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Introduction

There are 3 zones in English writing: Upper (l,h,t,b,etc.), Middle (a,m,n,o,u,e,i,s,v,c,r,w,x,z), and Lower (f,g,j,p,y). The middle zone dominates handwritten expression accounting for over 80 per cent of zonal space. It’s the core of the personality expression. The “accepted” standard of 1/8th (.125) inch in some literature and 3 mm in other literature was questioned. A search carried out by the author found no supporting statistics to substantiate that concept. Therefore, a research study was initiated to assess an average (or standard) middle zone size, in general.

Methodology

Two studies were conduct

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ed twenty years apart. The information was taken from continuously measured MZ data (normally performed) over that period of time. In other words, all samples had MZ measurements taken for that 20 years with data stored or recorded.

The first study was performed during the years 1978-1979 and involved 500 handwriting specimens. These samples were selected from individuals of 19 years of age and older. There were 250 samples each of males and females. Specimens were not used if the handwriting reflected aging or infirmities. A calibrated, documented caliper capable of measuring in increments of .0005 inch, traceable to t

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

he United States national bureau of standards, NIST, was used in the measurement process along with a scientific calculator. Five measurements were made on each of the 500 samples. The measurements were made in the following manner: one from the top of the display, three from the middle of the display and a final one from the end of the display. These measurements were tediously taken at random and recorded. Measurements were made of the down strokes of Middle Zone letters including the slant - not just the vertical height. This must be done because the full length of the down stroke represents the writer and with a 30

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

-degree slant vertical measurement would be erroneous by 100%. A total of 2,500 measurements were recorded.

The second study was performed during the years 1999-2000 and involved 231 handwriting specimens. These samples came from individuals located throughout the United States of America and were received by way of conducting handwriting analyses for either business or personal purposes. There was an approximately equal distribution of males and females. This time a digital, calibrated caliper, connected to a statistical mini-computer, was utilized. This enabled the author to increase ease of sampling in very accurate

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

increments of .0005 inch and traceable to NIST with calibrated, documented instrumentation. This afforded quick and numerous measurements. Over 60 random measurements were made on each sample. Calculated as closely as possible, a total of 13,860 measurements were recorded.

Results

The results tend to be skewed significantly below the generally accepted standards of 1/8th of an inch or 3-mm. Table 1 gives the results from study one and Table 2 gives the results from the second study. The correlation (r) of the two studies is .936, which is extremely high and tends to suggest the consistency between both studies. In th

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e first study, 86.2% of observations were below 1/8th (.125) inch and, in the second study, 78% were below 1/8th inch. Furthermore, the percent below 3-mm (.1182 inch) in both studies was 82% and 72.2%, time respective.

Other results:

- The medians were .100 inch and .094 inch. Again, tending well below 3 mm.
- The standard deviations were exactly the same to 4 places but not beyond. This seemed highly improbable but was checked.
- The modes were less than .100 inch with one exactly the same (.086 inch).

Table 1 1978-1979 Study Results
Intervals for Middle Zone Size in Inches (in) Frequency of Measureme

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

nt in each Interval Percent of Frequency in each Interval
.039 or Less 0 0
.040-.049 5 1.0
.050-.059 17 3.4
.060-.069 27 5.4
.070-.079 66 13.2
.080-.089 92 18.4
.090-.099 86 17.2
.100-.109 63 12.6
.110-.119 57 11.4
.120-.129 35 7.0
.130-.139 20 4.0
.140-.149 13 2.6
.150-.159 8 1.6
.160-.169 2 .4
.170+ 9 1.8

500 100

Total Samples (N)
Average .098511
Standard Deviation .0264237
Variance .0006968
Median .094
Mode(s) (14 each) .086 & .094
Correlation to “99-‘00 Study (r) = .936
Number of

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

measures 500 x 5 = 2500

Table 2 - 1999-2000 Study Results
Intervals for Middle Zone Size in Inches (in) Frequency in each Interval Percent in each Interval Standard Deviation Array Frequency

