IL299918A - A screening method for diagnosing growth hormone deficiency in pediatric patients by using macimorelin - Google Patents
A screening method for diagnosing growth hormone deficiency in pediatric patients by using macimorelinInfo
- Publication number
- IL299918A IL299918A IL299918A IL29991823A IL299918A IL 299918 A IL299918 A IL 299918A IL 299918 A IL299918 A IL 299918A IL 29991823 A IL29991823 A IL 29991823A IL 299918 A IL299918 A IL 299918A
- Authority
- IL
- Israel
- Prior art keywords
- macimorelin
- minutes
- subject
- growth hormone
- blood samples
- Prior art date
Links
- UJVDJAPJQWZRFR-DHIUTWEWSA-N 2-amino-n-[(2r)-1-[[(1r)-1-formamido-2-(1h-indol-3-yl)ethyl]amino]-3-(1h-indol-3-yl)-1-oxopropan-2-yl]-2-methylpropanamide Chemical compound C1=CC=C2C(C[C@@H](NC(=O)[C@@H](CC=3C4=CC=CC=C4NC=3)NC(=O)C(C)(N)C)NC=O)=CNC2=C1 UJVDJAPJQWZRFR-DHIUTWEWSA-N 0.000 title claims 60
- 229960000298 macimorelin Drugs 0.000 title claims 60
- 238000000034 method Methods 0.000 title claims 24
- 206010056438 Growth hormone deficiency Diseases 0.000 title claims 14
- 238000012216 screening Methods 0.000 title claims 3
- 210000004369 blood Anatomy 0.000 claims 37
- 239000008280 blood Substances 0.000 claims 37
- 102000018997 Growth Hormone Human genes 0.000 claims 25
- 108010051696 Growth Hormone Proteins 0.000 claims 25
- 239000000122 growth hormone Substances 0.000 claims 25
- 239000000126 substance Substances 0.000 claims 18
- 239000000523 sample Substances 0.000 claims 11
- 230000037396 body weight Effects 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 6
- 230000001939 inductive effect Effects 0.000 claims 5
- 230000028327 secretion Effects 0.000 claims 5
- 230000006698 induction Effects 0.000 claims 3
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 claims 2
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 2
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 2
- 229960000913 crospovidone Drugs 0.000 claims 2
- 239000012458 free base Substances 0.000 claims 2
- 229960001021 lactose monohydrate Drugs 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 2
- 229940081974 saccharin Drugs 0.000 claims 2
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims 2
- 235000019204 saccharin Nutrition 0.000 claims 2
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 claims 2
- 229940085605 saccharin sodium Drugs 0.000 claims 2
- 210000002966 serum Anatomy 0.000 claims 2
- 230000000638 stimulation Effects 0.000 claims 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
- G01N33/5091—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing the pathological state of an organism
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/61—Growth hormones [GH] (Somatotropin)
Claims (39)
1.Claims 1. A screening method for diagnosing growth hormone deficiency in pediatric patients by using macimorelin comprising: (a) providing one to five blood samples, taken from a subject within a range from about 15 to about 100 minutes following an administration of an amount of macimorelin effective for inducing growth hormone secretion; (b) measuring the growth hormone level of each blood sample provided in step (a); (c) comparing the measured growth hormone level obtained in step (b) with a single threshold value, wherein the single threshold value is 10.0 ng/mL or higher; (d) determining the subject, whose highest growth hormone level in the blood samples obtained in step (b) is lower than the single threshold value, as having growth hormone deficiency, and determining the subject, whose highest growth hormone level in the blood samples obtained in step (b) is no lower than the single threshold value, as having no growth hormone deficiency.
2. The method according to claim 1, wherein the single threshold value is within a range from about 10.0 to about 25.0 ng/mL, preferably from about 10.2 to about 20.0 ng/mL, further preferably from about 12.0 to about 19.0 ng/mL, further preferably from about 14.0 to about 18.0 ng/mL, more preferably from about 16.0 to about 18.0 ng/mL and most preferably from about 17.0 to about 18.0 ng/mL.
3. The method according to claim 1 or 2, wherein in step (a) one to four blood samples are provided, preferably wherein in step (a) one to three blood sam-ples are provided, more preferably wherein in step (a) two or three blood samples are provided. - 52 -
4. The method according to any of claims 1 to 3, wherein in step (a) the blood samples are taken from a subject within a range from about 20 to about 1minutes, preferably within a range from about 25 to about 100 minutes, more preferably within a range from about 25 to about 95 minutes and most pref-erably within a range from about 30 to about 90 minutes, following an admin- istration of an amount of macimorelin effective for inducing growth hormone secretion.
