The track category is the heading under which your abstract will be reviewed and later published in the conference printed matters if accepted. During the submission process, you will be asked to select one track category for your abstract.
when medicine is levelled intravenously, its bioavailability is 100%. As it may, when medicine is controlled through different courses (orally) its bioavailability by and large moderations (Reason- inadequate assimilation and first-pass digestion system) or may swing from patient to patient. Bioavailability is one of the pivotal tackles in pharmacokinetics, as bioavailability must be considered when figuring doses for non-intravenous courses of an organization.
- Track 1-1Oral Bioavailability
- Track 1-2Absolute Bioavailability
- Track 1-3Relative Bioavailability
- Track 1-4Pharmacokinetic
Bioequivalence is the similitude of two drugs that portion the same desired outcome for patients. Pharmaceutical equivalence means two drugs deliver the active components into the bloodstream at the same amount and the same rate. When gauge how well a generic drug work, scientists evaluate its bioequivalence to the name-brand version.
- Track 2-1 Pharmacokinetic studies
- Track 2-2 Pharmaceutical
- Track 2-3 In Vivo
- Track 2-4 In Vitro
BA/BE studies are needed by a directive to guarantee remedial correlation between a pharmaceutically equivalent test item and a remark item. BA/BE studies are finished Early and late clinical trial precision, Formulations applied as a part of clinical trial and steadiness studies. Everybody has more layered on their plate than any time in recent tribute, and abundant consultants discover themselves always re-organizing their work exercises.
- Track 3-1 Identical therapeutic moiety
- Track 3-2 Pharmaceutical Equivalence
- Track 3-3 Abbreviated New Drug Application
Pharmacology is the portion of science concerned about the examination of medication activity, where medication can be broadly characterized as any synthetic, regular particle which applies a biochemical or physiological effect on the cell, tissue, organ, or creature. Even more particularly, it is the investigation of the associates that happen between a living life form and synthetic mixtures that influence ordinary or odd biochemical capacity. On the off coincidental that substances have therapeutic properties, they are alleged about pharmaceuticals. Pharmacology has main two parts, pharmacodynamics and pharmacokinetics.
- Track 4-1 Toxicology
- Track 4-2 Antipathogenic capabilities
- Track 4-3 Ecopharmacovigilance
- Track 4-4 ImmunoPharmacology
A clinical trial is a research study that finds new ways to prevent, diagnose or treat disease. Cancer clinical trials test new treatments in people with cancer. These treatments investigate promising new medication, drug mixtures, new approaches to surgery or irradiation, and advances in new areas like cistron medical aid. Clinical trials area unit the ultimate step in an exceedingly long method. Testing of a replacement cytotoxic drug or treatment is finished in an orderly series of steps known as phases.
Phase 1 trial: Determine a safe dosage range and identify side effects.
Phase 2 trial: The drug or treatment works in people who have a certain disease or condition
Phase 3 trial: Use drugs or treatments and collect data that may permit the drug or treatment to be used safely.
Phase 4 trial: Area unit conducted once a drug or treatment has been approved to be used within the general public.
- Track 5-1 Observational clinical trials
- Track 5-2 Interventional clinical trials
Pharmacodynamics is described as what a drug does to the body & is the study of the biochemical, physiologic, and molecular effects of drugs on the body and involves receptor sensitivity, post receptor effects, and chemical interactions. Pharmacodynamics, with pharmacokinetics (the branch of pharmacology concerned with the movement of drugs within the body) helps to explain the relationship between the dose and response. The medicine response depends on the drug binding to its target.
- Track 6-1 Pharmacokinetic-pharmacodynamic
- Track 6-2 Pharmaceutical drugs
The European Medicines Agency's (EMA) productâ€specific bioequivalence indicates the outline harmonised regulatory desires for studies to demonstrate bioequivalence for merchandise that may have specific desires owing to their material medical, additionally to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision making.
- Track 7-1 Generics
- Track 7-2 Biowaiver
- Track 7-3 In Vitro dissolution
Biopharmaceuticals are medical drugs produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, ribonucleic acid or antisense oligonucleotides) used for therapeutic or in vivo diagnostic functions and are created by suggests that except for direct extraction from a native (non-engineered) biological source.
- Track 8-1 Monoclonal Antibodies Process
- Track 8-2 Vaccines and Viral Therapy Process
- Track 8-3 Plasma Process
- Track 8-4 ADC Process
A biosimilar product is a biologic product that is accepted based on representing that it is highly similar to an FDA approved biologic product, known as a reference product, and has no clinically meaning variations in terms of safety and effectiveness from the reference product.
- Track 9-1 SBP (Similar biologic Product)
- Track 9-2 FOB (Follow-On Biologic)
- Track 9-3 SEB (Subsequent Entry Biologic)
Pharmacokinetics is the study of a drug absorption, distribution, metabolism and elimination from the body. Pharmacodynamics describes what the drug ensures to the body. These pharmacokinetic properties determine the onset, intensity, and the duration of drug action in body. First of all the drug absorption from the site of administration permits the entry of a drug to the plasma. Secondly drug then leave plasma and distribute to the interstitial and intracellular fluids. Third, the drug is metabolized by liver and other tissues. finally, drug and its metabolites are eliminated from the body in urine, bile and feces. Pharmacokinetics mean the drug and their movements in the body. In general terms, it can be explained as an effect of drug or chemical entity on body upon administration.
