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A Closer Look: Q&A with Jashvant Unadkat

Jash Unadkat headshotJashvant “Jash” Unadkat has been a Professor in the Department of Pharmaceutics, School of Pharmacy,  at the University of Washington since 1985. He is the 2012 recipient of the American Association of Pharmaceutical Scientists (AAPS) Research Achievement Award in Pharmacokinetics, Pharmacodynamics and Drug Metabolism. Jash discusses his new NIDA grant and its goals of making treatment and medications safer for women who need pharmacological assistance for substance use and mental health issues.

1. Tell us a bit about the importance of your new NIDA grant.

It’s inevitable that pregnant women sometimes need to take medicinal drugs; many women have clinical conditions that need to be treated, including substance use. Through research, our goal is to improve treatment of pregnant women who need to take medications.  We will develop guidelines for prescribers on how to adjust dosages during pregnancy to maintain efficacy and reduce toxicity of drugs. We also want to develop and provide new tools to predict fetal exposure to drugs during pregnancy and to evaluate risks to the baby, especially to drugs of abuse.

2. Please tell us about the three subprojects within this grant.

The three subprojects will each examine different drug types and their disposition in pregnant women and their fetuses: the drug abuse treatment methadone and buprenorphine, amphetamines and other illicit drugs, and the antidepressant bupropion.  Then, we will work with the British company Simcyp to synthesize the data from all three projects. Simcyp uses a population-based simulator to conduct physiological pharmacokinetic modeling — a mathematical modeling technique for predicting the disposition of synthetic or natural chemical substances in virtual human populations. The analysis will help predict how pregnant women and their fetuses respond to illicit drugs, medications for drug abuse, and antidepressants.

3. What is the timeline for your research? When can we expect to hear about results?

This is a 5 year grant.  We will publish the results from our research in years 2-5.

4. One of your proposed goals is to make treatment and medications safer for women who need pharmacological assistance for substance use and mental health issues. Please describe the scope of the problem and how your research will contribute to these issues.

Latest statistics indicate that 64% of pregnant women ingest at least one licit drug during pregnancy other than a vitamin or mineral supplement for the treatment of a variety of clinical conditions, including depression and diabetes. About 5-10% of pregnant women are prescribed drugs which are potential teratogens,  and the use of drugs is higher in early vs. late pregnancy. Illicit drug use by pregnant women in the US has increased markedly over the past three decades. About 5% of pregnant women in the US report illicit drug use.

Illicit drug use in pregnancy is a major risk factor for maternal morbidity and neonatal complications which often require treatment.  Whenever a pregnant woman ingests drugs (licit or illicit), the fetus is also exposed to the drugs. Licit drugs are routinely used off-label during pregnancy, i.e. without the clinical data about the dose, maternal-fetal pharmacokinetics (PK), safety, or efficacy of the drug necessary for rational design of drug dosing regimens for pregnant women. The FDA never approves a drug for the adult non-pregnant populations without such data. Our research (as described above) hopes to begin to rectify these large gaps in knowledge.

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