Lactulose is a disaccharide derivative of lactose used to treat constipation and portal systemic encephalopathy.

Brand Names
Constulose, Enulose, Generlac, Kristalose
Generic Name
DrugBank Accession Number

Lactulose is a synthetic disaccharide derivative of lactose that is most commonly used as a laxative agent despite also being formally indicated to serve as an adjunct therapy in treating portal-systemic encephalopathy (PSE).Label,3,4 Despite being first synthesized in 19291, investigations regarding its possible use as a laxative for the treatment of chronic constipation did not occur until the 1960s and its first clinical use for treating PSE was not until 1966.4

Nevertheless, although lactulose received formal FDA approval in 1977 and has since become a readily available generic and brand-name non-prescription medication listed on the World Health Organization's List of Essential Medicines as one of the most effective and safe medicines employed in a health system5, data regarding its optimal place in therapy is often ambiguous.4

Especially considering the use of lactulose as a laxative is typically only considered after lifestyle and dietary modifications fail and the fact that lactulose therapy cannot be ethically withheld from patients diagnosed with PSE in a placebo study, the substance may just be one of many options available for treating constipation and its efficacy in managing PSE may never be formally confirmed or refuted via clinical investigation.4

Small Molecule
Average: 342.2965
Monoisotopic: 342.116211546
Chemical Formula
  • 4-O-beta-D-Galactopyranosyl-D-fructofuranose
  • 4-O-beta-D-Galactopyranosyl-D-fructose
  • Lactulosa
  • Lactulose
  • Lactulosum



Lactulose is indicated for use as a laxative in the treatment of chronic constipation in adults and geriatric patients.Label,3,4

Additionally, lactulose is also employed as an adjunct to protein restriction and supportive therapy for the prevention and treatment of portal-systemic encephalopathy (PSE), including both the hepatic pre-coma and coma variations.Label,3,4 In particular, lactulose solution has been effective at managing PSE resulting from surgical portacaval shunts or from chronic hepatic diseases like cirrhosis.3

Moreover, there have also been studies demonstrating the capacity for lactulose to minimize the formation of gallstones and even some investigations regarding the experimental use of the agent in developing novel anticancer agents owing to its ability to bind galactin carbohydrates involved in various tumor progressions 4.

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofConstipation••••••••••••••••••••
Treatment ofHepatic encephalopathy••••••••••••••••••••
Prophylaxis ofHepatic encephalopathy••••••••••••••••••••
Contraindications & Blackbox Warnings
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Lactulose formulations are most commonly administered via the oral route or the rectal route.4 Consequently, because the substance experiences minimal absorption by the gut it typically remains localized in the gastrointestinal tract environment and ultimately demonstrates almost all of its pharmacologic effects within the gut.Label,3,4 In particular, as lactulose elicits its laxative effects in enhancing stool amounts and softening stool, such biochemical and physiologic activities can cause increased bowel sounds (borborygmi), a feeling of bloatedness, belching, frequent flatus, and diarrhea.Label,3,4

Mechanism of action

Lactulose is a synthetic disaccharide derivative of lactose that consists of one molecule of galactose and one molecule of fructose.Label,3,4 Saccharolytic bacteria present in the large intestine subsequently break the substance down into organic acids like lactic acid and small amounts of formic and acetic acids.Label,3,4 Such resultant volatile fatty acid metabolites, in combination with hydrogen and methane that is also generated consequently enhance intraluminal gas formation, peristaltic gut motility, and elicit an osmotic effect that facilitates an increase in the water content of stool as well as associated stool softening.Label,3,4 All of these actions ultimately assist in facilitating and increasing the frequency of bowel movements in patients experiencing constipation, although it may take 24 to 48 hours after using the medication for this laxative effect to become evident.Label,3,4

