokinetics is defined as the process of uptake of drugs by the body and the biotransformation, distribution of drugs and their metabolites from the body over a time period. It tells us about how a drug is being affected by the organism intake. Pharmacodynamics on the other side tells us how a drug affects the organism. The effects can include those manifested within humans, animals, microorganisms, or combinations of organisms.
Session 16: Pharmacology
Pharmacology is the branch of science dealing with the origin, composition, pharmacokinetic, therapeutic use and toxicology of drugs. It also encompasses the properties, interactions, therapy, medical applications and antipathogenic capabilities of the drugs or drug substances.
Pharmacovigilance or drug safety is the branch of pharmaceutical science which deals with the detection, assessment, understanding and prevention of side effects or adverse effects associated with the drugs. It specifically focuses on adverse drug reactions, which can be defined as the unusual or intended response to a drug.
Session 18: Pharmacy Management
Pharmacy management system includes the safe and effective dispensing of pharmaceutical drugs. It includes usage of stock management and billing and accounting. It is used primarily by the pharmacy section in a healthcare facility. It enables a healthcare facility to effectively dispense medications to patients and manage stock and suppliers and in billing and accounting for drugs and services.
Regulatory affairs in pharma industry is the area which involves compliance of regulatory principles regarding quality, safety and efficacy of drugs. It involves development plans, supervising, reviewing and assembling and submission management. Regulation involves extensive evaluation of a particular drug or drug product to ensure protection of patient, registration of drug, marketing authorization, import and distribution and pharmacovigilance.
Session 20: Toxicology
Toxicology is the scientific study involving the adverse reactions in response to a particular treatment or drug. It involves observing and reporting symptoms, mechanisms, detection and treatments of toxic substances, in relation to the poisoning of humans. It includes environmental agents and chemical compounds found in nature, as well as pharmaceutical compounds that are synthesized for medical use by humans. These substances may produce toxic effects in living organisms including disturbance in growth patterns, discomfort, disease and death.
Market Analysis of Global Pharmaceutical Industries:
The global $1.12 trillion markets in 2022, will rise at a faster clip during 2016-2020, then slow down a bit as major patent expiration take hold. It is expected that the global market declined by 1.0% in 2015 but will grow by 4.8% this year. Prescription sales excluding generics will rise 4.4% this year and expected to reach $1.006 trillion in 2022. Generics sales will increase from $73 billion in 2015 to $115 billion in 2022 and constitute 10.2% of prescription sales at that point only 0.3 percentage points more than it is now.
The global market for drug discovery technologies and products was worth $38.4 billion in 2011. This figure is projected to reach $41.4 billion in 2012 and $79 billion in 2017, a five-year compound annual growth rate (CAGR) of 13.8%. There is a need to impede serious adverse effects caused by the drugs by enhancing drug targeting through research in pharmacology.
The global revenue for single use technology reached $1.4 billion and $1.7 billion in 2013 and 2014, respectively. This market is expected to grow at a compound annual growth rate (CAGR) of 11.7% to nearly $3.0 billion for the period 2014-2019.
The fast-growing division of the pharmaceutical market includes generics and biologics. Biologics now account for over a third of all new drugs in clinical trials or awaiting FDA approval.15 U.S generic drug sales reached an estimated $70 billion, representing a quarter of the global market, due to a large number of drugs going off-patent and healthcare reforms favoring generics. Although generics make up only 22 percent of total prescription sales, its share of filled prescriptions has risen from 19 percent in 1984 to 88 percent in 2015. The research-based pharmaceutical industry is estimated to have spent nearly USD 149.8 billion globally on pharmaceutical R&D in 2015-16. Among all the industrial sectors, the research-based pharmaceutical industry has consistently invested the most in research and development, even in times of economic turmoil and monetary crisis.
According to the Quintiles IMS Institute predicts that the pharmaceutical market by 2021 will reach nearly USD 1,485 billion, by an increase of USD 350-380 billion from the USD 1,105 billion recorded in 2016. Global brand spending is forecast to increase to USD 815-832 billion in 2021. Global generic spending is expected to increase to USD 495-505 billion by 2021.
The United States share of global spending will increase from USD 461.7 billion in 2016 to USD 645-675 billion in 2021, while the European share of spending will grow from USD 151.8 billion to USD 170-200 billion. Meanwhile, pharmerging countries will spend nearly 315-345 USD billion in 2021 from 242.9 in 2016.
Major Pharma Associations around the Globe:
- International Pharmaceutical Federation (FIP)
- International Pharmaceutical Students' Federation (IPSF)
- European Association of Employed Community Pharmacists in Europe (EPhEU)
- Pharmaceutical Group of the European Union (PGEU)
- National Pharmacy Association
- Pharmaceutical Society of Northern Ireland