w w w . a m t r x . c o m

DESCRIPTIONTrans-D Tropin® is formulated to provide a high potency,convenient, growth hormone releasing hormone analogcombinant administered by trans-dermal application. Eachdrop delivers approximately 485 ug (micrograms) of activeingredients.

FUNCTIONSThe active ingredients in Trans-D Tropin® are Amino acidsincluding alanine, arginine, glutamine, glycine, histidine,isoleucine, leucine, lysine, phenylalanine, proline, serine,threonine, tryptophan, tyrosine, and valine, germaben,propylene glycol, sorbitol, almond oil and/or apricot oil,carnation/jasmine fragrance, sorbitol, distilled water, in acreme’ base with EVITO™ (proprietary formula consistingof oleic acid, linoleic acid, gamma linolenic acid, stearic acid,hexadecenoic acid, palmitic acid, eicosenoic acid,docosenoic acid, tetracosenoic acid, eicosapentaenoic acid,docosahexaenoic acid, myristic acid, lauric acid, caprylicacid, capric acid, a, b, g & d tocopherols, tocotrieols, andnaturally occurring antioxidants and bioflavinoids).

ACTIONS AND PHARMACOLOGY (Function)Trans-D Tropin® is a unique formulation of natural (L) aminoacids which act as primary and secondary messengers inthe human body for the production of growth hormone.It is composed of four unique condensates, which elicit adirect and indirect cascade of immediate physiological andprogrammed responses. Since Trans-D Tropin® is a growthhormone releasing hormone analog acting only as amessenger and is not direct administration of exogenousgrowth hormone, all responses are limited to normalphysiological response within biological limits.

BIOLOGICAL PROGRAMMING RESPONSEUpon administration of Trans-D Tropin®, endogenousgrowth hormone levels measured via radio-immunoassayhave significantly increased. The response is not onlyimmediate, but also re-establishes circadian growthhormone release rhythm (program) back to a youthfullevel. Responses measuring over 1500 % increase havebeen measured and are not unusual.

The greatest response observed with Trans-D Tropin® isin the middle aged population between the ages of 30 to60 years, while the greatest efficacy is noted in the elderly.Normal responses include but are not limited to anincrease in muscle strength, stamina, endurance, libido,cognative skills, and cardiovascular strength. Trans-DTropin® also moderates glucose and insulin levels,mineralcortocorticoids, lipids, IGF-1, IGF Binding Protein3 levels and appears to increase Pregnenolone conversionto Progesterone.

When administering Trans-D Tropin®, one should increasevitamin and mineral intake and increase protein intake.This increase is necessary because of the systemic up-regulation of the entire physiological system. Interestingly,if the individual utilizing Trans-D Tropin® requires rest andrecuperation but has neglected to fulfill this need, Trans-DTropin® will down regulate unnecessary systems and forcethe individual into a down-regulation up to 48 hours, whileup-regulating required reparative systems. This is usuallymanifested as a greater requirement for sleep in the firstweek of usage.

INDICATIONS AND USAGETrans-D Tropin® is indicated in any patient where anincrease of endogenous GH is desired, without theassociated risks and complications noted with injectibleGH therapy.

DOSAGE AND ADMINISTRATIONTrans-D Tropin® is administered daily on an area of thebody with minimal subcutaneous tissue in a capillary denseregion with a high vascular supply. The most commonarea, for example, would be the volar aspect of the forearm.Apply several drops and smooth into skin for absorption.Normal dosage is usually applied in 3 separate doses duringmorning, early afternoon and prior to bedtime.Theoretically, for the best response, apply Trans-D Tropin®

prior to eating on an empty stomach.

PROTOCOLNo. 99

Trans-D Tropin®

NDC# 65448-2115-1

TM

99-2

R E F E R E N C E S

w w w . a m t r x . c o m

Patient Protocol for Trans-D Tropin®

The patient should implement the followingnecessary guidelines in order to get theoptimum results:

q Apply Trans-D Tropin® to the inside ofeach forearm and rub forearms together.Try not to use your fingers to spreadTrans-D Tropin®. Trans-D Tropin® istransdermal, i.e. enters through the skin.It should be applied to an area wherethere is minimal fat with the highest bloodsupply. The inside of the forearms are thebest since the skin is very thin and doesn’tslow down the absorption of Trans-DTropin®. The inside aspects of the thighsas well as the neck area can also be usedif necessary.

q Shake the bottle well before each use.Standard Protocol: Apply 15 drops (0.5cc) of Trans-D Tropin®‚ to the inside ofeach forearm and rub arms together.Apply the above amount three times aday around 7:30 am, 4:30 pm and atbedtime. Once rubbed in completely, waita few minutes before allowing yourforearms to get wet. You may get in ashower or a pool 5 minutes after theapplication has been absorbed. AthleticProtocol: Apply 11 drops (just under 0.4cc) of Trans-D Tropin® four times daily ataround 7:30am, 11:00 am, 4:30 pm and atbedtime per the standard protocol above.Above Age 65 Protocol: Apply 20 drops(0.7 cc) of Trans-D Tropin® three timesdaily as per the standard protocol above.

