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Study Designs

BioPharma Services has completed a wide range of Study Designs for our Sponsors

BioPharma Services’ expert Pharmacokinetics team produces custom Study Designs for a wide variety of clinical trials. Please find a wide selection of our study designs for your review. If the study design you require is not listed, please Contact Us to discover how we can support your clinical trial with our award-winning end to end approach which includes protocol development, clinical execution, bioanalysis, scientific regulatory affairs, data management, and medical writing.

Study Designs

CompoundFormulation Strength (mg)AgencyRelease DateNotes
AcalabrutinibCapsule100FDAAug 2021
AcamprosateTablet DR333FDAOct 2021
AcetazolamideTablet250AllNov 2021
AfatinibTablet50EMANov 2020
Albuterol sulfate Aerosol metered0.09FDANov 2021
AlitretinoinCapsule30EMAAug 2020
AlvimopanCapsule12FDAOct 2021
Ambrisentan/TadalafilTablet10/40EMADec 2021
AmlodipineTablet10EMAJuly 2022
Amlodipine/Perindopril/IndapamideCapsule ER
10/10/1.5
EMAMar 2022505b2 (New FDC)
AmphetamineTablet ODT ER18.8FDAJune 2022
Amphetamine mixed saltsCapsule ER30FDASept 2022
Amphotericin BInjectable liposomal50AllJune 2022
ApalutamideTablet60FDAAug 2021
ApixabanTablet5EMAApr 2020
AprepitantCapsule125FDAJuly 2020
Atorvastatin/EzetimibeTablet80/10EMAJan 2023
AxitinibTablet5AllDec 2022
Azelastine/FluticasoneSpray metered0.137/0.05AllJan 2022
Azilsartan medoxomilTablet80EMAAug 2022
Azilsartan/ChlorthalidoneTablet40/25EMANov 2021
BaricitinibTablet2AllJan 2022
Bempedoic AcidTablet180FDAJan 2022
Betamethasone DipropionateCream0.5EMAJan 2020PD endpoint
BexaroteneCapsule75EMAApr 2021
Bisoprolol FumarateTablet10FDAJune 2021
BosentanTablet125TPDApr 2022
BosutinibTablet500EMADec 2021
BrivaracetamTablet100AllMar 2022
BromazepamTablet6EMADec 2020
BudesonideCapsule ER4FDAJan 2022505b2 (New Strength)
BudesonideCapsule ER4FDAMay 2022
BudesonideTablet ER9FDAMar 2022
Budesonide/FormoterolPowder metered0.16/0.0045EMAJuly 2021
Budesonide/FormoterolPowder metered0.4/0.012TPDJuly 2021
BuprenorphineSublingual Tablet8FDAApr 2021
Buprenorphine/NaloxoneFilm12/3FDASept 2022
Buprenorphine/NaloxoneSublingual Tablet11.4/2.9FDASept 2022
Bupropion HCLTablet ER300FDANov 2022
Buproprion/DextromethorphanTablet105/45AllFeb 2021
CannabidiolSolution100FDAOct 2021And EMA
Cannabidiol/THCBuccal Spray25/27EMAOct 2021
Carbidopa/LevodopaTablet25/250EMADec 2022
Carglumic AcidTablet for suspension200FDASept 2020
CariprazineCapsule1.5EMAAug 2020
Chenodeoxycholic acidCapsule250EMAMay 2022
ChlorthalidoneTablet50TPDJune 2021
CilostazolTablet100-50TPDJan 2022
CiprofloxacinTablet750EMAMar 2022
Clorazepate DipotassiumTablet15FDAJune 2022
ColchicineTablet0.6FDAJuly 2021505b2 (New Strength)
Dapagliflozin/MetforminTablet10/1000EMAFeb 2020
Dapagliflozin/MetforminTablet10/1000TPDFeb 2020
Dapagliflozin/SitagliptinTablet10/100EMAApr 2021
DasatinibTablet140EMAOct 2021
