PDE / HBEL Reports - keytoxicology

PDE / HBEL REPORTS

PDE / HBEL Reports

A PDE / HBEL reports supplied by KeyToxicology will summarise the decisions with justification and final numerical value based on a comprehensive literature search. Our experts will select the most informative current published toxicology data to calculate the PDE by oral / route of ingestion and will clearly identify any hazards known or unknown. The data and conclusions are clearly presented and data sources are referenced. As more data becomes available, the report can also be updated.

The Permitted Daily Exposure (PDE) represents a substance-specific dose that is unlikely to cause an adverse effect if an individual is exposed at or below this dose every day for a lifetime.

We have well established procedure for setting out PDEs. The toxicology experts utilizes the No Observed Adverse Effect Level (NOAEL) or Lowest Observed Adverse Effect Level (LOAEL) according to the guidelines published by the International Council for Harmonisation (Guideline Q3C: Impurities: Guideline for Residual Solvents) and the European Medicines Agency (Guideline on setting health-based exposure limits for use in the manufacture of different medicinal products in shared facilities, 2014). All available pharmacological, Pharmacodynamics and toxicological data are considered, particularly with respect to acute or chronic toxicity, carcinogenicity, mutagenicity, toxicity to reproduction and sensitization potential.

We have supplied over 1,200 PDE reports for pharmaceutical industry based in UK, EU, USA and many other countries.
The list of available PDE/ HBEL reports are as below,
Active substanceDosage form
AcetazolamideNon-sterile
Acetic acidNon-sterile
Acetyl cysteine Non-sterile
Acetylsalicylic AcidNon-sterile
AciclovirNon-sterile
Aciclovir Non-sterile
AcitretinNon-sterile
AdenosineInjection
AlbendazoleNon-sterile
Alendronic AcidNon-sterile
Alfa-tocopherolNon-sterile
Alimemazine tartrateNon-sterile
AllopurinolNon-sterile
Aluminium AcetateNon-sterile
Amantadine hydrochlorideNon-sterile
Amiloride Hydrochloride Non-sterile
Amiodarone HydrochlorideNon-sterile
AmisulprideNon-sterile
Amitriptyline hydrochlorideNon-sterile
Amlodipine besilateNon-sterile
Amoxicillin Try hydrateNon-sterile
Amoxycillin SodiumNon-sterile
Ampicillin Try HydrateNon-sterile
Anhydrous CaffeineNon-sterile
Apomorphine HydrochlorideInjection
Arginine HydrochlorideNon-sterile
AripirazoleNon-sterile
Ascorbic acidNon-sterile
AtenololNon-sterile
Atorvastatin Calcium trihydrateNon-sterile
Atropine Sulfate Non-sterile
Atropine SulphateNon-sterile
AzathioprineNon-sterile
AzithromycinNon-sterile
BaclofenNon-sterile
Beclometasone dipropionateNon-sterile
BendroflumethiazideNon-sterile
Benzoic acidNon-sterile
Benzyl benzoateNon-sterile
Betahistine DihydrochlorideNon-sterile
BetaineNon-sterile
Betamethasone dipropionateNon-sterile
Betamethasone valerateNon-sterile
BiotinNon-sterile
BisacodylNon-sterile
Bisoprolol fumarateNon-sterile
BumetanideNon-sterile
BupivacaineInjection
CaffeineNon-sterile
CaffeineInjection