q Trans-D Tropin® should be kept out ofextreme temperatures, especially heat.Although Trans-D Tropin® is very stablein normal temperatures, extreme heat hasthe potential of denaturing the uniquepolypeptide complexes and rendering thebottle ineffective. Room temperature isoptimum. If Trans-D Tropin® becomesfrozen, do not thaw it rapidly. Do not usea microwave. Place bottle at roomtemperature and allow to slowly thaw.

q Use 5 days per week, taking two days offeach week. Follow this cycle for six toeight weeks, then discontinue use for oneto two weeks. For explanation of whythis is recommended, please refer to thedouble blind study on Trans-D Tropin®.Some individuals may feel bad during the

2 week break. For those individuals, if theychoose, they may continue on Trans-DTropin®‚ during the scheduled two weekoff period. However, the 2 week off periodis recommended to maximize the effectsof Trans-D Tropin®.

q You must exercise to maximize the resultsof Trans-D Tropin®. Remember, Trans-DTropin® is NOT GH. Trans-D Tropin® isnaturally mimicking the action of GHRH,which is to potentiate endogenous(produced by your own body) GH. So itis necessary to exercise in order to getthe maximum benefits.

q If you are an athlete, you will notice howquickly your performance will increase,usually within the first 72 hours. Inaddition, recovery time is also decreasedsignificantly. However the tendency is toover train when on Trans-D Tropin®.Remember, the body grows during theresting phase. So leave adequate time foryour body to rest and recover. Althoughyou will find yourself not needing as muchrest, your body still requires it. Don’tover train.

q Do not suppress your cravings forprotein. If you have an intense desire toeat something that you don’t usually eat,especially protein, do not try and suppressit. Your body is telling you it is lackingsomething. It needs this essentialsubstance to continue the rebuildingprocess. Trans-D Tropin®‚ acts as a“general contractor”. It masterminds thechanges. But just as a general contractorneeds bricks, wood, nails, and other rawmaterials necessary to build a house,Trans-D Tropin®‚ needs to have the rawmaterials supplied that are necessary torebuild your body.

q Don’t be surprised if your consumptionof water and frequency of urinationincreases. Water is the largest substratein our body and as the physiologicalparameters shift to a younger state, theincrease in metabolic reactions willincrease the need for water. As you startto reduce body fat, your waterrequirements will also increasesubstantially and facilitate further loss ofbody fat. Drink at least 2/3rds your bodyweight in ounces of water daily. Thus, if180 lbs, drink 120 oz.

Rattan SI: Is gene therapy for agingpossible? Indian Journal ofExperimental Biology 1998 March;36(3): 233-236.

Hakkaart-Van RL, Roijen L, et al: Theburden of illness of hypo-pituitaryadults with growth hormonedeficiency. Pharmacoeconomics 1998October; 14(4): 395-403.

Barry MC, Mealy K, et al: Nutritional,respiratory, and psychological effectsof recombinant human growthhormone in patients undergoingabdominal aortic aneurysm repair.Journal of Parenteral and EnteralNutrition 1999 May-June; 23(3): 128-135.

Hendrix DK, Klien TE, Kuntz ID:Macromolecular docking of a three-body system: the recognition ofhuman growth hormone by itsreceptor. Protein Science 1999 May;8(5): 1010-1022.

Marcell TJ, Wiswell RA, Hawkins SA, etal: Age-related blunting of growthhormone secretion during exercisemay not be soley due to increasedsomatostatin tone. Metabolism 1999May; 48(5): 665-670.

Giusti M, Marini G, Sessarego P, et al:Effect of cholinergic tone on GHRHinduced secretion of growthhormone in normal aging. Aging 1992September;4(3): 231-237.

Giusti M, Marini G, Sessarego P, et al: GHsecretion in aging. Effect ofpyridostigmine on growth hormoneresponsiveness to growth hormone-releasing hormone. Recenti ProgressMedicine 1991 December; 82(12):665-668.

Buttar RA, Viktora DC, Quinn ME.Accelerated and efficacious resultsusing variable somatotroph andhypothalamotroph specific poly-peptide combinants utilizing a trans-dermal delivery mechanism (TD-GHRH-A) as an alternative torecombinant human growth hormoneinjection therapy. Journal of IntegrativeMedicine 2000;4:51-61.

Buttar RA, October 2000 ConferenceReport for the American College forAdvancement in Medicine, reportedby Ivy Greenwell, reporter forLifeExtension Magazine, February2001.

Buttar RA, Halpner A. The impact ofessential fatty acids on the agingprocess. Editor : Ghen MJ. TheAdvanced Guide to Longevity Medicine.IMPAKT Communications, Inc; 2001:221-237.