DasatinibTablet140TPDJan 2020
DasatinibTablet100FDAJan 2020
DasatinibTablet100TGAJan 2020
DeferiproneTablet1000FDAFeb 2022For NDA#21825 (tid)
DeferiproneTablet1000FDAFeb 2022For NDA#212269 (bid)
Desogestrel/Ethinyl EstradiolTablet0.15/0.02EMAFeb 2022
Desogestrel/Ethinyl EstradiolTablet0.15/0.03EMAMay 2022
DexlansoprazoleCapsule ER60FDAFeb 2020
DexlansoprazoleCapsule DR60EMADec 2021
Dexmethylphenidate HClCapsule ER40FDAFeb 2022
DiazoxideSuspension50 mg/mLFDAApr 2020
Diclofenac diethylamineGel0.0116EMAMar 2022And TPD
Diclofenac sodiumTablet DR25-75FDAJan 2021
Dimethyl FumarateCapsule DR240EMANov 2021
Dimethyl FumarateCapsule DR240FDANov 2021
Dimethyl FumarateCapsule DR240TPDNov 2021
DiphenhydramineSuspension injection50 mg/mLFDAJune 2020
Docusate sodiumCapsule100MHRAJan 2022
Dofetilide and MexiletineCapsule0.5/275FDAOct 2020505b2 (New FDC)
Donepezil HCl/Memantine HClCapsule ER10/28FDANov 2021
DonezepilDepot70-280FDAApr 2020Phase 1
DoxepinCapsule50EMAMay 2020
DuloxetineCapsule ER60EMADec 2021
EdavaroneSuspension100FDAMar 2020505b2 (New formulation)
EdavaroneSuspension105FDAOct 2022
EdoxabanTablet60EMAMay 2022
ElagolixTablet200EMAJan 2021
ElagolixTablet200FDAJan 2021
EltrombopagTablet75EMAJuly 2020
EmpagliflozinTablet25EMANov 2021
Empagliflozin/MetforminTablet12.5/1000EMANov 2021EMA
Emtricitabine tenofovir rilpivirineTablet200/25/25EMASept 2022
EnalaprilTablet20EMAFeb 2020
Enoxaparin sodiumInjection solution/Supension100 mg/mLFDADec 2021
EnzalutamideCapsule80AllJan 2022
Eplerenone/ TorasemideTablet50/10EMADec 2021505b2 (New FDC)
Escitalopram OxalateTablet20EMADec 2021
EsomeprazoleTablet DR40FDASept 2020
EstradiolFilm0.025mg/24hFDAFeb 2021Irritation and sensitization
EstradiolRing2FDAMar 2020
EstrogenCream0.625FDAAug 2021
EstrogensCream0.625FDAAug 2021
Ethinly Estradiol/ Norethindrone acetateTablet1/0.5AllFeb 2022
Ethinly Estradiol/ Norethindrone acetateTablet1/0.5AllFeb 2022
Ethinly Estradiol/ Norethindrone acetateTablet0.01/1FDASept 2021
Ethinyl estradiol/NorelgestrominFilm0.035-0.15/24hFDAAug 2022Irritation and sensitization
Ethinyl estradiol/NorelgestrominFilm0.035-0.15/24hFDAAug 2022PK-adhension
Ethinyl estradiol/segesterone acetateRing0.013/0.15FDAJune 2022
Ethinyl estradiol/Segesterone acetateRing0.013-0.15/24hFDAJune 2022
FavipiravirTablet200EMANov 2021
Ferric CarboxymaltoseInjection solution/Supension50mg/mLFDAJune 2021And EMA
Finasteride/TadalafilTablet5/5EMANov 2020Drug interaction (mono vs Co-administration)
Fingolimod HClCapsule0.5AllJuly 2021
FlucytosineCapsule500FDAJuly 2021And EMA
Fluticasone/Umeclidinium/VilanterolPowder metered200/62.5/25 mcgFDAFeb 2022PK endpoint design
Fluticasone/VilanterolPowder metered0.2/0.025FDASept 2022PK endpoint design
Formoterol FumarateInjection solution/Supension12 mcgFDAFeb 2022PK profiling
FulvestrantInjection solution/Supension250mg/5mLFDAMar 2020Per request only
GabapentinCapsule400EMAMar 2021
GabapentinCapsule400FDAMar 2021
GilteritinibTablet40AllDec 2021
