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Program Coordinator

Dr. Mark Papich
Phone: 919.513.6221
Email: mark_papich@ncsu.edu

Residency in Veterinary Clinical Pharmacology

Program Description:

The defining characteristics of the specialty of veterinary clinical pharmacology reside in an advanced knowledge of the many complex factors that constitute rational drug therapy in animal patients. The Residency Program in Veterinary Clinical Pharmacology at North Carolina State University is designed to provide training and practice experience for a candidate to fulfill eligibility requirements for board certification as a Diplomate by the American College of Veterinary Clinical Pharmacology (ACVCP). Residents in clinical pharmacology also will have the option of working towards an advanced academic degree in veterinary pharmacology within the Comparative Biomedical Sciences (CBS) program. This program may be viewed at the Comparative Biomedical Sciences area.

Training Components:

The residency training requirements are listed on the ACVCP Web site. This site describes the ACVCP requirements for an accredited training program and Candidate credentials requirements as currently approved by the Board of Regents.

At NCSU, the Residency Program is a three (3) year program. The first year of the training program is designed to establish the resident's knowledge base of the comparative pharmacology of principal drug groups employed in veterinary therapeutics, as well as principles of pharmacokinetics. In the second year, the resident is expected to learn the basic mechanisms and pathophysiologic features of a wide variety of diseases occurring in the various classes of domesticated animals and to understand the role of drugs in modifying the disease process. The resident will be involved with the CVM's Clinical Pharmacology Laboratory during this portion of the training period. The resident also is expected to take part in clinical teaching rounds, and take an active role consulting with clinical staff. The resident may be expected to keep a logbook of cases in which he/she played an active part in consultation. During the second year, the resident also will gain some research experience that will eventually determine the focus of the resident’s project in the third year. The third year of the training program is intended to develop the resident's knowledge and skills in specific areas that are critical to the practice of clinical pharmacology. The primary focus during the third year will be a research project designed to provide the resident with skills necessary to be a successful investigator in veterinary clinical pharmacology.

Clinical pharmacologists must be familiar with industrial and regulatory pharmacology. During the training program, the resident is expected to become familiar with the process of drug development, evaluation, regulation, and approval. This experience may be gained by visiting with one or more of the veterinary pharmaceutical companies. The resident is expected to become familiar with important aspects of the drug approval process and requirements for conducting proper clinical trials. In addition, the resident is expected to become familiar with the functions of the US Food and Drug Administration's Center for Veterinary Medicine (CVM). The resident will become familiar with regulatory veterinary medicine, drug evaluation, approval, and surveillance. A visit to the FDA may be arranged. These off-campus experiences may be arranged by the faculty advisor at a time that is convenient during the resident's program.

In addition to these experiences, while at NCSU, the resident will have the opportunity to provide consulting for the Food Animal Residue Avoidance Databank (FARAD). FARAD is a federally-funded program consisting of a computerized databank of residue avoidance information and resources. While consulting with FARAD, residents will learn the important factors that are used to determine withdrawal times for drugs administered in an extra-label manner in food producing animals.

During the training period, there will be several opportunities to gain experience in teaching. The resident will be expected to prepare didactic lectures for the second year veterinary pharmacology course. He/she also will be required to present two seminars or case presentations to pharmacology faculty, graduate students, or house officers on an area of interest. The resident will also be expected to make clinical case presentations to peers occasionally. In addition, the resident will have the opportunity to participate in the problem-based clinical teaching in the clinical services rotation for 4th year veterinary students.

Applications And Deadlines:

Candidates for residency program must also be accepted to the College’s Comparative Biomedical Sciences graduate program. To be admitted to the Clinical Pharmacology training program the Candidate must be legally qualified to practice veterinary medicine in a state, province, territory or possession of the U.S., Canada, or other country. Candidates are required to take the graduate record exam (GRE) prior to admission. For information regarding the program in Clinical Pharmacology contact Dr. Mark G. Papich. For questions about the College’s graduate program, Candidates should contact the administrator of the Comparative Biomedical Sciences program, Dr. Sam Jones at 919-513-7722, the CBS office at (919) 513-6203, fax: (919) 513-6452.

