Track 1: Bioavailability

The completely bioavailability of a drug, when operated by an extravascular route it is generally less than one. Several physiological factors bring down the availability of drugs advance to their entries into the systemic circulation. Whatever a drug is taken with or without food will also work on absorption, other drugs taken simultaneously, may alter absorption and first-pass metabolism, intestinal motility alters the termination of the drug and may affect the degree of chemical humiliation of the drug by intestinal micro-flora. Disease states affecting liver metabolism or gastrointestinal function will also have an conclusion.

• Hepatic first-pass effect
• Factors affecting bioavailability
• Route of administration
• Relative bioavailability
• Absolute bioavailability

 

Track 2: Bioequivalence

The QUALITY consequently two drugs with similar active COMPONENT such as a logo drug and its generic equivalent  or two unconnected dosage structures as oral suspension and tablet of the same drug possess homogenous  bioavailability and produce the same outcome at the site of physiological activity after commanding of the identical molar dose under the atmosphere, are close to such a degree that their conclusion can be look forward to be virtually the same

• In vitro Bioequivalence
• Clinical trial formulations
• Therapeutic index
• Generic drugs
• Bioequivalence of endogenous substances

 

Track 3: Factors Affecting Bioavailability

Heterogeneousness has Many drugs carbamazepine and excipients, exhibit polymorphism. Polymorphs have dissimilar solubility. Dilution dissolving by amphiphilic combination   Endogeneous,amphiphiles. They are bile salts, monooleins, lecithin. Exogeneous amphiphiles and Extent of Ionization.

 

Track 4: Regulatory Requirements for Bioequivalence

The bioequivalence for oral drug is determined by contrast the relative bioavailability of the logo drug compared to the generic drug. Food effect bioavailability are commonly conducted for new drugs and drug effect during the investigational new  drug (IND) phase to assess the effects of food on the rate and proportions of engrossment of a drug when the drug product is management shortly after a meal fed conditions, as compared to commanding under diet conditions.

• WHO Approaches
• FDA Approach and regulations
• TGA and risk management approach
• Food-Effect Bioavailability and Fed Bioequivalence Studies
• European Guidelines

 

Track 5: Bioequivalence Protocols

In vivo/ In vitro studies: In vitro drug release connecting imitation, and drug intelligence into porcine skin ex vivo, it comes about compared with published human in vivo studies. Two betamethasone vale rate (BMV) formulations and three retail econazole nitrate (EN) creams were estimated. Dermatopharmaco kinetics. in vitro ransom test. In vitro skin penetration Red, itchy circular skin rash, and scaly.

 

Track 6: Study Designs

The design of any study is more relevant. Than analysing the outcome, as a badly designed study cannot at all be recovered, where as a badly look over study can be readdress, to reach a worthwhile. Rather, the layout of the study worthwhile how the data give rise to can be best inspects. The scientific righteousness of the study and the trustworthiness of the data from the study those in essence depend on the study design. Study designs are set of technique and make used to collect and analyse data in study. Mostly speaking and there are 2 types of study designs: analytical studies and descriptive studies.

 

Track 7: BA/BE studies of Biologics and Biosimilars

A biologic product is a organization, acting as a therapeutic drug or vaccine, establish from living organisms, either, human, yeast, animal, microorganisms. Biologics are easy going of proteins and their element amino acids, carbohydrates are sugars, nucleic acids as DNA. Biologics may moreover be tissues or cells used in transplantation. The Biosimilars, few times mention are on biologic, is a therapeutic drug that is most alike but not structurally homogeneous to a brand logo biologic

• Cancer therapeutics
• Cardiovascular therapeutics
• Diabetes therapeutics
• Analytical strategies
• Biosimilars: Regulatory approach

 

Track 8: Significance of BA/BE Studies

 Bioequivalence studies are necessary for the growth of a pharmaceutical compound in the pharmaceutical industry. Their reasoning is the observe of pharmacodynamics and pharmacokinetic parameters after the commanding of tested drugs Bioequivalence is a word in pharmacokinetics used to assess the look forward to in vivo biological equivalence of two proprietary production of a drug.

• Novel Drug Delivery Systems- BA/BE approach
• Generic drugs: Current claims and future directions
• BA/BE Studies for Immediate-Release Solid Oral Dosage Forms
• Bioequivalence analysis of highly variable drugs
• Bioavailability Study for cancer drugs
• Food-effect Bioavailability and fed Bioequivalence studies

 

Track 9: Clinical Trails

Clinical trials are a group of research that studies new tests and medicaments and estimate their effects on human health outcomes. People subject to take part in clinical trials to test medical interruption. Together with drugs, cells and other biological products, radiological procedures, devices, surgical procedures conduct treatments and preventive care. Clinical trials are carefully block out, judge and completed, and need to be accept before they can start. People of all ages can play a part in clinical trials, together with children.

