Tuesday, May 25, 2010

Drug/Diagnostic Combinations - Personalized Medicine

Current widespread interest, industry, pharmaceutical, device, diagnostic, physician, patient and FDA is now focused on the development of drug/diagnostic combinations, drugs used to treat patients and diagnostic platforms that can provide information about how a patient may respond to treatment with that drug. The combination of drug (Rx) and diagnostic (Dx) is termed personalized medicine. The combinations are numerous and smart.

The personalized medicine approach provides numerous benefits for pharmaceutical and diagnostic companies, but most importantly, to the patient for several reasons. Most drugs are developed in accordance with the traditional development approach, Phase 1,2,3 clinical studies. Patients on clinical trial, must pass strict eligibility criteria to be enrolled and randomized to study treatment drug. Patients are informed of the study protocol design and experimental tests of the clinical trial. Patients are usually allowed participation from 18-65 years of age. Medical history is taken to assure the presence and diagnosis of disease or condition. Patient disease or condition severity is determined by scales, blood, urine, physical exam, EKG, baseline testing parameters. Patients with poorly defined underlying disease or complicated medical histories are still grouped in one category for treatment.

Much data is collected to ensure patient safety and patient well being on clinical trial. However, patients still experience adverse reactions, sometimes severe. Some patients respond to treatment drug and some patients derive no benefit from the treatment drug. The result of the traditional approach to drug development is that not all drugs work equally well in all patients. There are many factors that may affect how a patient may respond to a particular drug. Factors that may affect drug performance or patient risk/benefit, for examples are age, diet, environmental factors, psychological and physiological factors, genetic make-up of the patient, genetic changes via time and otherwise.

Therefore, it is not surprising that there is growing interest in the identification of methods and factors to determine:
  1. which patients will respond well to a particular therapy
  2. which patients are likely not to benefit from therapy
  3. which patients are likely to experience adverse reactions and side effects caused by the therapy.

Hence the advancement of drug/diagnostic combinations or personalized medicine for patients.

Whether the approach to patient therapy is traditional or personalized medicine, quality data and documentation is mandatory. QC early in the planning stages of drug development plans and diagnostic test platforms. Contact http://www.danteresources.com/.

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