At the same time, the formation of such acids via the metabolism of lactulose by colonic bacteria also acidifies the contents of the colon, thereby contributing to the treatment of portal-systemic encephalopathy (PSE).Label,3,4 As one of the principal features of PSE involves the accumulation of nitrogenous waste products like ammonia in the systemic circulation, a state in which the colonic contents become more acidic than blood allows ammonia in the circulation to diffuse into the colon.Label,3,4. Furthermore, ammonia that diffuses into the acidic colon is ionized to ammonium ions that are incapable of being absorbed back into the blood.Label,3,4 These effects, combined with the laxative action of lactulose facilitates the excretion of excess ammonia.Label,3,4 And finally, it is also believed that an acidic colonic environment results in the elimination of urease-producing bacteria that contribute to the formation of ammonia while surviving colonic bacteria use up any trapped ammonia in the colon as a source of nitrogen for protein synthesis.4

UEvolved beta-galactosidase subunit alpha
Escherichia coli (strain K12)

After administration by the oral route, less than 3% of the given dose of lactulose solution is absorbed by the small intestine.3 The remaining unabsorbed lactulose reaches the large intestine where it is metabolized - but even then, negligible quantities of unchanged lactulose or its metabolites are absorbed across the colon.3,4

Volume of distribution

Negligible amounts of lactulose - metabolized or non-metabolized - are absorbed into the body.Label,3,4. Most lactulose that is administered subsequently remains predominantly around the gastrointestinal tract area.

Protein binding

Negligible amounts of lactulose - metabolized or non-metabolized - are absorbed into the body.Label,3,4. Regardless, data regarding the protein binding of lactulose is not readily available or accessible.


Lactulose is essentially only metabolized in the colon by saccharolytic bacteria that are present there.Label,3,4 In particular, the substance is broken down into lactic acid and small amounts of acetic and formic acid.Label,3,4 Specific examples of bacteria that normally inhabit the large intestine that are capable of lactulose metabolism include Lactobacilli, Bacteroides, Escherichia coli, and Clostridia.3

Hover over products below to view reaction partners

Route of elimination

The renal excretion of any lactulose that manages to be absorbed into the circulation has been determined to be 3% or less and is generally complete within 24 hours.Label Any unabsorbed lactulose is largely excreted with stool.Label,3,4


The data regarding the half-life of lactulose is not readily available or accessible.


Negligible amounts of lactulose - metabolized or non-metabolized - are absorbed into the body.Label,3,4. Regardless, data regarding the clearance of lactulose is not readily available or accessible.

Adverse Effects
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It has been documented that the oral LD50 of lactulose is 48.8 mL/kg in mice and more than 30 mL/ kg in rats.Label,3,4

It is expected that overdosage with lactulose would result in abdominal cramps and diarrhea, both of which should be treated with fluid and electrolyte replacement as required.Label,3,4

Considering the use of lactulose during pregnancy in humans has not been formally investigated, the agent should only be used during pregnancy only when clearly needed.Label,3,4 Similarly, it is unknown whether lactulose is distributed into human breastmilk.Label,3,4 Use of the medication in nursing women should subsequently be undertaken with caution.Label,3,4

Reproduction studies in rats, mice, and rabbits have not revealed any evidence of impaired fertility as a result of administering lactulose.Label,3,4

Data regarding the safety and efficacy of using lactulose in children for the treatment of chronic constipation or portal-systemic encephalopathy (PSE) is either very limited or yet to be established.Label,3,4

Information regarding the long-term mutagenic potential of lactulose solution in animals or humans and about the long-term carcinogenic potential in humans are not available.Label,3,4

Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
AcenocoumarolThe risk or severity of bleeding can be increased when Lactulose is combined with Acenocoumarol.
AcetazolamideThe risk or severity of dehydration can be increased when Acetazolamide is combined with Lactulose.
Acetyl sulfisoxazoleThe therapeutic efficacy of Lactulose can be decreased when used in combination with Acetyl sulfisoxazole.
AclidiniumThe therapeutic efficacy of Lactulose can be decreased when used in combination with Aclidinium.
AlfentanilThe therapeutic efficacy of Lactulose can be decreased when used in combination with Alfentanil.
Food Interactions
  • Drink plenty of fluids. This drug may cause fluid loss.
  • Take with or without food.