Deadline for admission of applications and all supporting documents should be received on or before February 1st for Fall Semester. Applications received after this data will not be eligible for financial aid.

Specific Objectives Of The Program:

1. Basic Knowledge

The knowledge acquired should include, but not necessarily be limited to, advanced knowledge in the following drug groups and related topics:

a. Physiochemical characteristics of drugs;

b. Mechanisms of drug action and receptor function;

c. Drugs affecting the autonomic and somatic nervous system;

d. Autacoids and drugs affecting inflammation;

e. Drugs affecting the blood and blood-forming organs and immune function;

f. Drugs affecting water, ion, and acid-base balance;

g. Hormones and hormone antagonists;

h. Drugs affecting renal function;

i. Cardiovascular drugs;

j. Drugs affecting the gastrointestinal system, including the liver and pancreas;

k. Drugs affecting the central nervous system; and

l. Antimicrobic and antiparasitic drugs.

In addition to the above, a general knowledge of the pharmacology of secondary drug groups which are ordinarily considered within the realm of other clinical specialties should be included in the training program. These would include, but not necessarily be limited to, the following:

a. General and local anesthetics (anesthesiology);

b. Oxytocic and tocolytic drugs (theriogenology);

c. Antineoplastic drugs (oncology);

d. Ophthalmic drugs (ophthalmology);

e. Drugs acting on the skin (dermatology);

f. Vitamins and minerals;

g. Toxic gases, plants, vapors, heavy metals, pesticides (toxicology); and

h. Disinfectants and antiseptics (preventative medicine and surgery).

2. Advanced Knowledge In Clinical Pharmacology

The Candidate should acquire advanced specific knowledge and skills in the discipline of clinical pharmacology. The advanced knowledge pertaining to drugs in the principal drug groups should include, but not necessarily be limited to, the following special areas:

a. Drug effects in various animal species, and interspecies differences;

b. Pharmacokinetics and drug disposition, including pharmacokinetic modeling.;

c. Drug delivery systems and drug formulations;

d. Pharmaceutical interactions and incompatibilities;

e. Drug regulations and legal requirements;

f. Therapeutic indications;

g. Drug toxicology and recognition of adverse drug effects;

h. Pathophysiology of adverse drug reactions, drug allergy, and drug toxicity;

i. Drug interactions;

j. Causes of therapeutic failure; and

k. The influence of factors such as disease, habitus, age, and pregnancy on drug disposition and effects in a patient or patient population.

3. Advanced Skills In Clinical Pharmacology

During the training program, the candidate should be able to apply the basic and advanced knowledge of pharmacology to the application and practice of clinical pharmacology. Acquisition of skills necessary to be an active Veterinary Clinical Pharmacologist can occur in several ways including clinical case experience (primary and/or consulting), participation in the conduct of clinical trials, conduct of pharmacokinetic research, conduct of therapeutic drug monitoring, practical experience at the FDA-CVM or with an animal health pharmaceutical company, attendance at clinical rounds and conferences, advanced course work, attendance at special seminars, attendance at continuing education courses, attendance at scientific meetings, journal clubs, clinical teaching activities, or combinations of these activities.

The candidate is expected to understand the basic mechanisms and pathophysiologic features of a wide variety of diseases occurring in animals. The candidate is expected to understand the role of drugs in modifying the disease process, and the potential complications caused by the drugs administered. The candidate is expected to be familiar with recent advances in chemotherapy and therapeutics of serious diseases. In addition, the candidate is expected to acquire the skills needed to undertake investigations in clinical pharmacology. To meet this requirement, the candidate is expected to have an understanding of the analytical and statistical methods used to investigate the pharmacokinetics and pharmacodynamics of drugs in clinical patients and experimental animals. The candidate is expected to understand the design and interpretation of experiments designed for pharmacology studies in laboratory or clinical animals. The candidate will be expected to understand the animal drug regulations in the United States and the drug approval process for new animal drugs.