Glycopyrronium bromidePowder metered44 mcgEMASept 2022
GonadotropinInjection75 IUEMAJan 2021
Guaifenesin/DextromethorphanLiquid100/5FDANov 2022
Guanfacine HClTablet ER1-4AllNov 2021
Hydrocodone bitartrateTablet ER20FDANov 2021PK intact form
HydrocortisoneSolution100 mg/6mLFDADec 2021for enema
HydroxyureaCapsule500TPDSept 2021
IbrutinibTablet560EMADec 2022
IbrutinibTablet560FDADec 2022
IbuprofenTablet ER600TPDJan 2022
IbuprofenTablet200FDASept 2021
Ibuprofen LysineTablet684EMAApr 2021
ImatinibTablet400FDAFeb 2022And EMA
Indacaterol/GlycopyrroniumPowder metered85/43 mcgEMAAug 2022
IndapamideTablet ER1.5EMAJan 2022
Indapamide/RamiprilTablet ER1.5/10 mgEMASept 2022
IndomethacinSuppository50FDAMay 2020
Inosine PranobexTablet500EMAOct 2021
Ipratropium BromideAerosol metered0.021FDASept 2022
IsotretinoinCapsule40AllDec 2021
IvacaftorTablet150AllMay 2021
IvermectinTablet3FDAOct 2022
IvosidenibTablet250FDASept 2020
LacosamideSuspension10mg/mLEMAApr 2020Syrup
LanreotideInjection solution/Supension120EMANov 2020
LanreotideInjection solution/Supension120EMAMar 2021Multiple dose
Lanthanum CarbonateTablet chewable1000FDAJuly 2021PD endpoint
LenalidomideTablet25AllJuly 2020
LetrozoleTablet2.5EMAMay 2022
Leuprolide AcetateInjection suspension ER7.5FDAFebAnd EMA
LevetiracetamTablet ER750FDAOct 2022
Carbidopa/LevodopaTablet ER50/200FDAMay 2021
Carbidopa/LevodopaTablet ER87.5/350FDAJune 2021Alcohol interaction
LevofloxacinTablet500EMAJan 2021
LevothyroxineTablet0.3TPDFeb 2020
Levothyroxine SodiumSublingual Tablet0.3FDAMay 2022505b2 (New formulation)
LinagliptinTablet5EMAMar 2022
Linagliptin/MetforminTablet2.5/1000EMAMar 2022And TPD
LiothyronineTablet0.05AllDec 2021
Liraglutide RecombinantInjection6mg/mLEMAJan 2022
Liraglutide RecombinantInjection6mg/mLFDAJan 2022
Liraglutide RecombinantInjection6mg/mLTPDSept 2021
LisdexamfetamineCapsule70AllJan 2022
LisdexamfetamineTablet chewable60FDAMay 2022
LisdexamfetamineSolution10FDAApr 2021505b2 (New formulation)
LofexidineTablet0.18FDADec 2020
LoperamideCapsule2TPDMar 2022
LoprazolamCapsule2OtherJune 2022For South Africa
LurasidoneTablet37EMAApr 2021
MacitentanTablet10EMAJan 2020
MacitentanTablet10TPDJune 2021
Macitentan/TadalafilTablet10/40EMAApr 2022And TPD
Mebeverine HClCapsule ER200AllMar 2022
MeloxicamInjection30FDAJune 2021
MercaptopurineSuspension20FDAFeb 2022
MesalamineCapsule ER500FDAApr 2022
MesalamineCapsule ER800FDAOct 2022
MesalamineCapsule ER1200FDANov 2021
MesalamineTablet ER1000EMAMar 2020
MesalamineCapsule ER375FDAJuly 2021
MesalamineTablet ER1200EMANov 2021
MetforminTablet1000AllJan 2022
MetforminTablet ER1000AllDec 2020
Metformin/Empagliflozin/LinagliptinTablet1000/25/5FDAAug 2022BE for FDA and 505b2 for EMA (new FDC)
Methylnaltrexone BromideTablet150FDAMay 2021
MethylphenidateTablet chewable ER40FDADec 2020
MethylphenidateTablet for suspension25mg/5mLFDADec 2020
MethylphenidateCapsule ER60FDAJan 2023
MetolazoneTablet10FDAJune 2021
