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However, because orphan drugs are developed for rare, often life-threatening dis eases, including certain forms of cancer and genetic disorders, the review process is usually shorter and less comprehensive than the review of a typical drug According to the FDA, as of the rst quarter of 2003, over 1,000 orphan products have been designated and over 220 have been approved for marketing Orphan drug programs, such as Tin Mesopor phyrin and Heme Therapy in Acute Porphyria have been enacted by the EU, Japanese, and Australian governments A list of orphan drug pro grams funded by the FDA can be found on the agency s Web site: http://wwwfdagov/orphan/grants/awardedhtm Pediatric exclusivity is one way to obtain six months of added patent protection for a drug Most drugs undergo clinical trials with adult sub jects.

where a~l'vns and a~N)s are the TE and TM scattered wave expansion coefficients and the vector cylinderical waves M 11, and N 11, are defined in 1, Section 4.2 of Volume I. The internal field is given by (9.3.4) where c~M) and

c}['l)

k~ -

(9.3.5)

6 Use the tree view to navigate to the class you wish to use for object binding The tree view only lists the classes in the Windows Application project and classes in any component referenced by the Windows Application project If you already have a reference to your business object Class Library component, the component appears in the Data Source Con guration Wizard, as shown later in Figure 74, and you can skip to step 9 Otherwise, you can add a reference using the following steps 7 Click the Add Reference button The Add Reference dialog appears, as shown in Figure 73

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with kp = wVIJEp. Because of phase matching, both the scattered field and the internal field have the same exp( ikizz) dependence.

From 1, Section 6.2 of Volume I, there are four equations relating the scattered field coefficients a~M)s, a~N)s and the internal field coefficients M ), c~N)to the incident field coefficients a~M), a~N). From equations (1.6.58)-(1.6.61) of Volume I,

- k a(M) J' (k a) - k a(M)s H(l)'(k a) - nkiz a(N) J n (k' a) zp n n zp zp n n zp ka n zp _ nk iz (N)sH(l)(k' ) ka an n zpa - - k ippC (M)' (k ippa ) - -k- cn I (kippa ) nk iz (N) n n In pa k2 ~J (k a)a(N) k n zp n k + ~H(1)(k'zp a)a(N)s k n n

(9.3.6)

Figure 73 Select the Projects tab in the Add Reference dialog to display all the other projects in the current solution 8 In the Add Reference dialog, select the component containing the class for the data source, and click OK The classes in the referenced project are then added to the Data Source Con guration Wizard, as shown in Figure 74 9 Select the desired class, and click Finish The object data source for the selected class is added to the Data Sources window, as shown in Figure 75

However, for drugs that have application in pediatric populations, and in which the clinical trials consider pediatric uses, it may be possible to qualify for pediatric exclusivity Discovering a new indication for an existing blockbuster drug, while not as good as discovering a completely new drug, can be worth billions For example, Minoxidil was originally introduced by UpJohn in the late 1970s as an oral antihypertension medication, and later used as a topical treatment for male pattern baldness In the late 1990s, the cholesterollowering drug Pravachol by Bristol-Myers Squibb was approved by the FDA for a new indication reducing the risk of a transient ischemic at tack (a miniature stroke) and a recurrent attack in patients who have had a heart attack.

(9.3.7)

k [-k.zp a(N)}' (k a) - k a(N)s H(l)'(k a) n n zp zp n n zp _ nkiz (M)J (k' ) _ nk iz (M)sH(l)(k )] ka an n zpa ka an n zpa (N) , (k ( ) nk iz (M) )] = kp [ -kippCn I n ippa - kpa Cn I n kippa

(9.3.8)

kTpJn(kipa)a~M) + kTpH~l)(kipa)a~M)s = kTppJn(kipa)c~M)

NOTE: The Data Sources window lists only class properties that are defined with a Property statement

(9.3.9)

Eliminating the scattered field coefficients gives the equations relating the internal field coefficients to the incident field coefficients. From Volume I, (1.6.62) to (1.2.67), we have

(9.3.10) (9.3.11)

(9.3.12) (9.3.13) (9.3.14)

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