99-3

R E F E R E N C E S

w w w . a m t r x . c o m

q Sleep is one of the first things affected.Trans-D Tropin® has significantly improvedthe quality of sleep for people with sleepdisturbances. Furthermore, the amountof sleep needed is significantly reducedwith patients experiencing deeper sleepwith more vivid dreams, indicating REM(Rapid Eye Movement) sleep hasincreased. REM sleep is the most restfulcomponent of sleep. For people sufferingfrom insomnia, Trans-D Tropin® improvesthe ability to fall asleep. However, peoplewho normally fall asleep immediately seemto experience a delay in onset of sleepafter initiating treatment. It takes abouttwo weeks to normalize this cycle beforesleep onset returns to normal.

q If you are obese, you will note a decreasein weight over time. However, if you arenot obese, you will probably gain a fewpounds. Lean body mass (muscle)increases and weighs more than the bodyfat that you are loosing. Remember,muscle weighs more than fat. Clothes willfit better and you will look as if you havelost weight, although you will have gained(muscle) weight. Most people also notechanges in facial and body contour. Leanbody mass increases in obese patients aswell but the obese patients loose fargreater body fat and therefore, will see adrop in overall weight over time.

q Contraindications to Trans-D Tropin® useare listed on each bottle. Do not useTrans-D Tropin® if you’re pregnant, have apituitary tumor (IGF-1 or prolactin testwill rule out a pituitary tumor) or areunder the age of 21.

There are two current protocols that workoptimally. Sedentary patients have noticedchanges within the first seven daysgenerally. Your doctor will tell you whichprotocol is best suited for you. If you donot see significant changes within twoweeks, especially if you are over the ageof 65, let your doctor know so they canmake the necessary changes. But, DONOT increase dosage yourself.

As with any form of treatment, you must givethe treatment a chance to work optimally.For example, if you are 40, remember that ittook 40 years for you to get to this point in

your life. Despite the great majority ofpatients noticing some positive changerelatively quickly, you should continuetreatment with Trans-D Tropin®‚ for at leastthree months before determining theeffectiveness of the treatments.

Trans-D Tropin®‚ results in a direct increasein endogenous growth hormone, whichresults in an upregulation of virtually allhormones. Please refer to the studiesshowing changes in testosterone, cortisol,glucose, etc. with the use of Trans-D Tropin®.Use of a melatonin, DHEA and other varioushormones is not advised while taking Trans-D Tropin®. It may prevent you from gettingoptimal results due to disruption of theinhibitory feed back looks. The body knowswhat it needs and it definitely does NOT needto have the delicate hormonal balancedisrupted. So it’s better to just leave theindividual hormone levels alone. With theexception of thyroid supplementation (ifhypothyroid) or the use of progesterone, noother hormones are necessary when usingTrans-D Tropin®.

People showing minimal response to Trans-D Tropin®‚ are the ones on anxiolytics (Xanax,Ativan, etc,) anti-depressants (Zoloft, Paxil,Prozac, Amitryptalene, etc,) and stimulants(amphetamines). Also, smokers don’t get asgood response. Chronically ill people seemto show a negative change initially, similar toa detoxification treatment course, but withintwo or three weeks, they also show significantpositive changes. So be prepared for somenegative changes initially, especially if you area patient with a chronic health problem. Ifyou have a liver or a gastro-intestinalimbalance or a heavy-metal toxicity, you maynot see significant results. Ask your doctorabout treating these imbalances first beforeyou start your anti-aging therapy with Trans-D Tropin®.

If you are currently using injection treatmentsor secretagogue treatments and wish tochange to Trans-D Tropin®, therecommendation is to stop the originaltreatments, wait at least two to four weeks,and then start on Trans-D Tropin®. This allowsfor a wash out period. Also, don’t use Trans-D Tropin®‚ with GH injections. It can be

Ghigo E, Goffi S, Arvat E, et al:Pyridostigmine partially restores theGH responsiveness to GHRH innormal aging. Acta Endocrinology(Copenh) 1990 August; 123(2): 169-73.

Jaffe CA, DeMott-Friberg R, et al:Endogenous GHRH is required forGH responses to pharmacologicalstimuli. Journal of Clinical Investigation1996 February 15;97(4): 934-940.

Pyka G, Wiswell RA, Marcus R: Age-dependent effect of resistanceexercise on growth hormonesecretion in people. Journal of ClinicalEndocrinology and Metabolism 1992August; 75(2): 404-407.

Coiro V, Volpi R, Capretti L, et al: Age-dependent decrease in the GHresponse to GHRH in normallycycling women. Fertility, Sterility 1996August; 66(2): 230-234.

Spoudeas HA, Matthews DR, Brook CG,et al: The effect of changingsomatostatin tone on the pituitaryGH and TSH responses to theirrespective releasing factor stimuli.Journal of Clinical Endocrinology andMetabolism 1992 August; 75(2): 453-458.

Kelijman M, Frohman LA: Impairedinhibitory effects of somatostatin onGHRH stimulation of GH secretionafter short term infusion. Journal ofClinical Endocrinology and Metabolism1990 July; 71(1): 157-163.

Giustina A, Bossoni S, Bodini C, et al: Therole of cholinergic tone in modulatingthe GH response to GHRH in normalman. Metabolism 1991 May; 40(5): 519-523.