5. The method according to any of claim 1 to 4, wherein the blood samples are taken from the subject at about 10 to about 60 minute intervals, preferably about 15 to about 30 minute intervals, if more than one blood sample is pro- vided.
6. The method according to any of claims 1 to 5, wherein in step (a) the blood samples are serum samples or plasma samples.
7. The method according to any of claims 1 to 6, wherein in step (a) about 0.mg to about 1.2 mg per kg subject body weight of macimorelin is adminis- tered, preferably wherein in step (a) about 1.0 mg per kg subject body weight of macimorelin is administered.
8. The method according to any of claims 1 to 7, wherein in step (a) the admin-istration of macimorelin is oral administration.
9. The method according to any of claims 1 to 8, wherein in step (a) one blood sample is provided, which is taken from the subject at about 60±30 minutes after administration of macimorelin.
10. The method according to any of claims 1 to 8, wherein in step (a) two blood samples are provided, which are taken from the subject at about 30±minutes and at about 45±10 minutes after administration of macimorelin.
11. The method according to any of claims 1 to 8, wherein in step (a) two blood samples are provided, which are taken from the subject at about 30±minutes and at about 60±10 minutes after administration of macimorelin. - 53 -
12. The method according to any of claims 1 to 8, wherein in step (a) three blood samples are provided, which are taken from the subject at about 30±minutes, at about 45±10 minutes and at about 60±10 minutes after admin-istration of macimorelin or wherein in step (a) three blood samples are pro-vided, which are taken from the subject at about 30±10 minutes, at about 45±10 minutes and at about 90±10 minutes after administration of mac-imorelin or wherein in step (a) three blood samples are provided, which are taken from the subject at about 30±10 minutes, at about 60±10 minutes and at about 90±10 minutes after administration of macimorelin.
13. The method according to any of claims 1 to 12, wherein in step (a) the macimorelin is administered in a composition comprising macimorelin and optionally further pharmaceutically acceptable excipients, preferably wherein in step (a) the macimorelin is administered in a composition comprising mac-imorelin and optionally saccharin.
14. The method according to any of claims 1 to 13, wherein in step (a) the macimorelin is administered in a composition comprising about 3.5% (w/w) macimorelin calculated as free base, about 93.1% (w/w) spray-dried lactose monohydrate, about 2.0% (w/w) crospovidone Type A, about 0.1% (w/w) col-loidal silicon dioxide, about 1.0% (w/w) sodium stearyl fumarate, and about 0.3% (w/w) saccharin sodium dehydrate.
15. The method according to any of claims 1 to 14, wherein the subject is a human child from the age of 2 to less than 18 years.
16. The method according to any of claims 1 to 15, wherein the method is a stand-alone test and does not need to be repeated and no alternative growth hormone stimulation test is required to reliably diagnose growth hormone de- ficiency in pediatric patients.
17. The method according to any of claims 1 to 15, wherein determining the subject as having or not having growth hormone deficiency according to step (d) is exclusively based on the growth hormone level induction by a single macimorelin administration. 30 - 54 -
18. The substance macimorelin for use in diagnosing growth hormone deficiency in pediatric patients wherein (a) one to five blood samples are provided, taken from a subject within a range from about 15 to about 100 minutes following an administration of an amount of macimorelin effective for inducing growth hormone secre- tion; (b) the growth hormone level of each blood sample provided in step (a) is measured; (c) the measured growth hormone level obtained in step (b) is compared with a single threshold value, wherein the single threshold value is 10.0 ng/mL or higher; (d) the subject, whose highest growth hormone level in the blood samples obtained in step (b) is lower than the single threshold value, is determined as having growth hormone deficiency, and the subject, whose highest growth hormone level in the blood samples obtained in step (b) is no lower than the single threshold value, is determined as having no growth hor-mone deficiency.
19. The substance macimorelin for use according to claim 18, wherein the single threshold value is within a range from about 10.0 to about 25.0 ng/mL, pref-erably from about 10.2 to about 20.0 ng/mL, further preferably from about 12.0 to about 19.0 ng/mL, further preferably from about 14.0 to about 18.0 ng/mL, more preferably from about 16.0 to about 18.0 ng/mL and most pref-erably from about 17.0 to about 18.0 ng/mL.