Metoprolol succinateTablet ER200FDANov 2020
MianserinTablet60EMADec 2020
MidostaurinCapsule25AllDec 2020
MisoprostolTablet0.2FDAJune 2020
MometasoneSpray0.05FDAJune 2020
MometasoneOintment0.001TPDJuly 2020PD endpoint
MorphineTablet30FDAJune 2020
MoxidectinTablet2FDAJan 2022
Mycophenolate MofetilSuspension200mg/mLFDAOct 2021
N-AcetylcysteinTablet effervescent600OtherMay 2020for NMPA
NalmefeneTablet18EMANov 2020
NaloxoneInjection0.4mg/mLFDAJune 2020
NebivololTablet20FDAMay 2021
Nebivolol/ HydrochlorothiazideTablet5/12.5EMAMar 2022
NeratinibTablet240FDAAug 2021
NilotinibCapsule200EMASept 2022
NilotinibCapsule200FDASept 2022
NimodipineCapsule30FDASept 2021
NimodipineInjection solution/Supension0.0002FDAOct 2022505b2 (New formulation)
Nirmatrelvir/RitonavirTablet150/100WHOSept 2022
NitrofurantoinSuspension25mg/5mLFDASept 2021
NortriptylineTablet75AllJuly 2021and for Capsule
Obeticholic acidTablet10EMAMar 2022And TPD
Obeticholic acidTablet10FDAMar 2022
OlanzapineSuspension5FDADec 2021505b2 (New formulation)
OrlistatCapsule60FDAAug 2021PD endpoint
OseltamivirCapsule75EMAJune 2020
Otilonium bromideTablet40EMADec 2021
OxycodoneTablet ER30FDAMar 2022Nasal PK
OzanimodCapsule0.92FDAApr 2022and EMA
PalbociclibCapsule125EMASept 2021
PalbociclibTablet125EMASept 2021
PalbociclibTablet ER125EMAOct 2021DDI study with PPI
PalbociclibTablet125FDADec 2020
Palbociclib/LetrozoleTablet125/2.5EMAApr 2022505b2 (new FDC) - PPI Pre-treatment
PaliperidoneTablet ER6FDADec 2021
PazopanibTablet400AllJuly 2022
PerampanelPellet12AllDec 2020505b2 (New formulation)
Perindopril arginine/ IndapamideTablet10/2.5AllDec 2021
Perindopril arginine/AmlodipineTablet10/10NMPAOct 2021
PhytonadioneInjection10mg/mLFDAAug 2022
PhytonadioneInjection10mg/mLFDAAug 2022505b2 (New Strength)
Pitavastatin/EzetimibeTablet4-10EMAJan 2021505b2 (New FDC)
PitolisantTablet17.8FDAFeb 2022
PomalidomideCapsule4EMAAug 2022
PomalidomideCapsule4FDANov 2022
PomalidomideCapsule4TPDNov 2022
PonatinibTablet45EMAJan 2022
PonatinibTablet45FDAJan 2022
PrednisoloneTablet25EMAMar 2022
PrednisoneTablet ER5FDAJune 2020
PregabalinTablet ER330FDADec 2019
PregabalinCream0.1EMAAug 2022Phase 1
ProgesteroneCapsule200EMAJuly 2021
ProgesteroneCapsule200AllSept 2021
PropofolInjection0.01FDAMar 2021505b2 (New formulation)
Pyrantel EmbonateTablet chewable250EMAJune 2020
Pyridostigmine BromideTablet ER275FDAJuly 2021Phase 1
RamiprilTablet10EMAOct 2022
Ramipril/IndapamideTablet10/2.5EMANov 2021505b2 (new FDC)
Ramipril/IndapamideTablet ER10/1.5EMASept 2022505b2 (new FDC)
RanolazineTablet ER750EMAMay 2021
RegorafenibTablet40EMAApr 2021
RibociclibTablet200FDADec 2020
RifaximinTablet550FDAMay 2020
RifaximinTablet200EMAMay 2020
RitonavirTablet100WHOJuly 2022
RivaroxabanTablet20AllNov 2020
RivaroxabanTablet20EMAApr 2022Crushed with apple sauce
Rosuvastatin/CandesartanTablet20/32EMAJan 2022505b2 (New formulation)
RotigotinePatch2mg/24hEMAAug 2020PK-adhension
RotigotinePatch2mg/24hEMAAug 2020Irritation and sensitization