Ross RJ, Tsagarakis S, Grossman A, et al:GH feedback occurs throughmodulation of hypothalamicsomatostatin under cholinergiccontrol: studies with pyridostigmineand GHRH. Clinical Endocrinology(Oxf) 1987 December; 27(6): 727-733.

Pontiroli AE, Lanzi R, Monti LD, et al: GHautofeedback on GH response toGHRH. Role of free fatty acids andsomatostatin. Journal of ClinicalEndocrinology and Metabolism 1991February; 72(2): 492-495.

Vance ML, Kaiser DL, et al: Dual effectsof GHRH infusion in normal men:somatotroph desensitization andincrease in releasable GH. Journal ofClinical Endocrinology and Metabolism1986 March; 62(3): 591-594.

Jaffe CA, Ho PJ, et al: Effects of aprolonged GH-releasing peptide

99-4

R E F E R E N C E S

w w w . a m t r x . c o m

dangerous. Some physicians recommendalternating between Trans-D Tropin®‚ and GHinjections. However, do not use them bothconcurrently.

Please remember that it took years for yourbody to get where it is now. Although themajority of patients notice changes within thefirst few weeks, it may take a few MONTHSto get the results you expect. Even AFTERyou stop noticing changes externally(outside), Trans-D Tropin®‚ continues to workinternally. Consistency is paramount.

WARNINGSKeep your bottle of Trans-D Tropin®‚ out ofextreme temperatures especially heat. Keepit out of the reach of children. Do not use ifyou are pregnant, under the age of 18 or areactively being treated for a pituitary cancer.Although safe, it may be better not to use inlactating females.

CONTRAINDICATIONSNo known sensitivity to active or inactiveingredients.Pituitary adenoma or high prolactin.

DRUG INTERACTIONSNo drug interactions have been assessed.

OVERDOSAGEDiscontinue use for two days and return tooriginal schedule.

NOTE: There is not a direct dose dependentrelationship. The dose relationship is athreshold dependent function or a stepfunction: Below the threshold, no responseis elicited; Upon attaining the threshold dose,the message is recognized and fully integrated;Upon additional increases in dosage, littleadditional increase in response is noted.However, when a great excess is administered,the system negates the response and returnsto a minimal response as a result of thenegative, inhibitory feed back loop beinginitiated via somatostatin.

Packaging: 1 oz bottleStorage: 15-30 deg C (59-86 deg F)Manufacturer: V-SAB Medical Labs, Inc.Made in U.S.A.

Further Editorial Information ofInterestThe physiological approach utilized toformulate Trans-D Tropin®‚ is vital tounderstand the goal of therapy. Rather thanemulate the desired end product with asynthetic substance, the goal was to identifythe messenger that would allow the bodyto increase the desired end product byincreasing the body’s own production. Onceidentified, the messenger was mimicked toincrease the desired end productendogenously.

In the case of Trans-D Tropin®‚ this approachallowed for the identification of the varioushypothalamic specific polypeptides whichform GHRH. GHRH is responsible for therelease of growth hormone from thepituitary. Thus, Trans-D Tropin®‚ (varioushypothalamic specific polypeptide analogcombinants) is a GHRH analog or mimicker,emulating the function of GHRH andresulting in an increase in the natural pulsatilerelease of endogenous GH.The sequencing technology utilized tomanufacture Trans-D Tropin®‚ is far moreadvanced than any currently available andestimated by some scientists to be 15 to 20years ahead of it’s time. Very simply, thistechnology allows for the creation of anyamino acid combinant peptide analogs. Inthis specific case, it allows for the creationof hormonal messenger analogs, mimickingthe action of the body’s own endogenoushormonal messengers. It is important torealize that simply blending amino acids orcombining amino acid stacks will notaccomplish the task achieved by Trans-DTropin®‚ (or any of the other uniquetransdermal polypeptide combinant analogsby Balance Dermaceuticals‚).

To best understand this concept, think ofyour own body’s composition. If you takethe exact chemical constituents that makeup your own body down to every singlecomponent, add the necessary amount ofwater and bring the resulting concoction upto 98.7 degrees Fahrenheit, would you havea clone of yourself? How about anotherhuman? How about anything that evenresembles life? The answer is, obviously not.

infusion on pulsatile GH secretion innormal men. Journal of ClinicalEndocrinology and Metabolism 1993December; 77(6): 1641-1647.

Martha PM Jr, Blizzard RM, et al: Apersistent pattern of varying pituitaryresponsivity to GHRH in GH-deficient children: evidencesupporting periodic somatostatinsecretion. Journal of ClinicalEndocrinology and Metabolism 1988September; 67(3): 449-454.

Khalsa, DS: Exelon: A new drug forAlzheimer’s Disease. InternationalJournal of Anti-Aging Medicine 1998 June(Premier Issue); 1(1): 54-46.

Spoudeas HA, Winrow AP, et al: Low-dose GHRH tests: a dose-responsestudy. European Journal of Endocrinology1994 September; 131(3): 238-245.

