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Ever wonder what an e*CRO is? Here’s a PDF file describing what an e*CRO is and does.

Click here to download the file in .zip format

Email the answers to Joyce. We’ll pick a winner among correct entries. There’s no prize this week other than the fact that you’ll be the very first winner.

Aphrodisiacs are based more on cultural myths than fact. Throughout history, certain foods, beverages, drugs, and chemicals were hoped to have aphrodisiac powers. Named after Aphrodite, the 1) ___ goddess of love, beauty, and fertility, aphrodisiacs are substances that supposedly elicit desire, arousal, and enhance drive and performance. The most famous reputed aphrodisiac of all is 2) ___ ___, made from ground-up 3) ___, Lytta vesicatoria. Its active ingredient, cantharidin, irritates the bladder and urethra, causing increased 4) ___ flow to the genitals and sensations of warmth there. It may lead to abnormally prolonged or constant 5) ___. Spanish Fly can be poisonous or even fatal with prolonged use. Consider: moderate amounts of red wine, [with antioxidant effects of raising 6) ___ and preventing blood clotting in vessels] and 9 chocolate [antioxidant] kisses equaling 230 calories [sugar free, less calories]. If the last two aphrodisiacs, lead to physical loving, the calories burned, would be 150-200 calories per half hour, which in turn leads to a deeper more rejuvenative 7) ___. HAPPY VALENTINE’S DAY!!!

Section 505 of the Food Drug and Cosmetic Act (the Act) describes three types of new drug applications: (1) an application that contains full reports of investigations of safety and effectiveness (section 505(b)(1)); (2) an application that contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference (section 505(b)(2)); and (3) an application that contains information to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics, and intended use, among other things, to a previously approved product (section 505(j)). Section 505(b)(2) was added to the Act by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This provision expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant. Sections 505(b)(2) and (j) together replaced FDA’s paper NDA policy, which had permitted an applicant to rely on studies published in the scientific literature to demonstrate the safety and effectiveness of duplicates of certain post-1962 pioneer drug products (see 46 FR 27396, May 19, 1981). Enactment of the generic drug approval provision of the Hatch-Waxman Amendments ended the need for approvals of duplicate drugs through the paper NDA process by permitting approval under 505(j) of duplicates of approved drugs (listed drugs) on the basis of chemistry and bioequivalence data, without the need for evidence from literature of effectiveness and safety. Section 505(b)(2) permits approval of applications other than those for duplicate products and permits reliance for such approvals on literature or on an Agency finding of safety and/or effectiveness for an approved drug product.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

According to an article published in the British Medical Journal (2007;334:245-248), a study was performed to examine the relation between IQ in childhood and vegetarianism in adulthood. The investigation was a prospective cohort study in which IQ was assessed by tests of mental ability at age 10 years and vegetarianism by self-report at age 30 years. Study participants included 8,170 men and women aged 30 years, who took part in the 1970 British cohort study, a national birth cohort. The main outcome measures were self-reported vegetarianism and type of diet followed. Results showed that 366 (4.5%) persons said they were vegetarian, although 123 (33.6%) admitted eating fish or chicken. Vegetarians were more likely to be female, to be of higher social class (both in childhood and currently), and to have attained higher academic or vocational qualifications. Interestingly, these socioeconomic advantages were not reflected in their income. Higher IQ at age 10 years was associated with an increased likelihood of being vegetarian at age 30 (odds ratio (OR) for one standard deviation increase in childhood IQ score 1.38). IQ remained a statistically significant predictor of being vegetarian as an adult after adjustment for social class (both in childhood and currently), academic or vocational qualifications, and gender (OR = 1.20). Exclusion of those who said they were vegetarian but ate fish or chicken had little effect on the strength of this association. According to the authors, higher scores for IQ in childhood are associated with an increased likelihood of being a vegetarian as an adult.

We only sell software which we develop ourselves and use in our drug and device development business. This is one of the ways we assure quality and are different from other CROs. Our Flagship Software products are Target e*CRF®, Target Document® and Target Encoder™. For more information, please contact Dr. Jules T. Mitchel.

Target Health is pleased to announce Target Document® is now ready for formal release. Several of our clients have seen it, as well as several CROs. Target Document is 21 CRF Part 11 compliant and also complies with ISO standards. Special introductory prices available. We have a USER FRIENDLY interface and workflow. Key features include:

1. Web-based
2. Works off a browser
3. 21 CFR compliant
4. eSignatures
5. Unique access control to projects, folders
6. One click user management
7. Advanced administrative functions
8. Many more

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