% of each Standard Deviation
.039 or Less 0 0 .005 1 .416
.040-.049 1 .43 .006 0 0
.050-.059 3 1.29 .007 0 0
.060-.069 8 3.46 .008 3 1.250
.070-.079 23 9.95 .009 2 .833
.080-.089 38 16.45 .010 5 2.083
.090-.099 35 15.15 .011 6 2.500
.100-.109 37 16.01 .012 16 6.666
.110-.119 22 9.52 .013 15 6.250
.120-.129 23 9.95 .014 19 7.916
.130-.139 13 5.62 .015 18 7.500

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

br> .140-.149 9 3.89 .016 23 9.583
.150-.159 6 2.59 .017 11 4.583
.160-.169 6 2.59 .018 15 6.250
.170+ 7 3.03 .019 10 4.166

.020 14 5.833
Total smp (N) 231* 99.93 .021 16 6.666
Average .10451 .022 3 1.250
Standard Dev. .02644 .023 14 5.833
Median .100 .024 3 1.250
Mode (7) .086 .025 12 5.000
Correlate to .026 9 3.750
“78-“79 Study .027 3 1.250
(r) = .936 .028 3 1.250
Number meas. 231x60 = .029 0

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

0
13,860 .030 1 .416

.031 2 .833

.032 3 1.250

.033 4 1.666

.034 1 .416

.035 1 .416

.036 4 1.666

.037 0 0

.038 0 0

.039 1 .416

.040 1 .416

.050+ 1 .416

Totals 240* 99.989

Discussion and Conclusion

Although these studies were conducted 21 yea

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

rs apart they demonstrate a correlation to size distribution of (r) .936. Aside from the measurements documented in this report, over 600,000 individual MZ measurements were made by the author since 1977 as standard practice on all analyses. Those measurements continue to reflect the results of these studies.

The overall conclusion tends to indicate that the standard (or average MZ size) is significantly less than the arbitrary 3 mm. The author has used the .098511 inch standard as the “fulcrum” for assessing middle zone size relationships. The studies tend to indicate repeatability, which is the basis for scientific i

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

nvestigation. Similar studies in every country are encouraged to establish a world standard or individual national standards.

A further observation

Additionally, the author has been intrigued by the possibility (and, in the absence of any publication) of a polar-concept to handwriting/printing meaning that there are only two fundamental elements that create any handwriting/printing. We see this binary concept throughout the Universe. To this end, a conclusion has been determined: Pressure and Speed. These are the two essential elements constituting the creation of all writing/printing. Both range from a possible zero

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

value to the capacity of the writer. Some basic explanations are warranted since questions are certain to arise.

A dot or period is the simplest form of speed (moving down) and pressure (against the resistance of the surface). If it is true for a dot then it is true for all writing. Space is the absence of pressure yet incorporates speed for spatial adjustment. Although there will be some controversy, it is the author’s belief the conclusion has merit, however, other observations are welcome.

Observations on Study One of MZ Average Size Measurements

Individual Standard Deviations were not recorded in study number one

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

.

1. More than 86% (86.2%) are less than the generally accepted “standard” of 1/8th of an inch (.125”) or 3.1725 mm.
2. Only 7% are within the “standard” .120”-.130”.
3. Correlation with a similar study (“98-’00) 21 years later is extremely high at r = .936.
4. Confidence limits at 1 SD range from .072” to .124”. 66% confidence, results are in this range.
5. Confidence limits at 2 SD range from .045” to .151”. 95% confidence, results are in this range.
6. Confidence limits at 3 SD range from .019” to .177”. 99% confidence, results are in this range.
7. The average was calculated at .