RoxadustatCapsule100NMPAJune 2020
RupatadineTablet10TPDNov 2022
RuxolitinibTablet20EMANov 2022
RuxolitinibTablet20TPDNov 2022
RuxolitinibTablet ER50FDANov 2022505b2 (New formulation)
Sacubitril/ValsartanTablet97/103AllFeb 2022
SelegilinePatch6mg/24hFDADec 2020PK-adhension
SemaglutideInjection solution/Supension1EMAMar 2021
SemaglutideTablet14FDASept 2021
SertralineTablet200EMANov 2020505b2 (New Strength)
SiponimodTablet2FDAOct 2021
SitagliptinTablet100AllOct 2021
Sitagliptin/MetforminTablet50/1000AllSept 2022
Sitagliptin/MetforminTablet ER100/1000AllAug 2022
Sodium OxybatePowder for suspension9FDAMar 2021505b2 (New formulation)
SofosbuvirTablet400AllOct 2021
Solifenacin succinate/Tamsulosin hydrochlorideTablet ER6/0.4EMAJuly 2021
SumatriptanTablet100EMAJan 2021
SunitinibTablet50AllJuly 2021
SuvorexantTablet20FDAFeb 2022
TacrolimusCapsule5FDAJan 2022
TacrolimusCapsule ER4FDAJan 2022
TadalafilTablet ODT20EMAJune 2022
TafamidisCapsule61FDAMay 2021
TapentadolTablet ER250AllFeb 2022
TeduglutideInjection powder 5EMAMar 2021
Telmisartan/IndapamideTablet ER80/1.5EMAMay 2021
Tenofovir disoproxil fumarateTablet300TPDSept 2021
TicagrelorTablet90EMAMay 2021
Timonacic AcidTablet100EMAApr 2022
Timonacic AcidTablet100EMAMay 2022Dose proportional
Tiotropium BromidePowder metered2.5 mcgAllSept 2022PK endpoint design
TofacitinibTablet ER22FDAFeb 2022
TofacitinibTablet10EMAAug 2021
TolvaptanTablet90AllDec 2020
TopiramateCapsule ER200FDAOct 2020
Tramadol/DexketoprofenTablet75/25EMAJan 2022
TrametinibTablet2FDAJune 2022and EMA
TranylcypromineTablet10EMAMar 2021
TrazodoneTablet ER150EMAMar 2021
TriazolamTablet0.25AllFeb 2022
Ulipristal AcetateTablet30EMASept 2022
UpadacitinibTablet ER45FDAJune 2022
UrsodiolTablet500FDAMay 2020
Valsartan/HydrochlorothiazideTablet320/25EMAMar 2022
VareniclineTablet ER2EMAMay 2020505b2 (New Strength)
VenetoclaxTablet100FDAFeb 2022
VenetoclaxTablet100EMAFeb 2022
VenetoclaxTablet400FDAMar 2022and EMA
VerapamilTablet ER360FDAJan 2023
VerapamilTablet ER300FDANov 2022
VigabatrinTablet500FDAMar 2021
Vildagliptin/MetforminTablet50/1000EMAApr 2020
VismodegibCapsule150EMADec 2022
VoclosporinCapsule7.9FDASept 2022
VortioxetineTablet20EMANov 2021
VortioxetineTablet20TPDMay 2020
Zolpidem TartrateTablet12.5FDAFeb 2020505b2 (pilot)
ZonisamideTablet300EMAApr 2020505b2 (New formulation)
Abbreviation Full name Country /Organization of origin
FDA U.S. Food and Drug Administration United States
EMA European Medicines Agency European Union
TPD Pharmaceutical Drugs Directorate (formerly the Therapeutic Products Directorate) Canada
TGA Therapeutic Goods Administration Australia
NMPA National Medical Products Administration China
ANVISA The Brazilian Health Regulatory Agency Brazil
GCC Gulf Cooperation Council The Arab States of the Gulf
ASEAN Association of Southeast Asian Nations Southeast Asian Countries
WHO World Health Organization World Health Organization

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