Different stages of the drug development and approval process in the USA, lead from preclinical trials (testing in animals), first application in humans through limited and broad clinical tests, to postmarketing studies.


By Dale E. Wierenga, Ph.D. and C. Robert Eaton
Office of Research and Development
Pharmaceutical Manufacturers Association

'In reviewing this report, it is important to keep in mind the realities of the drug discovery and development process. The U.S. system of new drug approvals is perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment.'

See also Phase 1 2 3 4 Drug Trials, Food and Drug Administration, and European Medicines Agency.

(MIP) Angiography (Doppler) images can be processed by Maximum Intensity Projection to interactively create different projections. Although the maximum intensity projection (MIP) post processing algorithm is sensitive to high signal from inflowing spins as used in MRI, it is also sensitive to high signal of any other etiology as used in ultrasound imaging. The MIP connects the high intensity dots of the blood vessels in three dimensions, providing an angiogram that can be viewed from any projection. Each point in the MIP represents the highest intensity experienced in that location on any partition within the imaging volume.
For complete interpretation the base slices should also be reviewed individually and with multiplanar reconstruction (MPR) software. The MIP can then be displayed in a CINE format or filmed as multiple images acquired from different projections.

See also 3D Ultrasound.

From Siemens Medical Systems;
'This extremely flexible system supports targeted applications for OB/GYN, Radiology, Internal Medicine, Urology, and Prostate Brachytherapy. The large transducer selection, most with high-frequency capabilities, provides the right tool for general imaging, radiology, and internal medicine applications.'

(TEE) Transesophageal echocardiography provides a superior view of cardiac anatomy compared with transthoracic echocardiography. TEE is performed by the introduction of a probe attached to a fiberoptic endoscope into the esophagus. Caused by the position close to the heart e.g., clot finding and the view of the mitral valve are improved.

Indications:
The piezoelectric crystal creating the acoustic power is mounted on the gastroscope that must be swallowed by the patient. This endoscopic transducer is miniaturized to approximately the size of a fingernail. Usually the probe is in place for an average of 15 minutes, to numb the surface a topical anesthetic is sprayed into the throat, in addition a conscious sedation is recommended.

See also Myocardial Contrast Echocardiography, Stress Echocardiogram, M-Mode Echocardiography, Contrast Enhanced Ultrasound and Vascular Ultrasound Contrast Agents.

(TRUS) Transrectal sonography (also called transrectal ultrasonography, transrectal echography (TRE), endorectal ultrasound (ERUS or EUS)) is an ultrasound procedure used to examine the prostate gland, the rectum or bladder.
A small, lubricated transducer placed into the rectum releases sound waves, which create echoes as they enter the region of interest. A computer creates a picture called a sonogram.
TRUS is commonly used for guidance during a prostate needle biopsy and may be used to deliver brachytherapy and monitor cancer treatment. Transrectal ultrasonography detects enlargement, tumors and other abnormalities of the prostate, rectal polyps, rectal cancer, perianal infection, and sphincter muscle injuries. TRUS is also performed on male patients with infertility to view the prostate and surrounding structures and on patients with suspected bladder conditions or disease to view the bladder.

See also Transurethral Sonography, Endoscopic Ultrasound, Pelvic Ultrasound, Rectal Probe, Biplane Probe, Endocavitary Echography and High Intensity Focused Ultrasound.