CAFFEINE Non-sterile
CalamineNon-sterile
Calcium CarbonateNon-sterile
CaptoprilNon-sterile
CarbamazepineNon-sterile
CarbidopaNon-sterile
CarvedilolNon-sterile
Cefotaxime SodiumNon-sterile
CEFTAZIDIMENon-sterile
CEFTRIAXONE SODIUMNon-sterile
Celiprolol HydrochlorideNon-sterile
Cetirizine Dihydrochloride Non-sterile
Chloral hydrateNon-sterile
ChlorothiazideNon-sterile
Chlorphenamine MaleateInjection
Chlortalidone Non-sterile
Chlortalidone & AtenololNon-sterile
CiprofloxacinNon-sterile
Ciprofloxacin HydrochlorideNon-sterile
Citalopram hydrochlorideNon-sterile
Clarithromycin Non-sterile
Clindamycin HydrochlorideNon-sterile
ClioquinolNon-sterile
ClobazamNon-sterile
Clobetasol PropionateNon-sterile
Clobetasone buytrateNon-sterile
Clomifene CitrateNon-sterile
Clomipramine HydrochlorideNon-sterile
ClonazepamNon-sterile
Clonidine hydrochlorideNon-sterile
Clopidrogrel hydrogen sulfateNon-sterile
Clotrimazole Non-sterile
Coal tarNon-sterile
Cocaine HydrochlorideNon-sterile
Codeine PhosphateNon-sterile
Codeine Phosphate HemihydrateNon-sterile
Co-enzyme Q10Non-sterile
Colchicine Non-sterile
ColecalciferolNon-sterile
Colestyramine Non-sterile
Cyclizine HydrochlorideNon-sterile
Cyclizine Hydrochloride Non-sterile
CyclophosphamideNon-sterile
Cyproterone Acetate Non-sterile
Dantrolene sodiumNon-sterile
Desferrioxamine  Non-sterile
Desmopressin AcetateNon-sterile
DexamethasoneNon-sterile
Dexamethasone sodium phosphateNon-sterile
DexmedetomidineInjection
DHEA (Dehydroepiandrosterone) Non-sterile
Diamorphine HydrochlorideInjection
DiazepamNon-sterile
Diazoxide Non-sterile
Diclofenac sodium Non-sterile
Dicycloverine hydrochlorideNon-sterile
Diflucortolone valerateNon-sterile
DigoxinNon-sterile
Dihydrocodeine tartrateNon-sterile
Diltiazem HydrochlorideNon-sterile
Diphenhydramine HydrochlorideNon-sterile
DipyridamoleNon-sterile
DisopyramideNon-sterile
DithranolNon-sterile
Domperidone Non-sterile
Donepezil HydrochlorideNon-sterile
Dosulepin HydrochlorideNon-sterile
Doxazosin MesilateNon-sterile
Doxepin HydrochlorideNon-sterile
Doxycycline hyclateNon-sterile
Dutasteride  Non-sterile
Enalapril maleateNon-sterile
EntacaponeNon-sterile
Eosin SodiumNon-sterile
Ephedrine Non-sterile
Ephedrine HydrochlorideNon-sterile
ErgocalciferolNon-sterile
Ergotamine Tartrate Non-sterile
ErythromycinNon-sterile
Estradiol Non-sterile
Estriol Non-sterile
Ethambutol HydrochlorideNon-sterile
Ethinyl estradiolNon-sterile
Exemestane Non-sterile
EzetimibeNon-sterile
Ferrous SulphateNon-sterile
FinasterideNon-sterile
Flecainide acetateNon-sterile
Flucloxacillin magnesium Octa hydrateNon-sterile
Flucloxacillin SodiumNon-sterile
Flucloxacillin Sodium mono HydrateNon-sterile
FluconazoleNon-sterile
Fludrocortisone Non-sterile
Fludrocortisone Acetate Non-sterile
Flunarizine dihydrochlorideNon-sterile
Fluocinolone AcetonideNon-sterile
FluocinonideNon-sterile
Fluoxetine hydrochlorideNon-sterile
Fluphenazine HydrochlorideNon-sterile
Fluvoxamine MaleateNon-sterile
Folic acidNon-sterile
FormaldehydeNon-sterile
FurosemideNon-sterile
Fusidic acid Non-sterile
GabapentinNon-sterile
Galantamine hydrobromideNon-sterile
