About Marcus Stavchansky, PharmD

Marcus Stavchansky, PharmD is Director, Pharmacy Services North America, Global Clinical Pharmacology at Covance, Inc. Dr. Stavchansky is a registered pharmacist and is responsible for developing, implementing and managing overall pharmacy services across all North American clinical research unit sites. His therapeutic experience includes cardiovascular disease, allergy, osteoporosis, migraine, pain management, diabetes, obesity, hormone replacement therapy, asthma, vaccinations, smoking cessation and hypercholesterolemia.

Phase I cGMP Drug Manufacture at the CRU: 3 BIG Benefits

Using a cGMP pharmacy at your CRU for Phase I drug manufacturing yields benefits in quality and safety, timeline reduction and cost efficiency.

The regulatory environment continues to move toward requiring drug manufacturing cGMP pharmacy Covance Blogat current good manufacturing practice (cGMP)-compliant pharmacies. This trend and other factors make it increasingly attractive to use cGMP compounding on-site at your CRU for early development. Let’s look at Three Big Benefits for Phase I drug manufacturing:

  1. Quality and safety
  2. Timeline reduction
  3. Cost efficiency

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Combine Compounding and Analytical Support for Speed, Efficiency, Safety, Quality and Consistency

Pharmacy

The integrity of any Phase I clinical program relies heavily on the production, supply and analysis of quality dose formulations. Historically, drug doses have been formulated, manufactured and analyzed at the contract manufacturer, which typically adds significant time and expense given the small volume and the regulatory expectations at Phase I. One solution that is becoming widely practiced is combining extemporaneous preparations at the clinical research unit with independent dose analysis. It’s a one-two punch that not only saves time and money, it provides an extra assurance of quality.

Here’s how.

Pharmacies are nimble

Contract manufacturers are built for the scale and regulatory requirements of a large Phase III clinical trial. Volume is their game. In Phase I, volume is overkill and leads to additional time and cost. Continue reading