Human organ/tissue growth algorithms that include obese individuals and black/white population organ weight similarities from autopsy data.

Physiologically based pharmacokinetic (PBPK) models need the correct organ/tissue weights to match various total body weights in order to be applied to children and the obese individual. Baseline data from Reference Man for the growth of human organs (adrenals, brain, heart, kidneys, liver, lungs, pancreas, spleen, thymus, and thyroid) were augmented with autopsy data to extend the describing polynomials to include the morbidly obese individual (up to 250 kg). Additional literature data similarly extends the growth curves for blood volume, muscle, skin, and adipose tissue.

Windows based general PBPK/PD modeling software.

A physiologically based pharmacokinetic (PBPK) model and program (called PostNatal) was developed which focuses on postnatal growth. Algorithms defining organ/tissue growth curves from birth through adulthood for male and female humans, dogs, rats, and mice are utilized to calculate the appropriate weight and blood flow for the internal organs/tissues. This Windows based program is actually four linked PBPK models with each PBPK model acting independently or totally integrated with the others through metabolism by first order or Michaelis-Menten kinetics.

Postnatal growth considerations for PBPK modeling.

A physiologically based pharmacokinetic (PBPK) model and Windows-based program (called PostNatal) was developed that focuses on postnatal growth, from birth through adulthood, using appropriate growth curves for each species and gender. Postnatal growth algorithms relating organs/tissues weights with total body weight for male and female humans, dogs, rats, and mice are an integral part of the software and are utilized to assign the appropriate weight and blood flow for each of 22 organs/tissues for each simulation. Upper limits of body weight were chosen that reflect the available data used to define the algorithms; above these limits a set percent body weight was assigned to all organs/tissues.

Physiologically based pharmacokinetic/pharmacodynamic model for acrylamide and its metabolites in mice, rats, and humans.

A physiologically based pharmacokinetic model was developed for acrylamide (AA) and three of its metabolites: glycidamide (GA) and the glutathione conjugates of acrylamide (AA-GS) and glycidamide (GA-GS). Liver GA-DNA adducts and hemoglobin (Hb) adducts with AA and GA were included as pharmacodynamic components of the model. Serum AA and GA concentrations combined with urinary elimination levels for all four components from male and female mice and rats were simulated from iv and oral administration of 0.

Improving predictive modeling in pediatric drug development: pharmacokinetics, pharmacodynamics, and mechanistic modeling.

A workshop was conducted on November 18-19, 2004, to address the issue of improving predictive models for drug delivery to developing humans. Although considerable progress has been made for adult humans, large gaps remain for predicting pharmacokinetic/pharmacodynamic (PK/PD) outcome in children because most adult models have not been tested during development. The goals of the meeting included a description of when, during development, infants/children become adult-like in handling drugs.

Preparing for asset retirement.

Statement of Financial Accounting Standards (SFAS) No. 143 requires organizations to recognize a liability for an asset retirement obligation when it is incurred--even if that occurs far in advance of the asset's planned retirement. For example, organizations must recognize future costs associated with medical equipment disposal that carries hazardous material legal obligations.

Designing long-term disability plans: tax efficiency vs. maximizing wage replacement.

The tax treatment of long-term disability plans raises difficult questions for employers and employees, as it necessitates a tradeoff between tax efficiency and maximizing wage replacement for disabled workers. By using simplified case examples, this article illustrates the advantages and disadvantages of different plan design choices. The authors conclude that, in most cases, long-term disability coverage should be mandatory but that employees should be given the choice to decide whether their coverage is taxable.

AICPA allows low-cost options for compiled financial statements.

The AICPA Accounting and Review Services Committee's (ARSC) SSARS No. 8, Amendment to Statement on Standards for Accounting and Review Services No. 1, Compilation and Review of Financial Statements, issued in October 2000, allows financial managers to provide plain-paper, compiled financial statements for the exclusive use of management.

AICPA standard can help improve audit committee performance.

The AICPA's Auditing Standards Board issued Statement on Auditing Standards (SAS) No. 90, Improving the Effectiveness of Corporate Audit Committees, in response to a related Securities and Exchange Commission (SEC) rule change. Under the standard, audit committees of publicly traded organizations must enter into discussions with their organization's auditors regarding the quality and the acceptability of the accounting principles that have been applied in the organization's financial statements.

Analysis of methylmercury disposition in humans utilizing a PBPK model and animal pharmacokinetic data.

Physiologically based pharmacokinetic (PBPK) models are excellent tools to aid in the extrapolation of animal data to humans. When the fate of the chemical is the same among species being compared, animal data can appropriately be considered as a model for human exposure. For methylmercury exposure, sufficient data exist to allow comparison of numerous mammalian species to humans.

The FASB explores accounting for future cash flows.

The FASB's Statement of Financial Accounting Concepts No. 7, Using Cash Flow Information and Present Value in Accounting Measurements (Statement No. 7), presents the board's views regarding how cash-flow information and present values should be used in accounting for future cash flows when information on fair values is not available.

IRS issues new disclosure rules for tax-exempt organizations.