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International/Other Brands
Bifiteral (Abbott) / Cephulac / Cholac (Alra) / Chronulac / Constilac (Alra) / Laevolac (Roche)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
LactuloseSolution10 g/15mLOralANI Pharmaceuticals Inc.2009-05-212009-05-21US flag
LactuloseSolution10 g/15mLOral; RectalANI Pharmaceuticals Inc.2008-12-162008-12-16US flag
Generic Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
ConstuloseSolution10 g/15mLOralA-S Medication Solutions2011-02-28Not applicableUS flag
ConstuloseSolution10 g/15mLOralActavis Pharma, Inc.2011-02-28Not applicableUS flag
ConstuloseSolution10 g/15mLOralActavis Mid Atlantic LLC,2007-01-032012-02-29US flag
EnuloseLiquid10 g/15mLOral; RectalActavis Pharma, LLC1990-10-312012-08-31US flag
EnuloseSolution10 g/15mLOral; RectalActavis Pharma, Inc.2011-02-28Not applicableUS flag
Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
ANPROLAC SOLUTION 670mg/mlSolutionOralMALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.2020-09-08Not applicableMalaysia flag
AVELAC ORAL SOLUTION 667mg/mlSolutionOralAPEX PHARMACY MARKETING SDN. BHD.2020-09-08Not applicableMalaysia flag
Cephulac Syr 667mg/mlSyrup667 mg / mLOralHoechst Marion Roussel1995-12-311998-08-12Canada flag
Chronulac SyrSyrup667 mgOralMerrell Pharms Inc., Division Of Merrell Dow (Can)1977-12-311996-09-09Canada flag
Chronulac Syr 667mg/mlSyrup667 mg / mLOralHoechst Marion Roussel1996-12-311998-08-12Canada flag


ATC Codes
A06AD61 — Lactulose, combinationsA06AD11 — Lactulose
Drug Categories
Chemical TaxonomyProvided by Classyfire
This compound belongs to the class of organic compounds known as o-glycosyl compounds. These are glycoside in which a sugar group is bonded through one carbon to another group via a O-glycosidic bond.
Organic compounds
Super Class
Organic oxygen compounds
Organooxygen compounds
Sub Class
Carbohydrates and carbohydrate conjugates
Direct Parent
O-glycosyl compounds
Alternative Parents
Disaccharides / C-glycosyl compounds / Oxanes / Tetrahydrofurans / Secondary alcohols / Hemiacetals / Polyols / Oxacyclic compounds / Acetals / Primary alcohols
show 1 more
Acetal / Alcohol / Aliphatic heteromonocyclic compound / C-glycosyl compound / Disaccharide / Hemiacetal / Hydrocarbon derivative / O-glycosyl compound / Organoheterocyclic compound / Oxacycle
show 5 more
Molecular Framework
Aliphatic heteromonocyclic compounds
External Descriptors
glycosylfructose (CHEBI:6359)
Affected organisms
  • Humans and other mammals

Chemical Identifiers

CAS number
InChI Key


Synthesis Reference

Renato Carobbi, Franco Innocenti, "Process for preparing high-purity lactulose syrup and the syrup obtained." U.S. Patent US4978397, issued April, 1961.

General References
  1. Schumann C: Medical, nutritional and technological properties of lactulose. An update. Eur J Nutr. 2002 Nov;41 Suppl 1:I17-25. doi: 10.1007/s00394-002-1103-6. [Article]
  2. Canadian Pharmacists Association (2019). Compendium of Pharmaceuticals and Specialties. Canadian Pharmacists Association.
  3. Lactulose Canadian Product Monograph [Link]
  4. NCBI StatPearls [Internet]: Lactulose [Link]
  5. WHO Model List of Essential Medicines 19th List (April 2015 - Amended November 2015) [Link]
  6. DailyMed: lactulose solution [Link]
Human Metabolome Database
KEGG Compound
PubChem Compound
PubChem Substance
RxList Drug Page Drug Page
PDRhealth Drug Page
PDB Entries
3w9t / 6b8k / 6b94 / 6nwm
FDA label
Download (151 KB)
Download (73.6 KB)