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

098511 inch well, below the 1/8th inch generally accepted “standard”.
8. The standard deviation was calculated at .0264237 inch.
9. The median was .094 inch.
10. The mode(s) were (14 each) .086 inch and .094 inch

Observations on Study Two of MZ Average Size Measurements

1. More than 77% (77.9%) are less than the generally accepted “standard” of 1/8th of an inch (.125”) or 3.1725 mm.
2. Only 9.9% within current accepted ‘standard’ .120”-.130”.
3. Correlation with a similar study (“78-’79) 21 years later is extremely high at r =.936.
4. Confidence limits at 1 SD range from .0780” to .1309”.

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

66% confidence results are in this range.
5. Confidence limits at 2 SD range from .0516” to .1573”. 95% confidence results are in this range.
6. Confidence limits at 3 SD range from .0252” to .1838”. 99% confidence results are in this range.
7. The average was calculated at .10451 inch. Well below the 1/8th inch generally accepted “standard”.
8. The standard deviation was calculated at .02644 inch.
9. The median was .100 inch.
10. The mode was .086 inch (7 total)
11. * Recording errors account for differences but have virtually no effect on results.

Bibliography

Writings, Ins

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ruction, Scoring, P Velasco, 1990, self published Cluster Indicators of Handwriting Elements, J. Cammarata, 1984, Self-Published
Experiments with Handwriting, Robert Saudek, 1929, William Morrow & Co., NY
The Psychology of Handwriting, Nadya Olyanova, 1960, Sterling Publishing, NY
Studies in Expressive Movement, GW Allport & PE Vernon, 1933, Macmillan, NY
Diagrams of the Unconscious, W Wolff, 1948, Grune & Stratton, NY
The Psychology of Handwriting, Robert Saudek, 1925, Allen & Unwin, London
*Handwriting: A Key to Personality, K Roman, 1975, Noonday Press, NY, page 147.
Thoughts and wri

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

tings of D Anthony & F Anthony, self published
*Handwriting, An Analysis through Its Symbolism, R Hearns, Vantage, NY, page 36.
Handwriting and Character, D Lucas, 1923, McKay Company, Philadelphia, PA
The Science of Handwriting Analysis, B Rosen, 1965, Bonanza Books, NY
*Analysis of Handwriting, H Jacoby, 1939, Allen & Unwin, London
Handwriting Analysis, TS Lewinson & J Zubin, 1942, Kings Crown Press, NY
Personality in Handwriting, AO Mendel, 1947, Stephen Daye Press, NY
Handwriting Analysis, U Sonnemann, 1950, Allen & Unwin, London
Handwriting, A Key to Successful Living, HO Teltsch

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

er, 1942, GP Putnam, NY
*The Key to Handwriting Analysis, I Marcuse, 1962, Rolton House, NY, page 39.
Trattato…Scrittore, C Baldi, 1620, Bologna, Italy
Handschrift und Charakter, L Klages, 1940, Leipzig
Applied Graphology, I Marcuse, 1946, Macoy, NY
Handwriting, A Personality Projection, F Victor, 1945, Thomas, NY
*Graphology Handbook, C Casewit, 1980, Para Research, MA, page 39.
The Principle Trait Clusters for Describing Personality, R B Cattel, Psychological Bulletin, 42:129-161, 1945
*Handwriting Analysis, Thea Stein Lewinson, 1967, page 36, University Microfilms, Inc., Ann Arbor

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

, MI.
*Handwriting & Personality, Ann Mahony, 1989, page 63.
*Write What’s Wrong, Dr. Claude Santoy, 1992, page 12.
*Practical Character Analysis from Handwriting, Albert J. Smith, 1920, London, page11.
*What Handwriting Indicates, John Rexford, 1904, page 11.
*Handwriting Analysis, Dorothy Sara, 1967, page 98.
*The Elements of Graphology, Barry Branson, 1995, page 17.
*Handwriting as an Index to Character, very old book, no author or date of publication, London, page 3.

NOTE: An asterisk (*) denotes references stating either 1/8th inch or 3mm as the normal middle zone size or height

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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