Gentamycin Sulphate Non-sterile
GlibenclamideNon-sterile
GliclazideNon-sterile
Glycerl trinitrateNon-sterile
GlycerolNon-sterile
GlycineNon-sterile
Glycopyronium Bromide Non-sterile
GriseofulvinNon-sterile
HaloperidolNon-sterile
HeparinInjection
Heparin Sodium BovineNon-sterile
Heparin Sodium PorcineNon-sterile
HyaluronidaseInjection
Hydralazine HydrochlorideNon-sterile
HydrochlorothiazideNon-sterile
HydrocortisoneNon-sterile
HydroquinoneNon-sterile
HydroxycarbamideNon-sterile
Hydroxychloroquine sulphateNon-sterile
Hydroxyzine HydrochlorideNon-sterile
Hyoscine ButylbromideNon-sterile
Hyoscine HydrobromideNon-sterile
Hyoscine HydrochlorideNon-sterile
Ibuprofen Non-sterile
IchthammolNon-sterile
IndapamideNon-sterile
Indometacin Non-sterile
Indomethacin Non-sterile
InsulinInjection
IrbesartanNon-sterile
IsoniazidNon-sterile
Isosorbide DinitrateNon-sterile
Isosorbide MononitrateNon-sterile
ItraconazoleNon-sterile
Ketamine hydrochlorideNon-sterile
Labetalol HydrochlorideNon-sterile
Lactic acidNon-sterile
LamotrigineNon-sterile
LansoprazoleNon-sterile
Latanoprost  Non-sterile
LevamisoleNon-sterile
LevetiracetamNon-sterile
LevetiracetamInjection
LevodopaNon-sterile
LevomepromazineNon-sterile
Levomepromazine HydrochlorideInjection
Levothyroxine SodiumNon-sterile
Levothyroxine sodium Non-sterile
Lidocaine HydrochlorideNon-sterile
LinagliptinNon-sterile
Liothyronine sodium Non-sterile
Lisinopril dihydrateNon-sterile
Loperamide Hydrochloride Non-sterile
LorazepamNon-sterile
Losartan PotassiumNon-sterile
Magnesium CarbonateNon-sterile
Magnesium GlycerophosphateNon-sterile
Magnesium hydroxideNon-sterile
Magnesium OxideNon-sterile
Magnesium SulphateNon-sterile
Mebeverine hydrochloride Non-sterile
Mefenamic acidNon-sterile
Megestrol AcetateNon-sterile
MelatoninNon-sterile
Menadiol Sodium PhosphateNon-sterile
MentholNon-sterile
Mepacrine HydrochlorideNon-sterile
MercaptopurineNon-sterile
Mesalazine Non-sterile
MetaraminolInjection
Metformin hydrochlorideNon-sterile
Methadone hydrochlorideNon-sterile
MethotrexateNon-sterile
Methyl SalicylateNon-sterile
Methylphenidate HydrochlorideNon-sterile
Metoclopramide hydrochlorideNon-sterile
MetolazoneNon-sterile
Metoprolol tartrateNon-sterile
MetronidazoleNon-sterile
Metronidazole benzoateNon-sterile
Mexiletine HydrochlorideNon-sterile
MidazolamNon-sterile
MidodrineNon-sterile
MilrinoneInjection
MirtazapineNon-sterile
ModafinilNon-sterile
Mometasone FuroateNon-sterile
MonobenzoneNon-sterile
Morphine SulfateInjection
Morphine SulphateNon-sterile
Mycophenolate MofetilNon-sterile
NadololNon-sterile
Naltrexone HydrochlorideNon-sterile
NaproxenNon-sterile
Neomycin SulphateNon-sterile
NicotinamideNon-sterile
NifedipineNon-sterile
NitrazepamNon-sterile
NitrofurantoinNon-sterile
NorethisteroneNon-sterile
Nortriptylline HydrochlorideNon-sterile
OlanzepineNon-sterile
Olmesartan MedoxomilNon-sterile
OmeprazoleNon-sterile
Ondansetron HydrochlorideNon-sterile
Oxybutynin hydrochlorideNon-sterile
Oxycodone HydrochlorideInjection
Oxycodone Hydrochloride Non-sterile
Pantoprazole Sodium SesquihydrateNon-sterile
