7^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit August 29-31, 2016 Atlanta, Georgia, USA

Clinical trials are used to evaluate potential treatments that have had some effect against disease in the lab, or in animal experiments. The whole point of a clinical trial is to find out if a treatment is effective.

The aim of clinical trials is to determine if a treatment works and is safe. By comparing similar groups of people taking different treatments for the same disease it is possible to show whether any benefits are due to the treatment. Effective treatments identified in this way may then become standard practice. since the research is experimental, those who take part in early studies may not always benefit. Once a new approach has been proven safe and effective in a clinical trial, it may become standard practice. Standard practice is a currently accepted and widely used approach and would require approval by a government body such as the FDA or EMEA.

An overview of the global market for generic drugs, including coverage of therapeutics such as antibacterials, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs.The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

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.

The global market for CRO in liquid handling equipment will grow from nearly $2.3 billion in 2014 to nearly $3.4 billion in 2019, with a compound annual growth rate (CAGR) of 8.3% for the period of 2014-2019.

Any drug that is taken undergoes a number of chemical reactions in the liver as the body attempts to neutralize foreign substances.  This set of reactions is well characterized, and a great deal of knowledge exists as to how drugs are modified as the body eliminates them.  More importantly, various chemical structures are highly toxic to biological systems, and these are also well characterized.  These constraints must also be taken under consideration as novel drugs are developed.

The global revenue for advanced drug designs is estimated to be $151.3 billion in 2013. In 2018, revenues are estimated to reach nearly $173.8 billion, demonstrating a compound annual growth rate (CAGR) of 2.8%.

Considerable challenges, particularly in the face of further organizational changes slated for OGD. A range of legislative and regulatory actions have facilitated consumer access to safe, high-quality generic products, although manufacturing lapses and product quality problems have created critical shortages in important medicines, casting a shadow over the industry's success.

The global generics sector reached $269.8 billion in 2012. This sector is expected to reach $300.9 billion in 2013 and $518.5 billion in 2018, with a compound annual growth rate (CAGR) of 11.5%.

There are many recent advances and factors affecting  Bio availability. It includes Absorption, metabolism and Food effect of Drugs. Physico-chemical factors, first pass metabolism and Energy dependent efflux transporters are also discussed in BA/BE World Congress.Rate of bioavailability depends on factors such as the type of the substance and the composition of diet.

The global market for sensors was valued at $79.5 billion in 2013 and is expected to increase to $86.3 billion in 2014, $95.3 billion in 2015, and to nearly $154.4 billion by 2020, a compound annual growth rate (CAGR) of 10.1% over the five-year period from 2015 through 2020.                

If two medicines are bioequivalent there is no clinically significant difference in their bioavailability. Although bioequivalence is most commonly discussed in relation to generic medicines, it is important to note that bioequivalence studies are also performed for innovator medicines in some situations.

Global Bioequivalence studies market is projected to increase to nearly $35.3 billion by 2015 from $31.5 billion in 2014. This market is expected to reach $46.8 billion by 2020, corresponding to a compound annual growth rate (CAGR) of 5.8% during 2015 to 2020 period.

This section provides recommendations to the applicants, who undertake bioequivalence studies and/or who wish to request a waiver of in vivo bioequivalence studies for immediate release solid oral dosage forms.  Guidance herein explains how the bioequivalence studies should be performed, and when biowaivers can be requested in the context of the WHO Prequalification of Medicines Programme.

Global BA/BE studies market is projected to increase to nearly $35.3 billion by 2015 from $31.5 billion in 2014. This market is expected to reach $46.8 billion by 2020, corresponding to a compound annual growth rate (CAGR) of 5.8% during 2015 to 2020 period.

In pharmacology, bioavailability is a subcategory of absorption and is the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. 

The overall emerging markets for therapeutic drugs totalled $131.4 billion in 2009. These regions include Latin America, China, Eastern Europe, the Middle East, South Korea, India, Russia, and South Africa. These regions are estimated at $145.8 billion in 2010 and expected to continue aggressive growth through 2015, reaching a figure of $214.2 billion, yielding a compound annual growth rate (CAGR) of 8% from 2010 to 2020.

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.

The global market for assessment of bioequivalence of drugs was valued at $110 billion in 2011 and should reach nearly $118.7 billion in 2012.  Total market value is expected to reach nearly $157 billion in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 5.7%.

It includes andomized, two-period, two-sequence, single dose cross-over design, parallel design and replicate designs. Absolute and Relative bioavailabilty are discussed. Pharmacokinetics and Pharmacodynamics of the study designs make an important role. 

