Drug dissolution testing and establishing plasma drug levels in humans

Drug dissolution testing and establishing plasma drug levels in humans5

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.

Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.

The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.

Thorough learning of drug dissolution

Drug dissolution testing and establishing plasma drug levels in humans

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.

At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.

In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

All aspects of drug dissolution and establishing plasma drug levels

Drug dissolution testing and establishing plasma drug levels in humans1

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.

Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.

He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.

To join us for more information, get in touch

 

The job of the corporate controller –prospects and pitfalls

The job of the corporate controller –prospects and pitfalls3

The position of the corporate controller, or company controller, has become an important one in companies today. This is a role that has come into being following the evolution of the corporate setup, which has brought with it many changes. The corporate controller has come into existence because of these changes.

In simple terms, the corporate controller is one who can be defined as the chief accounting officer. She is to accounting what the chief executive officer is to the organization, or what the chief technology officer is to technology. In other words, the corporate controller heads the accounting department. She usually, but not necessarily, reports to the Chief Financial Officer (CFO) in large companies, and to the CEO in smaller ones.

Since this is the primary job of the corporate controller; she is given responsibility for the entire accounts aspects of the company.

A few areas of responsibility

The job of the corporate controller –prospects and pitfalls

Some of the elements for which the corporate controller is responsible include these:

  • The company’s financial statements
  • Tax compliance
  • Payroll
  • General ledger
  • Cost accounting
  • Budgeting
  • Accounts Payable
  • Accounts Receivable

People in many important positions in accounts report to the corporate controller. This is especially so in larger organizations. Some of the positions that report to the corporate controller include accounting manager, cost accounting manager, tax manager, accounts payable manager, credit manager, and payroll manager. Although this is a not a formal or strict reporting hierarchy; this is the pattern that can be generally expected in bigger companies, whereas in smaller ones, the corporate controller runs the show singlehandedly.

Get to understand the nitty-gritty of the role of the corporate controller

Do you want to understand the role of the corporate controller in greater depths? Do the prospects of becoming one entice you? Are you excited to explore the challenges, perks and risks of being a corporate controller? Then, a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is what you need.

At this seminar, Miles Hutchinson, who is President, Sales Tax Advisors, Inc., and an experienced businessman, will be the Director. From being an auditor with PriceWaterhouseCooper and the Chief Financial Officer of a one billion dollar real estate development company; Miles has been a professional speaker and consultant who has presented over 2,500 seminars and training sessions on a myriad of business and financial topics.

In order to get a thorough understanding of this topic and what it takes to be a corporate controller, please log on to The job of the corporate controller –prospects and pitfalls to enroll for this seminar.

Ways of transitioning into the position of corporate controller

The job of the corporate controller –prospects and pitfalls1

Miles will show what it takes to successfully transition into this key position. He will help participants identify the necessary core competencies of the role and become more self-assured as they work to properly define this role for them and their company. This seminar is a very practical one that is designed for financial professionals on the fast track to top management and helps to elevate people in positions such as Corporate, divisional and plant controllers, Assistant controllers; chief accountants, budget directors, Finance and accounting managers, financial analysts, accountants, and Auditors who need to understand the corporate accounting cycle to audit effectively.

Over these two days, the Director has spelt out the following agenda:

Finally, Miles will suggest recommended resources on this topic.