20. The substance macimorelin for use according to claim 18 or 19, wherein in step (a) one to four blood samples are provided, preferably wherein in step (a) one to three blood samples are provided, more preferably wherein in step (a) two or three blood samples are provided. - 55 -
21. The substance macimorelin for use according to any of claims 18 to 20, wherein in step (a) the blood samples are taken from a subject within a range from about 20 to about 100 minutes, preferably within a range from about to about 100 minutes, more preferably within a range from about 25 to about minutes and most preferably within a range from about 30 to about 90 minutes, following an administration of an amount of macimorelin effective for inducing growth hormone secretion.
22. The substance macimorelin for use according to any of claims 18 to 21, wherein the blood samples are taken from the subject at about 10 to about minute intervals, preferably about 15 to about 30 minute intervals, if more than one blood sample is provided.
23. The substance macimorelin for use according to any of claim 18 to 22, wherein in step (a) the blood samples are serum samples or plasma sam-ples.
24. The substance macimorelin for use according to any of claims 18 to 23, wherein in step (a) about 0.8 mg to about 1.2 mg per kg subject body weight of macimorelin is administered, preferably wherein in step (a) about 1.0 mg per kg subject body weight of macimorelin is administered.
25. The substance macimorelin for use according to any of claims 18 to 24, wherein in step (a) the administration of macimorelin is oral administration.
26. The substance macimorelin for use according to any of claims 18 to 25, wherein in step (a) one blood sample is provided, which is taken from the subject at about 60±30 minutes after administration of macimorelin.
27. The substance macimorelin for use according to any of claims 18 to 25, wherein in step (a) two blood samples are provided, which are taken from the subject at about 30±10 minutes and at about 45±10 minutes after administra-tion of macimorelin.
28. The substance macimorelin for use according to any of claims 18 to 25, wherein in step (a) two blood samples are provided, which are taken from the - 56 - subject at about 30±10 minutes and at about 60±10 minutes after administra-tion of macimorelin.
29. The substance macimorelin for use according to any of claims 18 to 25, wherein in step (a) three blood samples are provided, which are taken from the subject at about 30±10 minutes, at about 45±10 minutes and at about 60±10 minutes after administration of macimorelin or wherein in step (a) three blood samples are provided, which are taken from the subject at about 30±10 minutes, at about 45±10 minutes and at about 90±10 minutes after administration of macimorelin or wherein in step (a) three blood samples are provided, which are taken from the subject at about 30±10 minutes, at about 60±10 minutes and at about 90±10 minutes after administration of mac-imorelin.
30. The substance macimorelin for use according to any of claims 18 to 29, wherein in step (a) the macimorelin is administered in a composition compris-ing macimorelin and optionally further pharmaceutically acceptable excipi- ents, preferably wherein in step (a) the macimorelin is administered in a composition comprising macimorelin and optionally saccharin.
31. The substance macimorelin for use according to any one of claims 18 to 29, wherein in step (a) the macimorelin is administered in a composition compris-ing about 3.5% (w/w) macimorelin calculated as free base, about 93.1% (w/w) spray-dried lactose monohydrate, about 2.0% (w/w) crospovidone Type A, about 0.1% (w/w) colloidal silicon dioxide, about 1.0% (w/w) sodium stear-yl fumarate, and about 0.3% (w/w) saccharin sodium dehydrate.
32. The substance macimorelin for use according to any of claims 18 to 31, wherein the subject is a human child from the age of 2 to less than 18 years.
33. The substance macimorelin for use according to any of claims 18 to 32, wherein the substance is used in a stand-alone test and does not need to be repeated and no alternative growth hormone stimulation test is required to re-liably diagnose growth hormone deficiency in pediatric patients. - 57 -
34. The substance macimorelin for use according to any of claims 18 to 33, wherein determining the subject as having or not having growth hormone de-ficiency according to step (d) is exclusively based on the growth hormone level induction by a single macimorelin administration.
35. A screening method for diagnosing growth hormone deficiency in pediatric patients by using macimorelin comprising: (a) providing at least one blood sample, taken from a subject within a range from about 15 to about 100 minutes following an administration of an amount of macimorelin effective for inducing growth hormone secretion; (b) measuring the growth hormone level of each blood sample; (c) comparing each of the measured growth hormone level with a single threshold value, wherein the single threshold value is within a range from about 10.0 to about 25.0 ng/mL; (d) diagnosing whether the subject suffers from growth hormone deficiency or not based on the comparison of growth hormone level measured in step (b) with said single threshold value in said at least one blood sample; wherein determining the subject as having or not having growth hormone deficiency is exclusively based on the growth hormone level induction by a single macimorelin administration.