Casanueva FF, Burguera B, et al:Depending on the time ofadministration, dexamethasonepotentiates or blocks GHRH-inducedGH. Neuroendocrinology 1988 January;47(1): 46-49.

Barbarino A, Corsello SM, et al:Corticotropin-releasing hormoneinhibition of GHRH-induced GHrelease in man. Journal of ClinicalEndocrinology and Metabolism 1990November; 71(5): 1368-1374.

Giustina A, Doga M, Bodini C, et al: Acuteeffects of cortisone acetate on GHresponse to GHRH in normal adultsubjects. Acta Endocrinol (Copenh) 1990February; 122(2): 206-210.

Evans WS, Vance ML, Kaiser DL, et al:Effects of IV, SQ, and intranasaladministration of GHRH-40 onserum GH concentration in adultmen. Journal of Clinical Endocrinologyand Metabolism 1985 November;61(5): 846-850.

Gupta SK, Krishnan RR, Ellinwood EH,et al: Pharmacokinetics of GHsecretion in humans induced GHRH.Life Sciences 1990; 47(21): 1887-1893.

Vance ML, Kaiser DL, Evans WS, et al:Evidence for a limited GHRH-releasable quantity of GH: effects of6-hour infusions of GHRH on GHsecretion in normal man. Journal ofClinical Endocrinology and Metabolism1985 February; 60(2): 370-375.

Low LC: GHRH clinical studies andtherapeutic aspects.Neuroendocrinology 1991; 53 Suppl 1:37-40.

Review of Medical Physiology, 15th Edition,by Ganong, WF, Lange, J, et al.Appleton & Lange, ” 1991, Ch 14, pg

99-5

constituents of Trans-D Tropin®.Furthermore, not only do these EFAtransdermal transport delivery mechanismsallow for convenient dosing, they have alsobeen actually found to contribute tostabilizing the amino acid combinant peptideanalog structures. Not surprisingly,assimilation into the system is achievedbeyond that of other delivery mechanismsincluding other non-EFA transdermal deliverymechanisms.

For further information regardingTrans-D Tropin®, please refer to theTrans-D Tropin®‚ support packet andsearch for “The Inter-RelationshipBetween GH and IGF-1: Correlation withCancer” as published in Anti-AgingMedical Therapeutics, Volume 5.

R E F E R E N C E S

w w w . a m t r x . c o m

However, the real question that must beasked is, what makes you physically differentfrom the concoction that you just created?The answer: It’s “HOW” you were puttogether which makes you different. NOTthe ingredients! This is the reason why Trans-D Tropin®‚ and the other transdermallydelivered polypeptide combinant analogcomplexes by Balance Dermaceuticals‚ areso efficacious. It is “HOW” they are puttogether that makes them so effective.

The last key component is the deliverymechanism. A relatively uncharted area ofscience incorporates the utilization of EFAs(essential fatty acids) as a mechanical meansof therapy, such as employment in a drugdelivery system. Already, the delivery methodfor a number of unique experimentaltreatment modalities such as B Lymphocytestimulators as well as established treatmentmodalities such as growth hormone releasinghormone analogs utilizing polypeptidesynthesis technologies (Trans-D Tropin®) havebeen achieved utilizing EFAs as the mode oftransport.

The delicate nature of these polypeptidecombinant analogs renders them susceptibleto denaturing by gastrointestinal acids anddigestive enzymes as well as the fact that ourmodern day society has created atremendous vacillation in gut function andpoor gut absorption. This results inpreventing oral delivery mechanism frombeing a viable or effective option.Conventional paraenteral routes (IV, IM orSQ injections) raise the issue of compliancedue to the necessity for daily injections aswell as the concern for convenience. Thevery sensitive nature of these polypeptidecombinant structures, which result in actionsanalogous to hormones, prevents traditionaldrug delivery mechanisms from being utilized.

Utilizing specific combinations of EFAs withother carrier substances, these newpolypeptide treatment modalities now havea way of being delivered into the system in atransdermal manner without the concernsof denaturing or issues regarding compliance.Evito‘ is one such transdermal deliverymodality utilized to deliver the active

214 - 236 and Chapter 20, pages 350-352.

Mazzoccoli G, Giuliani A, Bianco G, et al:Decreased serum levels of insulin-likegrowth factor (IGF)-I in patients withlung cancer: temporal relationshipwith (GH) levels. Anticancer Research1999 March/April; 19(2B): 1397-9.

Norrelund H, Fisker S, Vahl N, et al:Evidence supporting a directsuppressive effect of growth hormoneon serum IGFBP-1 levels. GrowthHorm IGF Res (Denmark) 1999February; 9(1): 52-60.

Borges MH, Pinto AC, DiNinno FB, et. al:IGF-I levels rise and GH responsesto GHRH decrease during long-termprednisone treatment in man. Journalof Endocrinological Investigation 1999January; 22(1): 12-7.

Gelato MC: Aging and immune function:a possible role for growth hormone.Hormonal Research 1996; 45(1-2): 46-9.