An overview of the commercial potential in  the BABE research field and analyses of global market trends, with data from 2014, estimates for 2015 and projections of compound annual growth rates (CAGRs) through 2020

Both bioavailability and bioequivalence focus on the release of a drug substance from its dosage form and subsequent absorption into the systemic circulation.Bioavailability and Bioequivalence studies are required by regulations.

The global in vitro toxicity testing market was valued at $4 billion in 2011 and more than $4.9 billion in 2012. This market is estimated to reach nearly $9.9 billion in 2017, with a compound annual growth rate (CAGR) of 14.7% for the five-year period, 2012 to 2017.

BA/BE studies are needed by regulations to guarantee remedial proportionality between a pharmaceutically comparable test item and a reference item. BA/BE studies are finished Early and late clinical trial definitions, Formulations utilized as a part of clinical trial and steadiness studies. Everybody has more heaped on their plate than any time in recent remembrance, and numerous consultant discover themselves always re-organizing their work exercises.

BA/BE research market is projected to increase to nearly $35.3 billion by 2015 from $31.5 billion in 2014. This market is expected to reach $46.8 billion by 2020, corresponding to a compound annual growth rate (CAGR) of 5.8% during 2015 to 2020 period.

BA/BE studies and conferences are required by regulations to ensure therapeutic equivalence between a pharmaceutically equivalent test product and a reference product. BE 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 productivitymetrics, it’s often said that what gets measured gets done. Part of this is human nature. Everyone has more piled on their plate than ever, and many workers find themselves constantly re-prioritizing their work activities.

Global BA/BE studies market is projected to increase to nearly $35.3 billion by 2015 from $31.5 billion in 2014. This market is expected to reach $46.8 billion by 2020, corresponding to a compound annual growth rate (CAGR) of 5.8% during 2015 to 2020 period.

Nutrient Bioavailability refers to the proportion of a nutrient that is absorbed from the diet and used for normal body functions. It includes  Enhancers of nutrient bioavailability, factors playing a critical role in absorption of nutraceuticals and herbal products. 

The global market for ethical nutrition was worth $26 billion in 2010. By 2015, it is anticipated that revenues are likely to reach nearly $44 billion, expanding at a 5-year compound annual growth rate (CAGR) of 10.9%.

In pharmacology, bioavailability (BA) is a subcategory of ingestion and is the part of a managed measurement of unaltered medication that achieves the systemic flow, one of the important pharmacokinetic properties of medications. Bioavailability is one of the crucial apparatuses in pharmacokinetics, as bioavailability must be considered when computing doses for non-intravenous courses of organization.

Global BA/BE research is projected to increase to nearly $35.3 billion by 2015 from $31.5 billion in 2014. This market is expected to reach $46.8 billion by 2020, corresponding to a compound annual growth rate (CAGR) of 5.8% during 2015 to 2020 period.

A biosimilar is a biologic therapeutic item which is duplicate of a unique item that is produced by an alternate organization. Biosimilars are authoritatively sanction forms of unique "discoverer" items, and can be produced when the first item's patent terminates. Reference to the pioneer item is a fundamental part of the approbation.

The U.S. takes the lion's share (49 percent) of the global biologics market value and generates half of the sales value growth as well. The EU accounts for 22 percent of the market's sales value and 14 percent of its value growth. In contrast, emerging markets represent just a sliver of the sales pie, with 7.5 percent share. Thus, biologics market growth is still largely driven by mature markets. The global biologics market had reached $170 billion in sales value in 2012, accounting for 18 percent of the overall market. The five top 10 global products in terms of sales volume are biologics, wherein 2008 it was just two.

Clinical pharmacology is the science of drug use in humans. Clinicians of all specialties pre-scribe drugs on a daily basis, and this is both one of the most useful but also one of the most dangerous activities of our professional lives. This track includes recent developments on behavioral pharmacology, Clinical toxicology, Clinical and experimental pharmacology.

The global molecular diagnostics market was valued at almost $21.7 billion in 2014. The total market is projected to grow at a compound annual growth rate (CAGR) of 12.5% from 2015 through 2020 to reach nearly $25.2 billion by 2015 and $45.2 billion by 2020.

For  entrepreneurs, this would be an ideal place to find out suitable investors and partners to start or expand their business.

If you’re thinking about a business opportunity that will require investment, then attend networking events in your area to identify key members of the investor community and meet other entrepreneurs. It is never too early to approach potential investors and it may be easier to create an informal relationship when you’re not actively seeking investment for your startup.