Clinical Trials

Clinical Trials
4CompletedNot AvailableOsteopenia (Disorder)1
4CompletedBasic ScienceMotility Disorder of Intestine / Ondansetron / Small Bowel Water1
4CompletedBasic ScienceType 2 Diabetes Mellitus1
4CompletedPreventionHepatic Encephalopathy (HE)1
4CompletedTreatmentCirrhosis of the Liver / Hepatic Encephalopathy (HE)1


  • Inalco spa
  • Sanofi aventis us llc
  • Alra laboratories inc
  • Actavis mid atlantic llc
  • Solvay pharmaceuticals
  • Teva pharmaceuticals usa
  • Ani pharmaceuticals inc
  • Hi tech pharmacal co inc
  • Morton grove pharmaceuticals inc
  • Novex pharma
  • Paco pharmaceutical services inc
  • Pharmaceutical assoc inc div beach products
  • Roxane laboratories inc
  • Vintage pharmaceuticals inc
  • Vistapharm inc
  • Nostrum laboratories inc
  • Actavis Group
  • Advanced Pharmaceutical Services Inc.
  • Anip Acquisition Co.
  • Apotex Inc.
  • A-S Medication Solutions LLC
  • Bay Pharma Inc.
  • Cardinal Health
  • Cumberland Pharmaceuticals
  • Diversified Healthcare Services Inc.
  • DPT Laboratories Ltd.
  • Goldline Laboratories Inc.
  • H.J. Harkins Co. Inc.
  • Hi Tech Pharmacal Co. Inc.
  • Infra SRL
  • Innoviant Pharmacy Inc.
  • Ivers Lee Division Of Jones Packaging Inc.
  • Major Pharmaceuticals
  • Merrell Pharmaceuticals Inc.
  • Moeller Pharma GmbH and Co. KG
  • Novex Pharma
  • Palmetto Pharmaceuticals Inc.
  • Pharmaceutical Association
  • Pharmaceutical Packaging Center
  • Physicians Total Care Inc.
  • Precision Dose Inc.
  • Qualitest
  • Ratiopharm Inc.
  • Resolution Chemicals Ltd.
  • Roxane Labs
  • Solvay Pharmaceuticals
  • United Research Laboratories Inc.
  • Vintage Pharmaceuticals Inc.
  • Vistapharm Inc.
  • Watson Pharmaceuticals
  • Wockhardt Ltd.
  • Xactdose Inc.
Dosage Forms
SyrupOral3.335 g/5mL
PowderParenteral10 g/10g
SolutionOral667 MG/ML
SyrupOral667 mg / mL
SyrupOral667 mg
SyrupOral; Rectal10 g / 15 mL
SolutionOral66.7 g
PowderOral95 g / 100 g
SyrupOral66.700 g
PowderOral950 mg / g
SyrupOral67 g/100ml
LiquidOral; Rectal10 g/15mL
Granule, for solutionOral3 g
Granule, for solutionOral9 g
Syrup65 %
Granule, for solutionOral12 G
Granule, for solutionOral6 G
Powder, for solutionOral12 g
Powder, for solutionOral3 g
Powder, for solutionOral6 g
Powder, for solutionOral9 g
SolutionOral200 ML
SolutionOral400 ML
SyrupOral65 %
SolutionOral670 MG/ML
LiquidOral667 mg / mL
SolutionOral667 mg / mL
Powder, for solutionOral10 g/10g
Powder, for solutionOral20 g/20g
SolutionOral650 mg/ml
SyrupOral670 mg/ml
SyrupOral66.66 g
SyrupOral10 g / 15 mL
SolutionOral10 g/10g
SolutionOral10 g/15mL
SolutionOral20 g/30mL
SolutionOral; Rectal10 g/15mL
SyrupOral66.7 G/100ML
SolutionOral10 g / 15 mL
SyrupOral650 mg/ml
SyrupOral66.7 g
SyrupOral66 % w/v
Powder, for solutionOral
Syrup670 mg/ml
Powder, for solutionOral10 g
Powder, for solutionOral5 g
SyrupOral180 ML
SyrupOral370 ML
SyrupOral66.6 %
SyrupOral66.7 %
SyrupOral66.7 MG
SyrupOral90 ML
Syrup67.0 G/100ML
Granule, for solutionRectal200 G
Syrup66.7 %
Syrup66.7 G/100ML
Syrup667 MG/ML
Granule, for solutionOral
Granule, for solutionOral10 G
SyrupOral10 g/15ml
SyrupOral120 ML
SyrupOral200 ML
SyrupOral250 ML
SyrupOral400 ML
SyrupOral66.660 g
SolutionOral667 mg
SyrupOral667 mg/ml
Syrup300 ML
SyrupOral66.666 g
Drug delivery systemOral5.000 g
GelOral35.0000 g
SolutionOral3.35 G/5ml
SyrupOral3.3 g / 5 mL
Unit descriptionCostUnit
Kristalose 30 20 gm Packets Box83.93USD box
Kristalose 30 10 gm Packets Box57.57USD box
Enulose 10 gm/15ml Solution 473ml Bottle37.83USD bottle
Kristalose 20 gm packet2.04USD each
Kristalose 10 gm packet1.67USD each
Constulose 10 gm/15 ml soln0.09USD ml
Enulose 10 gm/15 ml solution0.08USD ml
Lactulose Encephalopathy 10 gm/15ml Solution0.08USD ml
Lactulose 10 gm/15ml Solution0.07USD ml
Generlac 10 gm/15 ml solution0.05USD ml
Apo-Lactulose 667 mg/ml Syrup0.02USD ml
Jamp-Lactulose 667 mg/ml Syrup0.02USD ml
Pms-Lactulose 667 mg/ml Syrup0.02USD ml
Ratio-Lactulose 667 mg/ml Syrup0.02USD ml
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Not Available