Furlanetto RW: Insulin-like growth factormeasurements in the evaluation ofgrowth hormone secretion. HormonalResearch 1990;33 Suppl 4:25-30.

Kawai N, Kanzaki S, Takano-Watou S, etal: Serum free insulin-like growthfactor I (IGF-I), total IGF-I, and IGF-binding protein-3 concentrations innormal children and children withgrowth hormone deficiency. Journalof Clinical Endocrinology and Metabolism1999 January; 84(1): 82-9.

Yohay D, Lunenfeld E, Giat Y, et al: Dochanges in growth hormone levelscorrelate with IGF-I levels in patientsundergoing IVF-ET? GynecologicalEndocrinology 1997 August; 11(4): 269-74.

Jorgensen JO, Pedersen SB, Borglum J,et al: Serum concentrations of insulin-like growth factors (IGFs), IGF bindingproteins 1 and 3 and growth hormonebinding protein in obese women andthe effects of growth hormoneadministration: a double-blind,placebo- controlled study. EuropeanJournal of Endocrinology 1995 July;133(1): 65-70.

Chapman IM, Hartman ML, Pieper KS,et al: Recovery of growth hormonerelease from suppression byexogenous insulin-like growth factorI (IGF-I): evidence for a suppressiveaction of free rather than bound IGF-I. Journal of Clinical Endocrinology andMetabolism 1998 August; 83(8): 2836-42.

Murphy LJ, Seneviratne C, Moreira P, etal: Enhanced expression of insulin-like

99-6

R E F E R E N C E S

w w w . a m t r x . c o m

FORMULA

% DV (Daily Value) Percentage of U.S. Recommended DailyAllowance (RDA) for adults and children four or more years of age.

Ingredients:Amino acids including alanine, arginine,glutamine, glycine, histidine, isoleucine,leucine, lysine, phenylalanine, proline,serine, threonine, tryptophan, tyrosine,and valine, germaben, propylene glycol,sorbitol, almond oil and/or apricot oil,carnation/jasmine fragrance, sorbitol,distilled water, in a creme’ base withEVITO™ (proprietary formula consisting ofoleic acid, linoleic acid, gamma linolenicacid, stearic acid, hexadecenoic acid,palmitic acid, eicosenoic acid, docosenoicacid, tetracosenoic acid, eicosapentaenoicacid, docosahexaenoic acid, myristic acid,lauric acid, caprylic acid, capric acid, a, b, g& d tocopherols, tocotrieols, and naturallyoccurring antioxidants and bioflavinoids).

Manufactured Exclusively forBalance Dermaceuticals®Ltd.

www.balancederm.com

Trans-D Tropin®

Disp: 30 cc (900 gtts) - Use as directed

Use ONLY Under Medical Supervision

www.balancederm.com NDC 65448-2115-1

®

Warnings:Do not use if pregnant, under the age of 18(unless GH deficiency has been established)or if you have a pituitary tumor. Keep outof reach of children. Do not use withGH Injection Therapy.

Directions:Shake well before use. Keep out ofextreme temperatures. Use as directedby your physician or apply 15 drops 3times per day, five days on, two days off.Repeat each week. Apply at 7:30 am, 4:30pm, and at bedtime. Apply 1/2 dose toinside of each forearm and rub together.Try NOT to use fingers for application.

For external use only.MANUFACTURED BYV-SAB MEDICAL LABS INC.CORNELIUS, NC 28031

FOR MEDICAL USE ONLY.®

growth factor-binding protein-I in thefasted rat: the effects of insulin andgrowth hormone administration.Endocrinology 1991 February; 128(2):689-96.

Juul A, Andersson AM, Pedersen SA, etal: Effects of growth hormonereplacement therapy on IGF-relatedparameters and on the pituitary-gonadal axis in GH-deficient males. Adouble- blind, placebo-controlledcrossover study. Hormonal Research1998; 49(6): 269-78.

Rooyackers OE, Nair KS: Hormonalregulation of human muscle proteinmetabolism. Annual Review in Nutrition1997 Annual; 17: 457-485.

Attard-Montalto SP, Camachoo-HubnerC, Cotterill AM: Changes in proteinturnover, IGF-1 and IGF bindingproteins in children with cancer. ActaPaediatrica 1998 January; 87(1): 54-60.

Chwals WJ, Bistrian BR: Role ofexogenous GH and IGF-1 inmalnutrition and acute metabolicstress: a hypothesis. Critical CareMedicine 1991 October; 19(10): 1317-1322.

Malarkey WB, Burleson M, Cacioppo JT,et al: Differential effects of estrogenand medroxyprogesterone on basaland stress-induced growth hormonerelease, IGF-1 levels, and cellularimmunity in postmenopausal women.Endocrine 1997 October; 7(2): 227-233.

Balteskard L, Unneberg K, Mjaaland M,et al: GH and IGF-1 promoteintestinal uptake and hepatic releaseof glutamine in sepsis. Annals ofSurgery 1998 July; 228(1): 131-139.