ParacetamolNon-sterile
Paracetamol Non-sterile
Paroxetine hydrochloride hemihydrateNon-sterile
Penicillin V calciumNon-sterile
Penicillin V potassiumNon-sterile
Peppermint Non-sterile
Peppermint waterNon-sterile
Perindopril Tert-ButylamineNon-sterile
Phenobarbital sodium Non-sterile
PhenolNon-sterile
PhentoxyfyllineNon-sterile
Phenylephrine HydrochlorideNon-sterile
Phenylephrine HydrochlorideNon-sterile
Phenytoin sodium Non-sterile
Phosphoric acidNon-sterile
PhytomenadioneNon-sterile
Pilocarpine HydrochlorideNon-sterile
Pirenzepine HydrochlorideNon-sterile
PizotifenNon-sterile
Potassium acid phosphateNon-sterile
Potassium bicarbonateNon-sterile
Potassium ChlorideNon-sterile
Potassium citrateNon-sterile
Potassium Hydrogen CarbonateNon-sterile
Pravastatin Sodium Non-sterile
Prazosin HydrochlorideNon-sterile
PrednisoloneNon-sterile
PregabalinNon-sterile
Pregnenolone Non-sterile
PrimidoneNon-sterile
ProbenacidNon-sterile
Progesterone Non-sterile
Promazine hydrochloride Non-sterile
Promethazine HydrochlorideNon-sterile
Propranolol hydrochlorideNon-sterile
Propylthiouracil Non-sterile
Protamine SulfateNon-sterile
Protamine SulphateInjection
PyrazinamideNon-sterile
Pyridostigmine BromideNon-sterile
Pyridoxine Non-sterile
Pyridoxine HydrochlorideNon-sterile
Quetiapine FumarateNon-sterile
Quinine bisulphateNon-sterile
Quinine sulphateNon-sterile
RamiprilNon-sterile
Ranitidine hydrochlorideNon-sterile
ResorcinolNon-sterile
rFSHInjection
RiboflavinNon-sterile
RifaximinNon-sterile
RiluzoleNon-sterile
RisperidoneNon-sterile
Ropinirole Hydrochloride Non-sterile
Rosuvastatin Calcium Non-sterile
Salicylic acidNon-sterile
SennosideNon-sterile
Sertaline HydrochlorideNon-sterile
Sildenafil citrateNon-sterile
Silver nitrateNon-sterile
SimvastatinNon-sterile
Sitagliptin Phosphate MonohydrateNon-sterile
Sodium acid phosphateNon-sterile
Sodium AlginateNon-sterile
Sodium benzoateNon-sterile
Sodium bicarbonateNon-sterile
Sodium chlorideNon-sterile
Sodium citrateNon-sterile
Sodium oxybateNon-sterile
Sodium phenylbutyrateNon-sterile
Sodium valporateNon-sterile
Sodium ValproateInjection
Solifenacin succinateNon-sterile
Sotalol HydrochlorideNon-sterile
SpironolactoneNon-sterile
SucralfateNon-sterile
SugammadexInjection
Sulfadiazine Non-sterile
SulphurNon-sterile
Sulpiride Non-sterile
Tacrolimus monohydrateNon-sterile
Tamoxifen citrateNon-sterile
Tamsulosin HydrochlorideNon-sterile
TemazepamNon-sterile
Terbinafine HydrochlorideNon-sterile
Testosterone Non-sterile
TetrabenazineNon-sterile
Thaimine HydrochlorideNon-sterile
TheophyllineNon-sterile
Tizanidine HydrochlorideNon-sterile
Tolterodine tartrateNon-sterile
TopiramateNon-sterile
Tranexamic acidNon-sterile
Trazodone hydrochlorideNon-sterile
TretinoinNon-sterile
Trihexiphendyl HydrochlorideNon-sterile
UreaNon-sterile
Ursodeoxycholic acidNon-sterile
Valproic acidNon-sterile
Vancomycin HydrochlorideNon-sterile
Venlafaxine HydrochlorideNon-sterile
Warfarin sodiumNon-sterile
Yohimbine Hydrochloride Non-sterile
Zinc Non-sterile
ZonisamideNon-sterile
ZopicloneNon-sterile
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