Experimental Properties
melting point (°C)169 °C
water solubilitySoluble in cold water, hot water. Solubility in water: 76.4% @ 30 deg. CMSDS
Predicted Properties
Water Solubility792.0 mg/mLALOGPS
pKa (Strongest Acidic)10.28Chemaxon
pKa (Strongest Basic)-3Chemaxon
Physiological Charge0Chemaxon
Hydrogen Acceptor Count11Chemaxon
Hydrogen Donor Count8Chemaxon
Polar Surface Area189.53 Å2Chemaxon
Rotatable Bond Count5Chemaxon
Refractivity68.77 m3·mol-1Chemaxon
Polarizability31.48 Å3Chemaxon
Number of Rings2Chemaxon
Rule of FiveNoChemaxon
Ghose FilterNoChemaxon
Veber's RuleNoChemaxon
MDDR-like RuleNoChemaxon
Predicted ADMET Features
Human Intestinal Absorption-0.8407
Blood Brain Barrier+0.6609
Caco-2 permeable-0.8957
P-glycoprotein substrateNon-substrate0.5805
P-glycoprotein inhibitor INon-inhibitor0.8575
P-glycoprotein inhibitor IINon-inhibitor0.9425
Renal organic cation transporterNon-inhibitor0.849
CYP450 2C9 substrateNon-substrate0.8745
CYP450 2D6 substrateNon-substrate0.854
CYP450 3A4 substrateNon-substrate0.6605
CYP450 1A2 substrateNon-inhibitor0.9472
CYP450 2C9 inhibitorNon-inhibitor0.9556
CYP450 2D6 inhibitorNon-inhibitor0.9386
CYP450 2C19 inhibitorNon-inhibitor0.9134
CYP450 3A4 inhibitorNon-inhibitor0.9774
CYP450 inhibitory promiscuityLow CYP Inhibitory Promiscuity0.9619
Ames testNon AMES toxic0.9421
BiodegradationNot ready biodegradable0.6719
Rat acute toxicity1.2563 LD50, mol/kg Not applicable
hERG inhibition (predictor I)Weak inhibitor0.9692
hERG inhibition (predictor II)Non-inhibitor0.8684
ADMET data is predicted using admetSAR, a free tool for evaluating chemical ADMET properties. (23092397)