Isgaard J, Tivesten A, Friberg P, et al: Therole of the GH / IGF-1 axis for cardiacfunction and structure. HormonalMetabolism Research 1999 February-March; 31(2-3): 50-54.

Cittadini A, Longobardi S, Fazio S, et al:Growth hormone and the heart.Miner Electrolyte Metabolism 1999January-April; 25(1-2): 51-55.

Bates AS, Evans AJ, Jones P, et al:Assessment of GH status in adultswith GH deficiency using serum GH,serum IGF-1 and urinary GHexcretion. Clinical Endocrinology 1995April; 42(4): 425-430.

Wolf SE, Barrow RE, Herndon DN: GHand IGF-1 therapy in thehypercatabolic patient. BaillieresClinical Endocrinology Metabolism 1996July; 10(3): 447-463.

99-7

R E F E R E N C E S

w w w . a m t r x . c o m

Ferraccioli G, Guerra P, Rizzi V, et al:Somatomedin C (IGF-1) levelsdecrease during acute changes ofstress related hormones. Relevancefor fibromyalgia. Journal ofRheumatology 1994 July; 21(7): 1332-1334.

Farmer C, Dubreuil P, Couture Y, et al:Hormonal changes following an acutestress in control and somatostatin-immunized pigs. Domestic AnimalEndocrinology 1991 October; 8(4):527-536.

Hagberg JM, Seals DR, Yerg JE, et al:Metabolic responses to exercise inyoung and older athletes andsedentary men. Journal of AppliedPhysiology 1988 August; 65(2): 900-908.

McCusker RH: Controlling IGF activityand the modulation of IGF bindingprotein and receptor binding. Journalof Dairy Science 1998 June; 81(6):1790-1800.

Aimaretti G, Corneli G, Razzore P, et al:Usefulness of IGF-1 assay for thediagnosis of GH deficiency in adults.Journal of Endocrinology Investigation1998 September; 21(8): 506-511.

Houston-Bolze MS, Downing MT, SayedAM, et al: Serum IGF binding protein-3 responds differently to trauma inmen and women. Critical CareMedicine 1996 December; 24(12):1988-1992.

Stromer H, Cittadini A, Douglas PS, etal: Exogenously administered GHand IGF-1 alter intracellular Ca2+

handling and enhance cardiacperformance. In vitro evaluation inthe isolated isovolumic buffer-perfused rat heart. Critical Research1996 August; 79(2): 227-236.

Kozakowski J, Adamkiewicz M,Krassowski J, et al: The beneficialeffects of GH replacement therapyon elderly men. Polish Merkuriusz Lek1999 March; 6(33): 131-134.

Rollero A, Murialdo G, Fonzi S, et al:Relationship between cognitivefunction, GH and IGF-1 plasma levelsin aged subjects. Neuropsychobiology1998; 38(2): 73-79.

Girard N, Boulanger L, Denis S, et al:Differential in vivo regulation of thepituitary GHRH (GH releasinghormone) receptor by GHRH inyoung and aged rats. Endocrinology1999 June; 140(6): 2836-2842.

Carani C, Granata AR, De Rosa M, et al:The effect of chronic treatment withGH on gonadal function in men withisolated GH deficiency. European

Journal of Endocrinology 1999 March;140(3): 224-230.

Bulow B, Erfurth EM: A low individualizedGH dose in young patients withchildhood onset GH deficiencynormalized serum IGF-1 withoutsignificant deterioration in glucosetolerance. Clinical Endocrinology 1999January; 50(1): 45-55.

Janssen YJ, Helmerhorst F, Frolich M,Roelfsema F, et al: A switch from oral(2 mg/day) to trans-dermal (50 micro/day) 17 beta-estradiol therapyincreases serum IGF-I levels inrecombinant hGH substituted womenwith GH deficiency. Journal of ClinicalEndocrinology and Metabolism 2000January 85 (1): 464-466.

Inuki T, Takanashi K, Takebayashi K, FuiwaraY, Tayama K, Takemura Y, et al: Thyroidhormone modulates insulin-likegrowth factor-1(IGF-1) and IGF-binding protein-3, without mediationby growth hormone, in patients withautoimmune thyroid disease.Metabolism Research 1999 October 31(10): 576 – 579.

Yaker S, et al: Normal growth anddevelopment in the absence of hepaticIGF-1. Proc. Natl. Acad. Sci. USA 1999;96: 7324-7329.

Ohlsson C, Sjogren K, Jansson JO andIsaksson OG: The relative importanceof endocrine versus autocrine/paracrine IGF-1 in the regulation ofbody growth. Pediatric Nephrology2000;14: 541-543.

Cohen, Pinchas, et al. Insulin-like growthfactors (IGFs), IGF receptors, and IGF-binding proteins in primary cultures ofprostate epithelial cells. Journal ofClinical Endocrinology and Metabolism1991;73(2): 401-407.

Rosenfeld, RG, et al. Insulin-like growthfactor binding proteins in neoplasia(meeting abstract). Hormones andGrowth Factors in Development andNeoplasia, Fogar ty InternationalConference 1995 June 26-28, Bethesda,MD: 24.