The candidate will be expected to understand the clinical pharmacology pertaining to managing and treating disease and complex therapeutic problems such as:

a. Management of pain.

b. Management of inflammation.

c. Management of infections.

d. Management of medical emergencies (e.g., circulatory shock, cardiac arrhythmias, equine colic, pulmonary edema, thromboembolism, diabetic ketoacidosis, bronchoconstriction, etc.).

e. Management of specific organ failures and neoplasia.

f. Recognition and management of drug toxicity and adverse drug reactions of either an acute or chronic nature.

g. Recognition and management of drug interactions.

h. Factors affecting drug disposition and drug action (pharmacokinetics and pharmacodynamics), including physiologic state (e.g. species, age, gender, etc.), pathologic state (disease) and drug interactions.

In addition to an advanced knowledge in the use of drugs for treatment of various diseases, and the complications thereof, the candidate is expected to possess the skills necessary to be an active Veterinary Clinical Pharmacologist. These skills include, but are not limited to:

a. Interpretation of experimental and statistical data obtained from drug studies performed in vitro, in vivo, and ex vivo.

b. Planning and interpretation of results of clinical trials for evaluation of safety and efficacy of veterinary drugs.

c. The use and interpretation of statistical methods to evaluate drug studies in vitro and in vivo.

d. A general knowledge of the analytical methods used to detect and quantify drugs in animal body fluids and tissues(for example, HPLC, RIA, FPIA). The candidate should possess a practical understanding of assay validation and quality control. Some hands-on experience with drug analytical methods is desired.

e. Planning and interpreting pharmacokinetic studies in animals, including an understanding of pharmacokinetic methods, modeling and techniques. It is expected that the candidate be familiar with the use of at least one of the pharmacokinetic software programs (eg, WinNonlin, WinNonMix, SAAM-II, etc). Training courses and materials are offered through the sponsors of each of these programs at remote sites if training cannot be offered at the institution.

f. Evaluation of drug therapy in patients through the application of therapeutic drug monitoring, pharmacokinetic, and pharmacodynamic methods. Some experience in therapeutic drug monitoring in clinical patients is recommended.

g. Calculation of the dose of drugs from knowledge of the minimum effective drug concentration, bioavailability, effective plasma drug concentrations, route of elimination, and other pharmacokinetic data. Similarly, the candidate will be expected to be able to modify dosage regimens to accommodate pharmacokinetic alterations caused by disease.

h. A general knowledge of the important species differences in response to pharmacologic approaches to therapy.

i. A practical understanding of the process of veterinary drug development and approval.

j. Understanding of the legal and regulatory considerations pertinent to extra-label drug use, drug compounding, prescription writing, and responsibilities for using and dispensing controlled substances. This should include an understanding of the AMDUCA legislation and current FDA policy guidelines.

k. The candidate is expected to have an understanding of the regulatory issues pertaining to drug administration to food animals. This should include knowing the list of banned drugs in food animals, an understanding of how drug withdrawal times are determined, and how extended withdrawal times are calculated. A familiarization with FARAD is recommended.

Research Requirement

As part of the training program, the candidate must conduct research that addresses problems or hypotheses pertinent to veterinary clinical pharmacology.

a. The research should be of publishable quality.

b. The research may be a component of the candidate’s dissertation research for an advanced degree.

c. Basic pharmacology research without direct veterinary clinical implications may not be adequate to fulfill the research component of a training program.

d. Two manuscripts will be required before the candidate is eligible to take the Phase II ACVCP Examination. These scientific reports must be based on research that addresses problems or hypotheses pertinent to veterinary clinical pharmacology. Both manuscripts must be non-review articles, published in peer review journals. At least one of the articles must be an original research article; the other article may be a case study. The candidate must be listed as first author on at least one of the required articles. Letters of final acceptance from editors will be sufficient to meet this requirement.