Mass Spec (NIST)
Not Available
SpectrumSpectrum TypeSplash Key
Predicted GC-MS Spectrum - GC-MSPredicted GC-MSsplash10-0il0-3698000000-36edcab1ee8bdc27053f
GC-MS Spectrum - GC-EI-TOFGC-MSsplash10-0uxr-0951000000-d976341b4e779d2fcb68
GC-MS Spectrum - GC-EI-TOFGC-MSsplash10-0udj-0941000000-e16e35441da7b81d64a1
Predicted MS/MS Spectrum - 10V, Positive (Annotated)Predicted LC-MS/MSsplash10-01td-0709000000-e957a63212e872ef0f5a
Predicted MS/MS Spectrum - 10V, Negative (Annotated)Predicted LC-MS/MSsplash10-007o-0396000000-3af247764a06ecf3dcc5
Predicted MS/MS Spectrum - 20V, Positive (Annotated)Predicted LC-MS/MSsplash10-01pk-0963000000-2dd1cde3a0ef1aa93d4a
Predicted MS/MS Spectrum - 20V, Negative (Annotated)Predicted LC-MS/MSsplash10-008c-1193000000-484de6d0878217573749
Predicted MS/MS Spectrum - 40V, Positive (Annotated)Predicted LC-MS/MSsplash10-014i-4290000000-44df07ecd6da47329ba1
Predicted MS/MS Spectrum - 40V, Negative (Annotated)Predicted LC-MS/MSsplash10-0ar0-9850000000-94d616c03b6549d93052
Predicted 1H NMR Spectrum1D NMRNot Applicable
Predicted 13C NMR Spectrum1D NMRNot Applicable
Chromatographic Properties
Collision Cross Sections (CCS)
AdductCCS Value (Å2)Source typeSource
DarkChem Lite v0.1.0
DarkChem Lite v0.1.0
DarkChem Lite v0.1.0
DeepCCS 1.0 (2019)
DarkChem Lite v0.1.0
DarkChem Lite v0.1.0
DarkChem Lite v0.1.0
DeepCCS 1.0 (2019)
DarkChem Lite v0.1.0
DarkChem Standard v0.1.0
DarkChem Lite v0.1.0
DeepCCS 1.0 (2019)


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Escherichia coli (strain K12)
Pharmacological action
General Function
Carbohydrate binding
Specific Function
The wild-type enzyme is an ineffective lactase. Two classes of point mutations dramatically improve activity of the enzyme.
Gene Name
Uniprot ID
Uniprot Name
Evolved beta-galactosidase subunit alpha
Molecular Weight
117878.225 Da
  1. Overington JP, Al-Lazikani B, Hopkins AL: How many drug targets are there? Nat Rev Drug Discov. 2006 Dec;5(12):993-6. [Article]
  2. Imming P, Sinning C, Meyer A: Drugs, their targets and the nature and number of drug targets. Nat Rev Drug Discov. 2006 Oct;5(10):821-34. [Article]
  3. Bjarnason I, Batt R, Catt S, Macpherson A, Maxton D, Menzies IS: Evaluation of differential disaccharide excretion in urine for non-invasive investigation of altered intestinal disaccharidase activity caused by alpha-glucosidase inhibition, primary hypolactasia, and coeliac disease. Gut. 1996 Sep;39(3):374-81. [Article]
  4. Cook GC: Breath hydrogen concentrations after oral lactose and lactulose in tropical malabsorption and adult hypolactasia. Trans R Soc Trop Med Hyg. 1978;72(3):277-81. [Article]
  5. Noone C, Menzies IS, Banatvala JE, Scopes JW: Intestinal permeability and lactose hydrolysis in human rotaviral gastroenteritis assessed simultaneously by non-invasive differential sugar permeation. Eur J Clin Invest. 1986 Jun;16(3):217-25. [Article]
  6. Hall BG, Malik HS: Determining the evolutionary potential of a gene. Mol Biol Evol. 1998 Aug;15(8):1055-61. [Article]

Drug created at June 13, 2005 13:24 / Updated at April 22, 2024 14:28