Lippman, Marc E. The development ofbiological therapies for breast cancer.Science 1993 January 29;259: 631-632.

Papa, Vincenzo, et al. Insulin-like growthfactor-I receptors are overexpressedand predict a low risk in human breastcancer. Cancer Research 1993;53: 3736-3740.

Chan, June M., et al. Plasma insulin-likegrowth factor I and prostate cancerrisk: a prospective study. Science 1998January 23; 279: 563-566.

Stoll, BA. Breast cancer: further metabolic-

endocrine risk markers? British Journal ofCancer 1997;76(12): 1652-1654.

LeRoith, Derek, et al. The role of the insulin-like growth factor-I receptor in cancer.Annals New York Academy of Sciences 1995September 7;766: 402-408.

Mantzoros, CS, et al. Insulin-like growthfactor 1 in relation to prostate cancerand benign prostatic hyperplasia. BritishJournal of Cancer 1997; 76(9): 1115-1118.

Cascinu, S., et al. Inhibition of tumor cellkinetics and serum insulin growth factorI levels by octreotide in colorectal cancerpatients. Gastroenterology 1997September;113: 767-772.

Yu, Herbert and Rohan, Thomas. Role ofInsulin-Like Growth Factor Family inCancer Development and Progression.Journal of the National Cancer Institute 2000September 20; 92(18): 1472- 1489.

R. K. Murry, D.K. Granner. P. A. Mayes, V. W.Rodwell, Harper’s Biochemistry, 24 Ed,1996 Pg 522-532,595.

R. Gullermin et al., Science 218,585 (1982).

K. Chihara et al., J Clin Endocriol Metlab., 60,269 (1985).

99-8

w w w . a m t r x . c o m

Pharmaceutical GradeI n g r e d i e n t s **

All ingredients in the Balance Dermaceuticals® therapeutic product line are of the highest possible quality available. Allingredients are pharmaceutical grade or higher, when applicable. Certain ingredients, herbs as an example, do not havea designation of pharmaceutical grade. However, of these ingredients that are included in the Balance Dermaceuticals®

therapeutic product line, all are tested extensively and analyzed to ensure the highest possible quality, potency andpurity. This ensures that you are provided with the most efficacious therapeutics and protocols available in the medicalmarketplace today.

All Balance Dermaceuticals® therapeutics are manufactured in FDA registered and inspected laboratories and adhere toGMP (Good Manufacturing Processes) standards. All protocols, products and therapeutics not only meet but consistentlyexceed USP standards. The manufacturing facilities take great measures to ensure unparalleled integrity of everyproduct manufactured and Balance Dermaceuticals® prides itself on demanding superior quality throughout every stepof the manufacturing process. Written standard operating procedures (SOP) prepared in accordance with GMP fornutritional supplement USP XXIV production are meticulously followed in order to adhere to strict in-process qualitycontrol standards.

Every raw material ingredient is inspected and undergoes stringent quality control measures prior to production. Allraw products used are obtained from the most reliable and well-reputed sources. Processing and storage of rawmaterials as well as harvesting time and transportation methods have all been addressed. Extraction methodologiesused are unique to each separate component and are based on maintaining stability of active constituents. As a result,cold process extraction methods are predominantly utilized when possible with chemical and heat extraction methodsused only when absolutely necessary.

During initial stages of production, stringent testing and sampling is conducted before any further production cycles areallowed to continue. Accuracy is paramount and meticulous records are kept of each component and the quantity usedin every batch of product. The testing laboratories supervised by PhD’s, precisely monitor the production cycle of allproducts. The chemical analysis lab carefully ensures dissociation constants and disintegration factors as well as dissolutionand pH testing. The microbiology lab conducts microbial testing on all applicable products to exceed the USPmicrobiological limit requirements for nutritional therapeutics.

The physical analysis lab checks the weight, hardness and thickness for consistency on all tablets, guaranteeing consistentintegrity of each formulation. Potency is verified by high performance liquid chromatography or inductive coupledplasma atomic emission spectrometry, ensuring that the products will not contain less than 100% of the label claim. Allfinished products are tested for quality assurance purposes, using advanced technologies such as assay analysis andelectrophoresis testing and have independent certificate of analysis.

The manufacturing facilities are maintained at constant temperature and humidity levels to ensure optimal freshness ofall products produced. The Balance Dermaceuticals® products contain no yeast, wheat, gluten, soy protein, milk, corn,sodium, sugar, starch, artificial coloring, preservatives, or flavoring unless otherwise specifically noted.

Use ONLY Under Medical Supervision.All ingredients are pharmaceutical grade or higher.** The quality and purityof each protocol is assured. Certificate of analysis is available upon request.

Manufactured in FDA inspected laboratories, using strict GMP Standards.These statements have not been evaluated by the Food and Drug Administration.

This protocol is not intended to diagnose, treat, cure or prevent any disease.

Manufactured exclusively for Balance Dermaceuticals®

©2000-2002 Balance Dermaceuticals®. All Rights Reserved.Revised 5/31/2002