Course Work Requirement

A training program in Veterinary Clinical Pharmacology must include advanced course work in areas needed for expertise in clinical pharmacology. Courses required for fulfillment of the D.V.M. (or equivalent) degree are not allowed to meet this requirement. However, courses taken to fulfill requirements for an advanced degree (eg, PhD, MS) are allowed. Advanced course work also may include in-depth focused training seminars. Graduate courses exist at NCSU to meet this requirement. The candidate will be required to document courses taken at the time application is made to the Credentials Committee.

Specific courses may include, but are not limited to the following:

a. Pharmacokinetics

b. Advanced Pharmacology and Principles of Pharmacology

c. Biostatistics and Experimental Design

d. Analytical Chemistry

e. Microbiology

f. Toxicology

Clinical Requirement

The clinical requirement may be met in two ways (A or B below) or a combination thereof:

1. Clinical veterinary experience, which may include, but is not limited to a clinical internship or residency, or at least one year of clinical experience in veterinary practice. If Candidates select this option, they are expected to complete this phase of the clinical requirement prior to admission into the clinical pharmacology training program. The scope and nature of this experience must be described when the Candidate submits an application.

Or

2. Two years of clinical experience in the skills necessary to become proficient as a clinical pharmacologist. This training program should provide the candidate the opportunity to practice the skills of a clinical pharmacologist within a clinical milieu. This may include, but need not be limited to:

a. Implementation and evaluation of a therapeutic clinical trial

b. Management or consultative support of complex therapeutic problems in veterinary species.

c. Identification and management of adverse drug reactions.

d. Interpretation of microbiology culture and susceptibility data to guide the clinical management of a bacterial infection.

e. Therapeutic drug monitoring.

f. Develop drug protocols for extra-label drug use in food animals.

g. Determine extended withdrawal times for food animals that have been administered drugs in an extra-label manner.

h. Individualize drug dosage in clinical patients.

Study Materials

The following list contains references the Candidate should be familiar with during the ACVCP training program. This reference list will be used as a source of questions for the Phase I and Phase II ACVCP Examination, but the source of questions is not necessarily limited to this reference list. Candidates also are encouraged to consider contemporary articles in reputable journals pertaining to veterinary clinical pharmacology and applied therapeutics.

1.  ACVCP website:  www.acvcp.org  (website with instructions for clinical pharmacology candidates).
2.  Riviere JE, & Papich MG (editors):   Veterinary Pharmacology and Therapeutics Ninth  Edition.  Wiley-Blackwell Press, 2009.
3.  Brunton L, Chabner B, and Knollman B (editors): Goodman and Gilman's The Pharmacological Basis of Therapeutics, Twelfth Edition, 2011.  McGraw Hill.
4.  Katzung B, Masters S, & Trevor A, (editors):  Basic and Clinical Pharmacology 12/E (LANGE Basic Science).  McGraw Hill Medical (Lange Series) 2012.
5.  Papich MG.  Saunders Handbook of Veterinary Drugs, 3rd Edition. Elsevier.  2011.

7. Pharmacokinetic resources:

a. Pharsight

b. SAAM (Simulation, Analysis and Modeling)

c. Biosoft

8. FDA

9. Internet WWW Sites:

a. FDA and regulatory issues

b. United States Pharmacopeia

c. Drug monographs at AAVT

 

Journal Club

Clinical pharmacologists should regularly peruse important journals for the purpose of maintaining a current knowledge-base in the discipline of clinical pharmacology and drug therapy. At NCSU there is an organized pharmacology journal club that will meet regularly during the academic year to discuss and critique current articles of importance to clinical pharmacology is encouraged. Important journals include, but are not limited to:

Program Supervisor

Dr. Mark G. Papich is a Professor of Clinical Pharmacology, and Supervisor of the Clinical Pharmacology Laboratory in the College of Veterinary Medicine at North Carolina State University.  He is a diplomate in the American College of Veterinary Clinical Pharmacology (ACVCP), and has served as president of ACVCP.  He is also a Fellow in the American Academy of Veterinary Pharmacology and Therapeutics.  He has served on the Council of Experts and Chairman for the Veterinary Drugs Expert Committee for the United States Pharmacopeia (USP) and a member and current chairholder of the Clinical Laboratory Standards Institute (CLSI) Veterinary Antimicrobial Susceptibility Testing subcommittee (VAST).  He served as a member of the Veterinary Medicine Advisory Committee of the Food and Drug Administration (FDA).  He has taught veterinary pharmacology for over 20 years.  He has authored/edited six books on veterinary pharmacology and is one of the editors of the 9th edition of Veterinary Pharmacology and Therapeutics.  He is author or co-author of 161 research papers published in refereed journals and has authored 85 book chapters, and review papers.  A list of his current publications can be found at this site:

http://www.ncbi.nlm.nih.gov/pubmed?term=Papich%20MG[Author]

In 2009 he was awarded the AAVPT Teaching Award, in recognition of 25 years devoted to teaching and his contribution to clinical pharmacology.  In 2008 he was awarded the NCSU Huffman Leadership Award, in recognition of outstanding contributions to NC State University College of Veterinary Medicine, and also in 2008, was awarded the Pfizer Award for Research Excellence, for outstanding achievement and dedication in the field of Veterinary Medicine.  He has also delivered hundreds of presentations on veterinary pharmacology at national and international veterinary meetings, conferences and symposia.

Contact Information:

Mark G. Papich

College of Veterinary Medicine

North Carolina State University

1060 William Moore Drive

Raleigh, North Carolina, USA  27607

Phone:  919-513-6221

Fax:  919-513-6465

Email:  mark_papich@ncsu.edu

 

Affiliated Faculty

Kevin L. Anderson, DVM, PhD. Professor of Ruminant Medicine. Interests and expertise: Drug disposition in dairy cattle.

Ronald Baynes, DVM, PhD, Professor. Department of Population Health and Pathobiology (PHP). Interests and expertise: pesticides and toxicants in animals, antiparasite drugs in animals, and residue avoidance in food animals, (FARAD).

Jennifer Davis, DVM, PhD, Diplomate ACVIM and ACVCP.  Expertise in pharmacokinetics, equine and food animal medicine and therapeutics.

Keven Flammer, DVM. Professor of Companion Avian Medicine. Department of Clinical Sciences. Interests and expertise: Disposition of antimicrobial drugs in pet birds.

Lloyd N. Fleischer, PhD. Professor of Pharmacology/Biochemistry. Molecular Biomedical Sciences Department Interests and expertise: Anti-inflammatory drugs, role of cytokines in disease, drugs that affect the central nervous system.

Bernie D. Hansen, DVM. Department of Clinical Sciences. Interests and expertise: Evaluation, recognition, and treatment of acute pain in animals.

Elizabeth (Lizette) M. Hardie, DVM, PhD. Professor of Surgery. Department of Clinical Sciences. Interests and expertise: Use of nonsteroidal anti-inflammatory drugs and opiates in clinical patients, preventing post-operative pain in animals.

M. Christine McGahan, MS, PhD. Research Professor of Pharmacology. Molecular Biomedical Sciences Department Interests and expertise: Ocular pharmacology.

Clifford R. Swanson, DVM, MS. Associate Professor of Anesthesiology. Molecular Biomedical Sciences Department Interests and expertise: Clinical anesthesiology, drug information, interactive multimedia courseware for education purposes.

Michael K. Stoskopf, DVM, PhD. Professor of Aquatic/Wildlife Medicine. Department of Clinical Sciences. Interests and expertise: Drug disposition in aquatic and wild animals.

Shelly L. Vaden, DVM, PhD. Associate Professor of Internal Medicine. Department of Clinical Sciences. Interests and expertise: Gastrointestinal, and urinary diseases in animals, pharmacokinetics of antimicrobial and immunosuppressive drugs