 

Track 10:  Clinical Pharmacology and Therapeutics and Trails

Clinical pharmacology sits at the annexation between elementary pharmacology and the effective drug therapy of human disease. Because of the dominance of pharmacotherapy in present time therapeutics, clinical pharmacology has enchange indispensable for the growth of surgery as well as for the proper understanding and operation of contemporary medicine.

• Pre-clinical research/trial
• Clinical Trial Management
• Clinical research phase studies
• In Vitro and In Vivo studies
• Clinical Study Designs
• Bioequivalence Protocols: In vitro-In vivo correlation

 

Track 11:  Challenges in Drug Design and Development

Animal models generally cannot recapitulate a totally disorder or disease. Challenges connected to heterogeneity of the patient population energy are reduce with increased clinical phenotyping and endotyping. Greater emphasis on human data power lead to improved target identification and validation

• Computer-Aided Drug Design
• Rational Drug Design Approach
• Novel Approach
• Topical Drug Development
• Genetics in Drug Development

 

Track 12: Drug Metabolism

It is used to express the biotransformation of pharmaceutical substances in the body. so that they can be terminate more simply. The mass of metabolic processes that required drugs takes place in the liver, as the enzymes that facilitate the reactions are reduced. Most drugs must flow through the liver; this is the primary site of drug metabolism. Once in the liver, enzymes transforms prod rugs into active metabolites and   convert active drugs into inactive forms

• Phase 1 metabolism of drug: P450 (CYP450)Enzyme
• Phase I vs. Phase II Metabolism
• Food/herbal remedies- drug interaction
• Drug Efficacy and toxicity
• Plasma Concentrations and Drug Effects

 

Track 13: Biosimilars

A Biosimilars is a biologic medical  product highly alike to another already accept biological medicine. Inside he European Union, Biosimilars are approved according to the same level  of pharmaceutical quality, safety and efficacy that request to all biological medicines.

• Biosimilars Development
• Biosimilars Pipeline
• Biosimilars in Therapeutics
• Biosimilars Pipeline

 

Track 14: Pharmacology- PK & PD approach

They reported the pharmacokinetics of determine antibiotic classes in critically un well patients and antibiotic pharmacodynamics resource were judge. Antibiotics and antibiotic classes judge cover aminoglycosides, beta-lactams it includes carbapenems, colitis, glycopeptides, tigecycline, fluoroquinolones, lincosamides and linezolid.

• Pharmacokinetics
• Pharmacodynamics
• Drug Interactions
• Drug Safety and Efficacy
• Posology& Development

 

Track 15: Pharmaceutical Formulations

The expression frequently functions in a way that takes in different dosage forms. The dosage conformation is the pharmaceutical drug out come as marketed for use with a unrelated mixture of active substance and inactive components. It has a capsule shell testimonial into a specific dose. Pharmaceutical statement is the multistep operation where the active drug is mixed with all other components by in view of the factors of polymorphism, particle size, pH, and solubility and becomes the final beneficial medicinal product

• Solid Dosage Form
• Topical Dosage form
• Parenteral Dosage form
• Immediate-Release Products
• Modified-Release Products

 

Track 16:  Clinical Research Vs Clinical Trails

Clinical trials are investigation studies are carry out  in people that are aimed estimate a medical, surgical and behavioural interposition Clinical trials are research studies performed in people that are aimed valuate, a medical, surgical, and  behavioural intervention. Clinical trials are testing studies thorough in people that are aimed at estimate a medical, surgical and behavioural intervention.

• Pre-clinical research/trial
• Clinical Trial Management
• Clinical research phase studies
• In Vitro and In Vivo studies
• Clinical Study Designs
• Bioequivalence Protocols: In vitro-In vivo correlation

 

Track 17:  BCS & IVIVC Based Bio waivers

It is a substructure for compartment, drug material based on its solubility and absorptive It is a drug development device to explain ‘bio waiver’ in concurrence with the dissolution of the drug product. (BCS) based bio waivers The term bio waiver is request to a regulatory drug approval process when the dossier is accept based on conformation of equivalence other than in vivo bioequivalence test

• BCS bio waivers
• Preclinical and clinical testing for oral drug delivery
• In vitro preclinical ADME/BCS testing
• In vitro drug product research
• Dissolution testing in drug formulation

 

Track 18: Recent approaches to Biosimilars

Biosimilars are medicines that are mostly parallel to their accept reference biologics as they declare to have no clinical variability  in purity, potency, and safety these  medicines have a extreme impact on patients suffering from many debilitating and life-threatening diseases, few as rheumatoid arthritis, multiple sclerosis , leukaemia’s, lymphomas, ,cardiac myopathies , and various oncogenic cancers

• Cancer therapeutics
• Cardiovascular therapeutics
• Diabetes therapeutics
• Analytical strategies
• Biosimilars: Regulatory approach

 

Track 19: Drug Safety

Pharmacovigilance Scope Drug Safety has very unselective. a career path with the doubtless to work in both permanent and contracting capacities. It Depends on the amount of exposure achieved, career development in Drug Safety  it can incline towards line management, and a more technical direction that includes risk management, signal detection, and epidemiology