The IRS earlier this year issued new regulations that tax-exempt organizations must follow in disclosing to the public certain documents as directed by the Omnibus Budget Reconciliation Act of 1987 (OBRA87) and the Taxpayer Bill of Rights 2 of 1996. The new rules went into effect June 8, 1999. Complying with these rules may pose difficulties in terms of the increased exposure of the documents that must be disclosed, increased labor, time limitations, and penalties, some of which can be imposed upon a director or officer.

Mathematical modeling of human embryonic and fetal growth rates.

A mathematical model for human embryonic/fetal growth data from implantation to birth is developed. In previous work, it was shown that an unbiased estimate for human fetal growth data from about day 50 post-conception until term could be calculated from the Gompertz equation. This period represents a range of embryonic/fetal weights from one to 3500 g.

FASB Statement No. 136 clarifies transfers of assets.

FASB Statement of Financial Accounting Standards No. 136, Transfers of Assets to a Not-for-Profit Organization or Charitable Trust That Raises or Holds Contributions for Others, provides guidance and establishes accounting standards for the transfer of assets from donors to not-for-profit organizations that may then transfer those same assets to a beneficiary organization. Recipient organizations that accept financial assets from a donor and agree to use those assets on behalf of a specified unaffiliated beneficiary or transfer those assets, the return on investment of those assets, or both to that beneficiary must recognize the assets received from the donor and recognize the assets' fair value as a liability to the beneficiary.

FASB Statement No. 132 simplifies benefits disclosures.

In February 1998, the FASB issued Statement of Financial Accounting Standards No. 132, Employers' Disclosures about Pensions and Other Postretirement Benefits. The new standard is designed to streamline pension and other postretirement benefits disclosures in public and nonpublic entities' financial statements.

New AICPA standards aid accounting for the costs of internal-use software.

Statement of Position (SOP) No. 98-1, "Accounting for the Costs of Computer Software Developed or Obtained for Internal Use," issued by the American Institute of Certified Public Accountants in March 1998, provides financial managers with guidelines regarding which costs involved in developing or obtaining internal-use software should be expensed and which should be capitalized. The SOP identifies three stages in the development of internal-use software: the preliminary project stage, the application development stage, and the postimplementation-operation stage.

SOP 98-5 brings uniformity to reporting start-up costs.

The American Institute of Certified Public Accountants (AICPA) issued Statement of Position (SOP) No. 98-5, Reporting on the Costs of Start-Up Activities, in April 1998 to provide organizations with guidance on how to report start-up and organization costs. Because some companies were expensing start-up costs while other companies were capitalizing start-up costs with a variety of periods over which to amortize costs, it was difficult to compare companies' financial statements.

Physiological "constants" for PBPK models for pregnancy.

Physiologically based pharmacokinetic (PBPK) models for pregnancy are inherently more complex than conventional PBPK models due to the growth of the maternal and embryo/fetal tissues. Physiological parameters such as compartmental volumes or flow rates are relatively constant at any particular time during gestation when an acute experiment might be conducted, but vary greatly throughout the course of gestation (e.g.

A computer model and program for xenobiotic disposition during pregnancy.

A physiologically based pharmacokinetic computer model and program have been developed that depict internal disposition of chemicals during pregnancy in the mother and embryo/fetus. The model is based on human physiology but has been extended to simulate laboratory animal data. The model represents the distribution, metabolism, and elimination of two chemicals in both the maternal and embryo/fetal systems; the program handles the two chemicals completely independently or interactively with the two chemicals sharing routes of metabolism and/or elimination.

Mathematical analysis for teratogenic sensitivity.

A mathematical structure is described for determining teratogenic sensitivity or susceptibility from analysis of malformation incidence, dose-response, and pharmacokinetic data obtained during pregnancy as a result of exposure to a teratogenic agent. From the dosage or exposure of laboratory animals, embryonic and maternal concentrations of the xenobiotic are calculated using a physiologically based pharmacokinetic (PBPK) model. Malformations observed in the progeny are linked to the PBPK-derived target tissue concentrations with a model for the sensitivity calculated as a function of the embryonic age.

Making unofficial inventory official. Financial managers who record and control unofficial inventory make the most of a valuable asset.

All healthcare organizations maintain supplies in their facilities that have not been booked as assets on their general ledgers. This unofficial inventory is often overlooked because it is not as significant a cost-driver as salaries and capital equipment. But unofficial inventory can affect an organization's bottom line when it is not reflected as an asset on statements of activities.

SFAS No. 124, accounting for investments: the rules have changed.

Under SFAS No. 124 "Accounting for Certain Investments Held by Not-for-Profit Organizations," issued in November 1995, not-for-profit healthcare organizations must report investments in equity securities that have readily determinable market values and all debt securities at fair value. SFAS No.

Implementing SFAS No 121: Accounting for Impaired Assets.

In March 1995, FASB issued Statement of Financial Accounting Standards (SFAS) No. 121: "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of." It establishes accounting standards for assets whose carrying costs have been overstated due to a variety of circumstances that have reduced the value of the assets.

Identifying best practices for audit committees.

Most healthcare organizations have an audit committee of the governing board, or a finance committee, that fulfills the audit oversight function. Financial managers play a key role in shaping the content, agency, and operation of the audit committee. The findings of a recent research study conducted by Arthur Anderson & Co.