36. The method according to claim 35, wherein in step (d) the subject, whose highest growth hormone level measured in step (b) is lower than the single threshold value, is determined as having growth hormone deficiency, and the subject, whose highest growth hormone level measured in step (b) is no low-er than the single threshold value, is determined as having no growth hor-mone deficiency
37. The method according to claim 35 or 36, wherein the single threshold value is within a range from about 10.2 to about 20.0 ng/mL, further preferably from about 12.0 to about 19.0 ng/mL, further preferably from about 14.0 to about - 58 - 18.0 ng/mL, more preferably from about 16.0 to about 18.0 ng/mL and most preferably from about 17.0 to about 18.0 ng/mL.
38. The method according to claims 35 to 37, wherein about 0.8 mg to about 1.mg per kg subject body weight of macimorelin is administered, preferably about 1.0 mg per kg subject body weight of macimorelin is administered.
39. The method according to any of claims 35 to 38, wherein the subject is a human child from the age of 2 to less than 18 years.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/EP2020/070691 WO2022017599A1 (en) | 2020-07-22 | 2020-07-22 | A screening method for diagnosing growth hormone deficiency in pediatric patients by using macimorelin |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| IL299918A true IL299918A (en) | 2023-03-01 |
Family
ID=71784051
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IL299918A IL299918A (en) | 2020-07-22 | 2020-07-22 | A screening method for diagnosing growth hormone deficiency in pediatric patients by using macimorelin |
Country Status (11)
| Country | Link |
|---|---|
| EP (1) | EP4185866A1 (en) |
| JP (1) | JP2023535000A (en) |
| KR (1) | KR102635025B1 (en) |
| CN (1) | CN114258492A (en) |
| AR (1) | AR124626A1 (en) |
| AU (1) | AU2020460118A1 (en) |
| CA (1) | CA3185680A1 (en) |
| IL (1) | IL299918A (en) |
| MX (1) | MX2023000935A (en) |
| TW (1) | TW202219511A (en) |
| WO (1) | WO2022017599A1 (en) |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SK287169B6 (en) | 2000-06-13 | 2010-02-08 | Zentaris Ag | Compounds increased growth hormone secretion, pharmaceutical compositions comprising thereof and their use |
| GB0603295D0 (en) | 2006-02-18 | 2006-03-29 | Ardana Bioscience Ltd | Methods and kits |
| CN105209055A (en) * | 2013-03-11 | 2015-12-30 | 阿穆尼克斯运营公司 | Treatment of pediatric growth hormone deficiency with human growth hormone analogues |
| CN106310229A (en) * | 2015-06-30 | 2017-01-11 | 深圳翰宇药业股份有限公司 | Macimorelin film coated tablet and preparation method thereof |
| US10288629B1 (en) | 2017-12-19 | 2019-05-14 | Aeterna Zentaris, Inc. | Method of assessing growth hormone deficiency in humans by a macimorelin containing composition |
-
2020
- 2020-07-22 JP JP2023504173A patent/JP2023535000A/en active Pending
- 2020-07-22 CN CN202080006891.5A patent/CN114258492A/en active Pending
- 2020-07-22 AU AU2020460118A patent/AU2020460118A1/en active Pending
- 2020-07-22 IL IL299918A patent/IL299918A/en unknown
- 2020-07-22 MX MX2023000935A patent/MX2023000935A/en unknown
- 2020-07-22 CA CA3185680A patent/CA3185680A1/en active Pending
- 2020-07-22 EP EP20745175.8A patent/EP4185866A1/en active Pending
- 2020-07-22 KR KR1020217043189A patent/KR102635025B1/en active IP Right Grant
- 2020-07-22 WO PCT/EP2020/070691 patent/WO2022017599A1/en unknown
-
2021
- 2021-06-23 TW TW110122905A patent/TW202219511A/en unknown
- 2021-07-20 AR ARP210102035A patent/AR124626A1/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CN114258492A (en) | 2022-03-29 |
| AU2020460118A1 (en) | 2023-02-02 |
| WO2022017599A1 (en) | 2022-01-27 |
| KR102635025B1 (en) | 2024-02-07 |
| KR20220015466A (en) | 2022-02-08 |
| TW202219511A (en) | 2022-05-16 |
| JP2023535000A (en) | 2023-08-15 |
| EP4185866A1 (en) | 2023-05-31 |
| CA3185680A1 (en) | 2022-01-27 |
| MX2023000935A (en) | 2023-02-22 |
| AR124626A1 (en) | 2023-04-19 |
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