- Track 10-1 Absorption
- Track 10-2 Distribution
- Track 10-3 Metabolism
- Track 10-4 Elimination
The aim of bioavailability study is to search out the dosage type influence on the biological performance of the drug, sensitivity to find variations within the rate and extent of absorption. A study style meant for estimating essential pharmacokinetic parameters differs considerably from a bioequivalence study meant for comparison the take a look at formulation with respect to a customary. Factors have to be considered in conducting a bioavailability study are rate and extent of absorption of a drug into the systemic circulation.
- Track 11-1 Pharmaceutical equivalence
- Track 11-2 Therapeutic Equivalence
- Track 11-3 Genetic Phenotyping
Drug Design defines the look of molecules that square measure complementary in form and charge to the building block target with that they move and so can bind to that. Drug development is that the method of delivery a replacement pharmaceutical drug to the market once a lead compound has been known through the method of drug discovery.
- Track 12-1 Ligand-based drug design
- Track 12-2 Rational drug discovery
- Track 12-3 Computer-aided drug design
- Track 12-4 Structure Base Drug Design
Failure at any stage would mean a large loss for the corporate. Hence, a lot of planning is required even before the project is underway. Recently, with the use of technology the process is becoming a less risky business, because of the ability of the computers to predict the possible outcomes. This will surely reduce the efforts in fruitless directions. Hence, the most important and most common biological targets for drug discovery are either enzymes regulating the biochemistry or the receptors through which many hormones and endogenous effectors show their response.
- Track 13-1 European Guidelines
- Track 13-2 FDA Guidelines
- Track 13-3 WHO Guidelines
Pharmacovigilance is outlined because the science and activities involved with the detection, assessment, understanding and hindrance of adverse reactions to medicines (i.e. adverse drug reactions or ADRs). The goal of this activity is to enhance the safe and rational use of medicines, thereby up patient care and public health.
- Track 14-1 Adverse Drug Reaction (ADR)
- Track 14-2 Adverse Event
- Track 14-3 Serious Adverse Event
Public health nutrition is the science of preventing disease, extending life and promoting health through the medium of nutrition. The aim of these operating as public health nutritionists is for everybody to realize larger health and well-being by creating healthier food and nutrition-related selections. Public health refers to any or all organized measures (whether public or private) to forestall illness, promote health, and prolong life among the population. Its activities aim to produce conditions within which individuals is healthy and specialise in entire populations, not on individual patients or diseases. Thus, public health is concerned with the total system and not only the eradication of a disease.
- Track 15-1 Macronutrients
- Track 15-2 Micronutrients
In-Vivo Bioequivalence studies:
The following sequence of criteria is beneficial in assessing the requirement for in vivo studies:
1. Oral immediate-release merchandise with general action- Indicated for serious conditions requiring assured response. Narrow therapeutic margin. Pharmacokinetics difficult by absorption seventy nada. Unfavourable physiochemical properties, e.g. low solubility, metastable modification, instability, etc. Documented evidence for bioavailability problems. No relevant information on the market, unless justification by somebody that in vivo study isn't necessary.
2. Non-oral immediate-release products.
3. Modified-release products with systemic action
In vivo bioequivalence studies are conducted with in usual manner as mentioned for bioavailability studies, i.e. the pharmacokinetic and the pharmacodynamic methods.
In-vitro Bioequivalence studies:
1. The drug product differs solely in strength of the active substance It contains, provided all the subsequent conditions hold.
2. The drug product has been slightly reformulated, or the manufacturing technique has been slightly modified by the initial manufacturer in ways in which during which can convincingly be argued to be impertinent for the bioavailability.
3. The drug product meets all the following necessities
4. a suitable IVIVC and therefore the in vitro dissolution rate of the new product is equivalent there upon of the already approved healthful product.
- Track 16-1 Pharmacodynamics Methods
- Track 16-2 IVIVC (In-Vitro In-Vivo Correlation)
- Track 16-3 Pharmacodynamics Methods
- Track 16-4 IVIVR (In-Vitro In-Vivo Relation)
The Unites States Food and Drug administration (FDA) has defined bioequivalence as. “the absence of a major distinction within the ratee and extent to that the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes obtainable at the site of drug action when administered at the same molar dose under the similar conditions in an appropriately designed study.
- Track 17-1 IND (Investigational New Drug)
- Track 17-2 NDA (New Drug Application)
The term biowaiver is functional to a regulatory finished pharmaceutical product sanction method once the record (application) is approved supported proof of equivalence completely different than through in vivo equivalence testing In Vivo Bioavailability
- Track 18-1 BCS Class I
- Track 18-2 BCS Class II
- Track 18-3 BCS Class III
- Track 18-4 BCS Class IV